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INTRODUCTION | gastrointestinal cancer | RECTAL ADENOCARCINOMA, GASTROINTESTINAL CANCER | Great progress in technique and device development has been made in endoscopic resection of early-stage gastrointestinal cancer with endoscopic mucosal resection and endoscopic submucosal dissection (ESD) (The synthetic self-assembling peptide, TDM-621 (3-D Matrix, Tokyo, Japan), is derived from nonliving sources and consists of 16 amino acid residues. It is usually in the form of an aqueous solution (that easily passes through the catheter) but can form a gel (self-assembling) under specific physiological conditions (neutral pH or an environment in which salts such as NaTDM-621 has noninvasive properties, including safety and operability, and is a safe material that may contribute to hemostasis in the gastrointestinal endoscopic treatment field. However, no clinical studies have fully examined its efficacy and safety in the gastrointestinal field in a multicenter randomized setting. This multicenter, open-label, randomized controlled trial aimed to clarify the efficacy and safety of TDM-621 in achieving hemostasis during ESD in patients with gastric or rectal adenocarcinomas for which ESD is indicated. | PMC9889198 |
METHODS | This multicenter, randomized, open-label, parallel-group comparative trial was conducted from August 2017 to August 2019 with the approval of the Institutional Review Board of each facility in compliance with relevant laws and regulations, including the Declaration of Helsinki and the Japanese Ministerial Ordinance on Good Clinical Practice for Medical Devices. The study was registered in the University Hospital Medical Information Network clinical trial registration system (UMIN000042009). Before conducting the study, the principal investigator or subinvestigators explained the details of the study to the patients and obtained their written informed consent. | PMC9889198 | ||
Patients | gastric/colorectal cancer, cancer, hypersensitivity, blood coagulation | INFLAMMATORY BOWEL DISEASE, CARCINOMA OF THE STOMACH, CANCER, ULCERATION, HYPERSENSITIVITY | Patients for whom ESD was indicated (following the Japanese gastric/colorectal cancer treatment guidelines and the gastric/colorectal ESD/endoscopic mucosal resection guidelines) (The exclusion criteria were as follows: residual or local recurrent lesions, ulceration of the target lesions, poorly differentiated adenocarcinoma or undifferentiated carcinoma of the stomach or rectum, inflammatory bowel disease, a history of hypersensitivity to peptide preparations or protein preparations, and a performance status grade of 2 or higher based on the clinical evaluation criteria for cancer chemotherapy. Patients who were considered ineligible for the study by a principal investigator or subinvestigators, those who were receiving blood coagulation drugs (hemocoagulase, among others) and antifibrinolytic agents (tranexamic acid and aprotinin preparations, among others), and cases in which oozing was not observed during surgery were excluded. | PMC9889198 |
Study protocol | JET | ESD-trained endoscopists who had performed more than 20 ESD procedures participated in the study (In the TDM-621 group, hemostasis was performed using TDM-621, and coagulation hemostasis was performed using hemostatic forceps (Coagrasper, Olympus, Tokyo, Japan) if hemostasis was not achieved within 3 minutes. TDM-621 was administered through a TDM-621 application catheter (FINE JET, Top, Tokyo, Japan) (see Supplementary Video 1, Supplementary Digital Content 6, | PMC9889198 | |
Outcome measurements | bleeding | SECONDARY, EVENT, BLEEDING | The primary efficacy end point was the mean number of coagulations (performed with hemostatic forceps), as determined by the third-party evaluation committee.The secondary efficacy end points were the mean number of coagulations (determined by the operator), time from confirmation of a blood oozing event to the completion of hemostasis (determined by the third-party evaluation committee and the operator), time from the initiation to the completion of ESD (determined by the operator), and the time from coagulation to the completion of ESD (determined by the operator).Secondary end points for the TDM-621 group also included the number of sites in which hemostasis was achieved using TDM-621 alone, the number of sites in which bleeding recurred after achieving hemostasis, and the number of times those sites received additional treatment for hemostasis. The hemostasis and operation times were determined by the third-party evaluation committee and the operator. The amount of TDM-621 applied and the operability for the application of TDM-621 based on the operator's judgment were also evaluated in each case, based on 2 criteria: “it could be applied appropriately to the target site” and “it could not be applied appropriately to the target site.” | PMC9889198 |
Safety evaluation | ADVERSE REACTIONS, POSTOPERATIVE BLEEDING | The incidence of defects derived from TDM-621 treatment and AE (including abnormalities in clinical test values, postoperative bleeding for 7 and 28 days after ESD, and adverse reactions) were assessed for the evaluation of safety. | PMC9889198 | |
Sample size and statistical analysis | SECONDARY, ADVERSE REACTIONS | The mean number of coagulations during ESD with hemostatic forceps (the primary efficacy end point) was assumed to be 3.1 in the control group and 2.1 in the TDM-621 group, based on our pilot study. Based on this assumed mean value, simulated data were created using random numbers according to a Poisson distribution. The required number of patients in each group, calculated with a simulation (1,000 times) to ensure equality of distribution in the 2 groups using a Wilcoxon rank sum test (detection power of 80% at the significance level), was 44. The SD of the total number of cauterizations was 2.3, while the SD in the Poisson distribution (mean value of 3.1) was 1.76. When the SD was 1.3, the required sample size was approximately 1.52; thus, the required sample size was adjusted to 80 patients in each group.The primary, secondary, and other end points for efficacy were analyzed with the per protocol set (PPS) that represented compliance with the protocol. For the total number of cauterizations per patient treated with hemostatic forceps, a summary statistic (number of patients, mean, SD, median, minimum, maximum) was calculated. Superiority was confirmed with a significance level of 5% on both sides by comparing the groups using the Wilcoxon rank sum test. The number of cauterizations according to the operator's judgment was analyzed similarly to the primary efficacy end point. For other end points, summary statistics were calculated, and the Wilcoxon rank sum and Fisher exact tests were performed for intergroup comparisons. Safety was analyzed for the safety population (SP) and replaced as the lowest level term based on MedDRA/J version 22.1. Adverse reactions were classified with the system organ class and preferred terms and calculated using 95% confidence intervals. The Fisher exact test was used to compare the incidence rate between the groups, and statistical significance was set at | PMC9889198 | |
RESULTS | PMC9889198 | |||
Composition of patients | bleeding | BLEEDING | A total of 227 patients were enrolled from the 7 facilities and randomized (TDM-621 group, 112; control group, 115). Of them, 33 in both groups were excluded because of good clinical practice deviation, unavailability of record video, and misinclusion of bleeding in which bleeding source was identifiable after a single wash with a water jet during ESD (Figure Composition of patients. ( | PMC9889198 |
Demographic and other baseline characteristics | Table Baseline demographic and clinical characteristics of the patients (PPS) | PMC9889198 | ||
Primary and secondary efficacy end points | SECONDARY | The mean number of coagulations (the primary efficacy end point) determined by the third-party evaluation committee was significantly higher in the control group (4.9 ± 5.2) than in the TDM-621 group (1.0 ± 1.4) (Effect of TDM-621 on the number of cauterizations with hemostats (PPS). Data are provided as mean ± SD. *Other secondary efficacy end points (PPS)Table Hemostasis condition in the TDM-621 group (PPS) | PMC9889198 | |
Other end points | tumors | TUMORS | The amount of TDM-621 applied was 1.75 ± 2.14 mL according to the operator's determination, and the operability was evaluated as “appropriately applied to the target site” in 85 patients (98.8%), all but 1. All targeted tumors were successfully removed | PMC9889198 |
Safety results | post-ESD coagulation syndrome, fever, abdominal pain | ADVERSE REACTIONS, INFLAMMATION, ADVERSE EVENTS | The AE incidence rate was 39.6% in the TDM-621 group and 37.6% in the control group, with no significant differences between the groups. The incidence rate of adverse reactions was 1.0% in the TDM-621 group, and no adverse reactions were observed in the control group. No defects derived from TDM-621 occurred in any patients.Table Frequency of adverse events based on CTCAE in either group (SP)Regarding symptoms of post-ESD coagulation syndrome, such as fever, localized abdominal pain, and inflammation, several cases were observed in both the control and TDM-621 groups; however, there was no significant difference in the incidence between the 2 groups. | PMC9889198 |
DISCUSSION | blood spurting, bleeding, death, blood oozing | SECONDARY, RECTAL TUMORS, BLEEDING | This study showed that TDM-621 is a useful hemostatic peptide for blood oozing during ESD for gastric or rectal tumors and that severe AE do not occur with this peptide solution.This is the first multicenter, randomized, parallel-group comparative study to directly compare the efficacy and safety of TDM-621 with those of conventional hemostatic methods for blood oozing during endoscopic resection. In this study, the number of coagulations with hemostatic forceps (the primary efficacy end point) was significantly reduced in the TDM-621 group compared with that in the control group. TDM-621 showed the efficacy to reduce the number of coagulations with hemostatic forceps by both highly and less experienced endoscopists.A significant decrease in the number of cauterizations (the secondary efficacy end point) was shown, as determined by the operator, verifying the usefulness of TDM-621. The degree of dispersion of the number of cauterizations was markedly smaller in the TDM-621 group than in the control group. This result provides evidence that TDM-621 treatment reduced the number of coagulations considerably and suggests that treatment with TDM-621 can reduce the physical burden on patients during the procedure. There was no difference in the incidence of postcoagulation bleeding between the TDM-621 and control groups, which suggests that the hemostatic effects of TDM-621 were similar to those of the usual hemostasis methods during the procedure. The hemostasis achievement rate with TDM-621 treatment alone was 62.2%.The time from blood oozing to achievement of hemostasis was significantly longer in the TDM-621 group than in the control group. This result may be because we set the time from the beginning of the TDM-621 treatment to the achievement of hemostasis to a maximum of 3 minutes. Furthermore, the time required for coagulation might increase while preparing the hemostatic forceps for coagulation in cases where hemostasis is not achieved. In clinical practice, the use of TDM-621 is expected to reduce the overall duration of ESD. For patients in the TDM-621 group in whom hemostasis was achieved, the operator's opinion was that the use of TDM-621 weakened the bleeding momentum and made it easier to identify the bleeding site. Consequently, TDM-621 might have contributed to the reduction in the number of coagulations even when hemostasis was not achieved.TDM-621 has been available for use in preventing intraoperative ESD and post-ESD bleeding in the colon in 28 countries, including the United Kingdom, Germany, France, and Italy, since 2014, and was approved for use in Canada in 2019. In 2021, the US Food and Drug Administration approved this solution as a hemostatic agent. In Japan, TDM-621 has been found effective in achieving hemostasis in 25 patients who underwent cardiovascular surgery (The incidence of AE was not significantly different between the TDM-621 and control groups. No defects derived from TDM-621 treatment were observed. No AE requiring discontinuation of the clinical trial or leading to death occurred. These findings confirm the safety of using TDM-621 for the treatment of blood oozing occurring during ESD, which had been established in previous clinical trials (This study has several limitations. First, the trial was not double-blind because the purpose of this study was to compare the hemostatic methods. Second, the study targeted only blood oozing and did not include blood spurting. It may be difficult for TDM-621 to completely stop the latter. However, based on our experience, we believe a coagulation hemostat would stop blood spurting because the bleeding site would be easily identified. In addition, it may be possible to reduce blood spurting with TDM-621 (In conclusion, TDM-621 was shown to be a useful hemostatic peptide with easy operability and no crucial technical and safety problems in the endoscopic treatment of gastric and rectal tumors. We expect that TDM-621 alone will be applied to a wide range of clinical fields as a hemostatic agent in the future. | PMC9889198 |
Supplementary Material | PMC9889198 | |||
Study Highlights | PMC9889198 | |||
WHAT IS KNOWN | tumor, intraoperative bleeding | TUMOR, INTRAOPERATIVE BLEEDING |
✓ Intraoperative bleeding occurs commonly with tumor resection, especially during rectal and gastric endoscopic submucosal dissection (ESD).✓ Management of intraoperative bleeding with hemostatic forceps is crucial to the success of ESD.✓ TDM-621, a synthetic, self-assembling peptide derived from nonliving sources, may help with hemostasis. | PMC9889198 |
WHAT IS NEW HERE |
✓ The number of coagulations with hemostatic forceps was significantly reduced in those who received TDM-621 in this trial.✓ Hemostasis was achieved with TDM-621 alone in 62% of patients. | PMC9889198 | ||
REFERENCES | PMC9889198 | |||
1. Introduction | TNF-α, Psoriasis, hyperplasia, hereditary predisposition, Tumor necrosis, psoriasis | INFILTRATION, PSORIASIS, HYPERPLASIA, PROLIFERATION, INFLAMMATION, INFILTRATES, PSORIASIS, TUMOR NECROSIS, INFLAMMATORY SKIN DISEASE, PATHOGENESIS | These authors contributed equally to this work.Psoriasis is a chronic inflammatory skin disease with autoimmune pathological characteristics. Recent research has found a link between psoriasis, inflammation, and gut microbiota dysbiosis, and that probiotics and prebiotics provide benefits to patients. This 12-week open-label, single-center clinical trial evaluated the efficacy of probiotics (Psoriasis is a chronic inflammatory skin disease with a significant hereditary predisposition and autoimmune pathological characteristics [The pathogenesis of psoriasis is characterized by uncontrolled proliferation and dysfunctional differentiation of keratinocytes. Histologically, psoriatic plaques show epidermal hyperplasia overlying inflammatory infiltrates of dermal dendritic cells, macrophages, T cells, and neutrophils. Tumor necrosis factor-α (TNF-α), interferon-γ (IFN-γ), interleukin (IL)-23/IL-17A, and IL-22 are the primary immunological molecules responsible for keratinocyte proliferation, inflammation, and cytokine infiltration in psoriasis [Probiotic supplementation could represent a novel therapeutic strategy in the treatment of gut microbiota dysbiosis in patients with psoriasis, as supplementation has been associated with significant alleviation of psoriasis-like pathogenic characteristics and a reduced proinflammatory status, in both experimental and clinical trials [ | PMC10342574 |
2. Results and Discussion | PMC10342574 | |||
2.2. PASI, DLQI, and Anthropometric Measures | FM | As presented in Although we observed no significant difference between the two groups in terms of fat mass (FM) changes ( | PMC10342574 | |
2.3. Inflammatory Markers | psoriasis | PSORIASIS | The effects of probiotic and prebiotic supplementation on inflammatory markers are presented in The association between probiotic supplementation in patients with psoriasis and changes in inflammatory markers is yet an active research field, but preliminary findings have revealed promising effects [ | PMC10342574 |
2.4. Metabolic Parameters | metabolic syndrome, low-density lipoprotein (LDL)-C | METABOLIC SYNDROME | After adjusting the cholesterol level results for sex, age, and baseline values, our results showed a significant difference between groups in total cholesterol (C), low-density lipoprotein (LDL)-C, and high-density lipoprotein (HDL)-C (Our study demonstrated that probiotic and prebiotic supplementation for 12 weeks resulted in a significant decrease in uric acid (In contrast to findings that showed an improvement in metabolic syndrome markers after probiotic supplementation [ | PMC10342574 |
2.5. Ultrasound Assessments | psoriasis | PLAQUE, PSORIASIS | Using the data generated from the high-frequency ultrasonography of psoriatic skin, we found significant differences in psoriasis plaque hydration, perilesional area hydration, and subepidermal low-echogenic band (SLEB) between the two groups ( | PMC10342574 |
2.6. Gut Microbiota Changes | psoriasis | PSORIASIS | After 12 weeks of probiotic and prebiotic supplementation, we identified 12 markers that differed significantly from baseline, including changes in seven bacterial abundances (The Shannon index is a parameter used to assess gut microbiota bacterial diversity, with higher values signifying greater community diversity [Because of its importance in maintaining intestinal homeostasis, the Gut microbiota dysbiosis, which is common in patients with psoriasis [ | PMC10342574 |
2.7. Limitations | This study had several limitations that should be considered when interpreting the results. First, due to the relatively small sample size ( | PMC10342574 | ||
3. Materials and Methods | PMC10342574 | |||
3.1. Ethical Considerations | This study was conducted according to the guidelines outlined in the Declaration of Helsinki, the Amsterdam Protocol, and Directive 86/609/EEC. The study protocol was approved by the Ethical Commission of the “Iuliu Haţieganu” University of Medicine and Pharmacy Cluj-Napoca (No. 267/06.30.2021). Prior to enrollment, all patients provided written informed consent to participate in the study. | PMC10342574 | ||
3.3. Data Collection | psoriasis | BLOOD, PSORIASIS | Background demographic and psoriasis diagnosis data were collected at the screening visit. Blood was collected at the beginning (screening visit) and end (Week 12) of the study. Levels of serum TNF-α, IL-6, IFN-γ, IL-17A, IL-10, and insulin were determined using commercially available enzyme-linked immunosorbent assay kits according to the manufacturer’s protocol (Elabscience, Houston, TX, USA). Total cholesterol, triglyceride, HDL-C, blood glucose, and uric acid levels were analyzed using an Indiko Plus Chemistry Analyzer (Thermo Fisher Scientific, Waltham, MA, USA). For the LDL-C determination, the following formula was used: ([total cholesterol − HDL] − triglyceride)/5. A previously described high-frequency ultrasonography technique was used for skin examinations [ | PMC10342574 |
3.4. Statistical Analysis | For normally distributed data, the mean and SD are reported; median and IQR are reported for non-normally distributed data. The paired-samples t-test and related-samples Wilcoxon signed rank test were used to detect differences among patients within the same group (i.e., from baseline to Week 12). Data from the intervention and control groups were compared using Pearson’s chi-square test. Between-group differences were analyzed using the independent-samples t-test and the independent-samples median test. An analysis of covariance (ANCOVA) test, adjusted for age, sex, and the baseline value of the parameter being evaluated, was used to compare the post-intervention final results. A | PMC10342574 | ||
4. Conclusions | psoriasis | INFLAMMATION, PSORIASIS | According to our findings, probiotic and prebiotic supplementation enhanced the general health of patients with psoriasis who were receiving local anti-psoriatic treatment. First, probiotic and prebiotic supplementation significantly improved quality of life, as demonstrated by a reduction in PASI and DLQI scores. Second, the BMI and FFM of patients in the intervention group were significantly reduced (end of trial versus baseline). Third, prebiotic and probiotic (Overall, our study showed that spore-based probiotic and precision prebiotic supplementation in patients with psoriasis who were receiving adequate anti-psoriatic therapy experienced multiple improvements, including improvements in quality of life, inflammation, and gut microbiota dysbiosis. However, additional clinical trials are needed to fully elucidate the potential benefits of probiotics and prebiotics for psoriasis and to identify the most effective combination and dose. | PMC10342574 |
Author Contributions | Conceptualization, M.C.B., R.C., D.M., A.B. and A.C.; methodology, M.C.B., L.I.G. and A.B.; supervision, L.I.G., D.M. and A.C.; writing—original draft, M.C.B. and R.C.; writing—review and editing, L.I.G. and A.T. All authors have read and agreed to the published version of the manuscript. | PMC10342574 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the “Iuliu Haţieganu” University of Medicine and Pharmacy Cluj-Napoca (No. 267/06.30.2021). | PMC10342574 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10342574 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy and ethical considerations. | PMC10342574 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10342574 | ||
References | tumor necrosis | TUMOR NECROSIS | Abundances that showed a significant difference (Design and flow of the study.Background characteristics.* Pearson’s chi-square test. ** Independent-samples DLQI and PASI comparison between the intervention and control groups.* Paired-samples Anthropometric data comparison between the intervention and control groups.* Paired-samples Inflammatory marker comparison between the intervention and control groups.** Related-samples Wilcoxon signed rank test. **** Independent-samples median test. IFN, interferon; IL, interleukin; IQR, interquartile range; TNF, tumor necrosis factor.Metabolic parameter comparison between groups.* Paired-samples Changes in skin ultrasound markers.* Related-samples Wilcoxon signed rank test. ** Independent-samples median test. IQR, interquartile range; SLEB, subepidermal low-echogenic band.Key changes in normally distributed parameters of gut microbiota.* Paired-samples Key changes in non-normally distributed parameters of gut microbiota.* Related-samples Wilcoxon signed rank test. IQR, interquartile range | PMC10342574 |
Subject terms | SCES, cord injury, torques | SECONDARY | Two persons with chronic motor complete spinal cord injury (SCI) were implanted with percutaneous spinal cord epidural stimulation (SCES) leads to enable motor control below the injury level (NCT04782947). Through a period of temporary followed by permanent SCES implantation, spinal mapping was conducted primarily to optimize configurations enabling volitional control of movement and training of standing and stepping as a secondary outcome. In both participants, SCES enabled voluntary increased muscle activation and movement below the injury and decreased assistance during exoskeleton-assisted walking. After permanent implantation, both participants voluntarily modulated induced torques but not always in the intended directions. In one participant, percutaneous SCES enabled motor control below the injury one-day following temporary implantation as confirmed by electromyography. The same participant achieved independent standing with minimal upper extremity self-balance assistance, independent stepping in parallel bars and overground ambulation with a walker. SCES via percutaneous leads holds promise for enhancing rehabilitation and enabling motor functions for people with SCI.Percutaneous spinal cord epidural stimulation (SCES) leads were implanted in two men with spinal cord injury (SCI) in an approved trial by the McGuire IRB committee. SCES decreased the assistance required from the exoskeleton. In one participant, SCES enabled standing and stepping in parallel bars and overground ambulation with a walker. | PMC10091329 |
Introduction | SCES, cord injury | SPINAL CORD | Spinal cord epidural stimulation (SCES) may modulate spinal cord neural networks to enhance multiple functions after motor complete spinal cord injury (SCI)This case report describes early results of two persons with clinically sensory-motor complete and a motor complete SCI enrolled in a clinical trial investigating the effects of percutaneous SCES for motor function (NCT04782947; IDE# G190003). Further details are provided in a timeline of study procedures (Fig. | PMC10091329 |
Study timeline. | SCES, EAW | Timeline of study phases for NCT04782947. After baseline outcome measures are assessed, temporary implantation occurs followed by 5 days of mapping. After removal of the temporary implant, participants are given 2 weeks rest and then receive the permanent implant. Permanent implant mapping occurs for 2 weeks, focusing mainly on voluntary limb movement and extensor activity to facilitate standing. Following this, phase I of the study begins, consisting of 24 weeks training 3 days per week. Each training day consists of one hour of spinal cord epidural stimulation (SCES) combined with exoskeleton-assisted walking (EAW), followed by one hour of SCES combined with standing task-specific training (StTST). After 1 week of re-assessing outcome measures (Post-assessments 1), 4 weeks of re-mapping is conducted to optimize standing, and walking function for the next phases of the study. Following this, phase II of the study begins, consisting of 24 weeks of the same training as phase I. In the final week of the study, outcome measures are re-assessed a final time (post-assessments 2). | PMC10091329 | |
Results | PMC10091329 | |||
Participant characteristics | Spinal Injury Association Impairment Scale [, traumatic SCI | Two men with clinically motor complete traumatic SCI (C8; 6 years post-injury [ID#: 0772] and T11; 9 years post-injury [ID#: 0773]), American Spinal Injury Association Impairment Scale [AIS] A and B, respectively) participated in a trial approved by the Hunter Holmes McGuire Veteran Affairs Medical Center ethical IRB committee. AIS exam sheets for both participants and magnetic resonance images for 0772 are provided in Supplementary Figs. | PMC10091329 | |
Temporary and permanent implantation | SCES | Both participants underwent temporary SCES implantation (5 days) followed by permanent implantation 4 weeks later (Supplementary Figs. | PMC10091329 | |
Spinal mapping | Spinal mapping was carried out to identify optimal configurations (cathodal-anodal electrode arrangements and stimulation parameters) to enable multiple functions and movements without inducing unwanted activity | PMC10091329 | ||
Supine rhythmic EMGs. | SCES | Example electromyograms (EMGs) of left leg muscles (black traces) and right leg muscles (gray traces) while SCES is delivered in supine at various amplitudes to participant 0773, using the configuration shown on the left of the figure (black is the cathode and the red is the anode). In the left column of EMGs, SCES delivered at 5.2 mA induces little tonic activity or no activity at all. In the right column of EMGs, the same SCES configuration is delivered at 5.4 mA. Upon ramping of stimulation to 5.4 mA, a single burst of activity across all muscles is induced, followed by periods of relaxation and then subsequent bursts of similar shape. Each burst of muscle activity across all muscles resulted in sudden, bilateral knee, hip and ankle flexion, followed by the legs returning to resting on the table during periods of relaxation. EMGs presented are rectified and bandpass filtered at 10–990 Hz. L left, R right, VM vastus medialis, RF rectus femoris, TA tibialis anterior, HS hamstring, MG medial gastrocnemius, GM gluteus medius, mV millivolts, mA milliamps, Hz hertz, µs microseconds, sec seconds. | PMC10091329 | |
Voluntary motor activity | SCES, voluntary movements | Participant 0772 did not elicit intentional voluntary movements in supine or side lying positions. His legs moved in response to different SCES configurations following temporary implantation. On day 1 of temporary mapping, in the presence of percutaneous SCES, 0773 voluntarily flexed his right hip from a side lying position on command (Supplementary Fig. | PMC10091329 | |
Configuration for 0773 resulting in right leg flexion. | knee extension | Left leg muscles are depicted in black and right leg muscles in gray. Both plots occurred simultaneously but have been separated to better visualize different effects of voluntary effort between legs. At 1.3 mA, bilateral muscle activity was induced. However, when the participant volitionally attempted to flex his right leg, muscle activity decreased in some left leg muscles (VL, RF, and HS) while increasing or bursting in right leg muscles (RF, TA, HS, and MG). Hz hertz (stimulation frequency), µs microseconds, L left, R right, VL vastus lateralis, RF rectus femoris, TA tibialis anterior, HS hamstrings, MG medial gastrocnemius, sec seconds, µv microvolts.The participants’ ability to volitionally generate isometric knee extension torque in a seated position was tested using the configurations that induced or enabled knee extension in supine. Testing took place 12 weeks (0772) or 5 weeks (0773) after permanent implantation. Detailed peak voluntary torque methods are described in the | PMC10091329 | |
Standing ability | SCES | In the first phase of the study, with SCES on, 0772 did not need to use his upper extremities for balance self-assistance in a standing position. In contrast when SCES was off, he needed to hold the parallel bars and use his upper extremities to self-assist balance. However, 0772 required maximal knee assistance and moderate hip assistance from study staff to stand in parallel bars whether SCES was on or off, and this persisted throughout the whole study. Despite this, during the interim mapping process (following the first phase of the study) when configurations for standing were refined, 0772 demonstrated volitional trunk and hip control while in a semi-standing position, supported in the standing frame; further details are provided in Fig. | PMC10091329 | |
Voluntary hip flexion and extension with trunk control (participant 0772) from a semi-standing position in a standing frame. | Panels | PMC10091329 | ||
0772 Exoskeleton sit-to-stands. | Electromyograms (EMGs) of lower extremity muscles of 0772 during active attempts to complete a sit-to-stand maneuver with the exoskeleton in “Squat” mode. In this mode, the exoskeleton will not passively complete a sit-to-stand for the user; rather, assistive torque is provided at the knees and hips which can enable the user to complete a sit-to-stand only if they are able to volitionally contribute to the movement. The assistance level was set to “very high”, which is the highest of four levels of manufacturer-determined assistance. | PMC10091329 | ||
0773 overground standing. | Electromyograms (EMGs) of lower extremity muscles of 0773 during overground standing in parallel bars. | PMC10091329 | ||
Exoskeleton-assisted walking and overground stepping | Using the aforementioned mapping procedures in the interim period, configurations for rhythmic activity did not yield locomotor-like muscle activity in supine position in that the bursting was synchronous across all muscles in both legs (i.e. lack of a reciprocal relationship between antagonistic muscles or left-right alternations; Fig. | PMC10091329 | ||
EAW enhancement figure. | EAW | Data points showing changes in exoskeleton-assisted walking (EAW) performance for two participants walking in “Adaptive” mode, a manufacturer setting which adjusts the amount of assistance provided to the user, and thus can result in variability in certain parameters of gait. | PMC10091329 | |
EAW enhancement EMG figure. | SCES, EAW | Example electromyograms of one participant (0773) during exoskeleton-assisted walking (EAW) without or with spinal cord epidural stimulation (SCES). Left leg muscles are shown in black, right leg muscles are shown in gray. Without SCES, very little muscle activity occurs through the gait cycle, mainly in the right hamstring and medial gastrocnemius muscles, which occurred during the swing phase of the left leg. With SCES on, using the same configuration that resulted in rhythmic bursting in supine as seen in Fig. | PMC10091329 | |
Discussion | muscle mass, exoskeleton-provided, reduced exoskeleton-provided, flexion or extension torques, knee flexion, hip flexion, SCES, chronic motor complete SCI | Percutaneous SCES enabled motor control in two persons with chronic motor complete SCI. Both participants could also volitionally modulate induced flexion or extension torques on verbal instruction in a seated position. One participant (0773) initiated hip flexion, knee flexion, and ankle dorsiflexion in a supine lying position following temporary and permanent implantation. The other participant (0772) did not show an immediate ability to volitionally generate movement or EMG activity; however, he was able to voluntarily modulate SCES-induced torque after the permanent implantation, and following interim mapping, demonstrated volitional hip and trunk control when supported in a semi-standing position. Standing configurations in 0772 may have resulted in trunk muscles modulation via inter-neuronal connections with lower lumbosacral segments, which resulted in enhanced trunk control as seen in Fig. Both participants demonstrated improved standing ability via execution of a volitional sit-to-stand with exoskeleton assistance (0772) or unassisted standing in parallel bars (0773). It is possible that the muscle activity during these activities (Figs. In participant 0773, we cannot rule out that his standing ability is related to load receptor augmentation, rather than him enabling volitional motor control, that resulted in amplification of extensor tone to sustain standing (Fig. Both participants showed increased muscle activity during EAW concurrent with enhanced EAW performance, indicated by faster walking speeds with reduced exoskeleton-provided swing phase assistance. The increased muscle activity manifested mainly as increased EMG amplitudes during the stance phase of gait as opposed to more typical patterns of alternating firing of flexors and extensors during the swing phase. The atypical EMG firing observed during EAW (without SCES) is driven primarily by the exoskeleton-provided flexion and extension patternThere are several possible reasons for the discordant results between participants. The first explanation may be differing injury levels, injury severity (AIS A or AIS B), or differences in preserved muscle mass. Previous studies have also shown position-dependent effects of SCESThese factors notwithstanding, it is likely that SCES (afferent excitation) combined with the participants’ intention to move (supraspinal control) enabled movement in varied contexts for both participantsCurrently, our registered clinical trial is scheduled to recruit 20 participants. Recruiting, implanting, and training more participants will need additional time. Furthermore, our research center is working hard within the COVID-19 precautions to ensure reasonable flow without exposing research staff or patients to additional unnecessary risks. We are reporting results on our first two participants as an interim report to demonstrate the feasibility of our research protocol and to ensure timely dissemination within the SCI community.In summary, the current report shows percutaneous SCES may enable motor control leading to functional improvements not possible with SCES off. Relatively simple mapping procedures and configurations were used to enhance performance of rehabilitation and training sessions. With these same configurations, some functional benefits manifested without the need for extensive training, such as standing with minimal use of upper extremity and stepping with a walker in one participant. It is possible that the severity of the injury, preserved muscle mass, and the accuracy and position specificity of the spinal mapping may have played a role in the findings of the current report. Further work is needed to refine mapping and training protocols to ensure optimization of this enabled motor control, and to make results more consistent across participants. Future research should investigate the efficacy of percutaneous SCES in combination with physical rehabilitation for restoration of motor control in large cohorts of persons with chronic SCI. | PMC10091329 | |
Methods | PMC10091329 | |||
Subjects | Spinal Injury Association Impairment Scale [, traumatic SCI | Two men with clinically motor complete traumatic SCI (C8; 6 years post-injury [ID#: 0772] and T11; 9 years post-injury [ID#: 0773]), American Spinal Injury Association Impairment Scale [AIS] A and B, respectively) participated in a trial approved by the Hunter Holmes McGuire Veteran Affairs Medical Center ethical IRB committee. AIS exam sheets for both participants and magnetic resonance images for 0772 are provided in Supplementary Figs. | PMC10091329 | |
Inclusion and exclusion criteria | flexion knee contractures, neurological injury, traumatic motor complete SCI, scoliosis, areflexia, fracture, contracture, −3.5, ’ knee extensors, cardiovascular problems, Spinal Injury, cauda equina | UNCONTROLLED HYPERTENSION, TYPE II DIABETES MELLITUS, CARDIOVASCULAR DISEASE, SCOLIOSIS, ORTHOSTATIC HYPOTENSION, URINARY TRACT INFECTION | Participants may be included if they are between 18 and 60 years old, male or female, with traumatic motor complete SCI and level of injury of between C5 to T10, as determined the International Standards for Neurological Classification of SCI (ISNCSCI) exam. Participants’ knee extensors must respond to standard surface NMES procedures (frequency: 30 Hz; pulse duration: 450 µs and amplitude of the current: up to 200 mA) to ensure intact neural circuitry below the level of SCI. All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included. The inclusion of AIS A and B ensures we can simply detect any additional volitional control below the motor level of injury. A caregiver or companion must be available to assist subjects who require assistance. We have chosen to set the age limit to 60 years as the upper limit of the study, because persons above 60 years old are likely to have cardiovascular problems that can prevent engagement in strenuous physical activity for 12 months. A written clearance by the medical doctor to ensure that the participant was safely able to engage in the program. Women on contraceptives may be included in the study.Participants may be excluded from the current trial if any of the following pre-existing medical conditions are present: (1) Diagnosis of neurological injury other than SCI, including cauda equina or distal conus injuries resulting in limb or sacral areflexia; (2) Unhealed fracture in either lower or upper extremities; (3) Severe scoliosis, hip knee range of motion (ROM) or flexion knee contractures preventing positioning in an exoskeleton or plantarflexion contracture >20°. (4) Untreated or uncontrolled hypertension defined as high resting blood pressure >140/90 mmHg and severe orthostatic hypotension (drop greater than 20 mmHg compared to resting supine blood pressure) or incapable to maintain a sitting or EAW standing posture; (5) Other medical conditions including cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, or symptomatic urinary tract infection; (6) Unable to fit in the device for any reason; (7) Taking anti-coagulants or anti-platelet agents, including aspirin if unable to be off this medication for medical reasons; (8) Implanted pacemakers and/or implanted defibrillator devices; (9) DXA T-Score <−2.5 standard deviations of the total body. Total hip bone mineral density (BMD) T-scores <−3.5 and knee BMD scores of less than 0.6 g/cm | PMC10091329 |
Magnetic resonance imaging | Prior to enrollment in the trial, participants were asked to conduct magnetic resonance image (MRI; T2 Turbo Spin Echo with long band width; SIEMENS 1.5T) with the following scanning sequence (slice thickness: 3 mm, TR: 9350, TE: 102; flip angle: 150) for pre-screening purpose. MRI was conducted to verify the injury site and determine the extent of injury (Supplementary Fig. | PMC10091329 | ||
Interventions | PMC10091329 | |||
Implantation of epidural stimulation | SCES, pain | EVENTS, ENLARGEMENT | This is a 2-step process where temporary implantation precedes permanent implantation when indicated. The SCES system (Intellis Epidural Stimulator, Medtronic, Minneapolis, USA) was used to electrically stimulate the lumbosacral enlargement. During temporary implantation, two 8-electrode lead arrays were implanted utilizing fluoroscopic guidance over spinal cord segments T10-L2. Prior to both temporary and permanent procedures Hibiclens® (chlorhexidine) soap skin cleanser and Bactroban® (mupirocin) 2% ointment is given for 7 days prior to the procedure to reduce bacterial colonization of participant’s skin and nares. An anesthesia preoperative evaluation was performed, and consent obtained prior to entrance into the operating room. We have split the process of implantation into temporary and permanent to ensure appropriate placement of the leads. Additionally, possible unanticipated medical events may emerge following temporary implantation that may lead to withdrawal from the study or to be considered as a screen failure or the patient may deny participation because feeling of discomfort or pain. | PMC10091329 |
Temporary implantation | MINOR | Participants were scheduled to perform the temporary implantation. After placing the participant in a prone position, the participant was implanted in a minor procedure room under fluoroscopy guidance. A nurse certified in sedation established IV access, place standard ASA monitors including noninvasive blood pressure every 5 min, pulse oximetry, continuous EKG, and end tidal CO | PMC10091329 | |
Permanent implantation | pain | STERILE | Fourteen days following temporary implantation, two 8-electrode arrays of Vectris lead were implanted in an operating room (see the listed details about the Intellis System). The trial was undertaken in a sterile environment with the presence of a representative. Phase 1 of the permanent implantation is identical to the temporary trial described but with the anesthesia provided by an anesthesiologist. An IV line was established and standard ASA monitors was placed including noninvasive blood pressure every 5 minutes, pulse oximetry, continuous EKG, and end tidal COPrescription for pain medicine was only for 3 days as this seems to be the most painful part as the single incision heals. Recovery after implant was complete at the 7–10 days mark when bandages were removed. Participants were examined 3 times in the first month for wound check (1 week), dressing change (1 week and 2 week) and reprogramming (week 4). Permanent implantation was followed with 3–4 weeks of instruction not to perform strenuous physical activities without immobilization, during which spinal mapping took place in week 4. Rostro-caudal and medio-lateral migration of the leads were evaluated following both temporary (5 days post-impanation) and permanent implantation. | PMC10091329 |
The Intellis system has two main sets of components | fits, ® | STERILE, PAD |
External components for IntellisModel 97715/97716 Wireless External NeurostimulatorThe Medtronic Model 97715/97716 Wireless External Neurostimulator (ENS) is part of a neurostimulator system used for intraoperative testing during lead placement and for trial stimulation outside of the operating room. The Medtronic Model 97715/97716 Wireless External Neurostimulator is a disposable, sterile, single-use device equipped with BLUETOOTH® wireless technology.Model 97745 Patient ControllerThe controller is a hand-held device that allows to turn the neurostimulator on and off and check the neurostimulator battery status. It is also used to adjust some of the stimulation settings.Model 375003 Boot for Wireless External NeurostimulatorThe external neurostimulator boot is a nonsterile, single-use accessory used to secure the Model 97725 Wireless External Neurostimulator to Participant ‘s skin with an adhesive pad during trial stimulation.Model 97755 RechargerThe Medtronic Model 97755 Recharger is designed to charge Medtronic rechargeable neurostimulator.Model 8880T2 CommunicatorThe Model 8880T2 Communicator is intended for use by clinicians to use in conjunction with the clinician tablet and clinician programmer app for communication with Medtronic neuromodulation medical devices.The communicator is handheld and battery-operated. Communication between the communicator and a clinician tablet can occur wirelessly using BLUETOOTH® technology or wired using the USB connector cable.Implanted components for Intellis:Model 977D260 Vectris™ 1 × 8 Compact Trial Screening Lead KitThe Medtronic Vectris 1×8 Compact Model 977D260 Trial Screening Leads is part of a neurostimulator system. The lead has electrodes on the distal end; the proximal (connector) end fits into an 8-conductor connector. A stylet has been inserted into the proximal end of the lead to aid in positioning. | PMC10091329 |
Spinal segmental mapping | SCES, lower extremity muscle | RECRUITMENT, CONTRACTION, RECRUITMENT | Following both temporary and permanent implantation, participants were scheduled to perform the process of spinal segmental mapping. Spinal mapping is the process of identifying the right stimulation parameters (frequency, amplitude, and pulse duration) responsible for activation of the lower extremity muscle groups, polarity of the electrodes (cathodes vs. anodes), as well as the number of the channels responsible to evoke the desired contraction and joint movement pattern (hips, knees, and ankles). The mapping protocol may require stimulation for every specific muscle group and joint per each limb.Spinal mapping was carried out to identify optimal configurations (cathodal-anodal electrode arrangements and stimulation parameters) to enable multiple functions and movements withoutinducing unwanted activityFrom supine position, 12 EMG sensors were attached (left and right vastus medialis, rectus femoris, tibialis anterior, medial hamstring, medial gastrocnemius, and gluteus medius) after shaving and carefully cleaning the skin. The participant was then asked to make three major movements such as wiggling the big toe, dorsiflexion of the ankle joint or moving the entire leg into flexion followed by extension. We aimed to find a multiple electrode combination with the correct stimulation parameters to identify SCES configurations for standing, SCES-evoked recruitment curves from 5 standardized SCES configurations were established based on EMG peak-to-peak amplitude of each muscle group. Recruitment curves were collected by stimulating at 2 Hz from 1–10 mA; three recruitment curves were collected for each configuration at pulse widths of 250, 500, or 1000 µs. From these curves, optimum stimulation configurations that could yield tonic extensor activity for standing were determined. These optimum stimulation configurations were re-tested in a standing frame or standing with a standard walker to establish the standing configurations. Participants were then trained on how to use the SCES controller to activate paralyzed lower extremity muscles.The emphasis of the first 6 months of the study was to achieve overground standing, while the emphasis of the second 6 months was to achieve step-like activity to lead to overground ambulation. Thus, the initial temporary and permanent mapping periods prior to the first 6 months emphasized voluntary limb movement and extensor activity to facilitate overground standing.In the interim mapping phase, these original configurations were refined. Configurations which yielded tonic extensor activity in supine were refined to enable standing with the participant upright, first fully supported in a standing frame. Further refining was done by having participants attempt a sit-to-stand in an exoskeleton (EksoNR, Ekso Bionics, CA, USA) in “squat” mode, a manufacturer setting which provides assistive torque at the knees and hips sufficient to complete a sit-to-stand only if the user volitionally contributes to the movement. Lastly, configurations were refined with participants standing in parallel bars. In addition to refinement of configurations for standing, during the interim mapping phase, further mapping was conducted for rhythmic locomotor activity to facilitate stepping and overground ambulation. Different SCES configurations were tested at 2 Hz and 210 µs with incremental amplitudes to see which configurations preferentially recruited the vastus medialis muscles over the medial gastrocnemius muscles at lower amplitudes | PMC10091329 |
Exoskeleton assisted walking | AUTONOMIC DYSREFLEXIA | Prior to training, a research assistant helped to fit the participant into the device starting with the shoes-support (distally) and then going up toward the trunk (proximally). The software was adjusted and progressed based on the need of each participant. Every effort was made to ensure that all straps were snug but not excessively tight to avoid any episode of autonomic dysreflexia. EAW was scheduled either in the morning or in the evening 3 days/week for the duration of the study. Participants used pro-step+ mode starting with a standard roller walker and then to Canadian Crutches in approximately 4 weeks. The unit is equipped with two buzzers that helps cueing the participants to accurately complete weight shifting prior to stepping | PMC10091329 | |
Progression to the adaptability mode | EAW | This mode allows the exoskeleton to gradually lower the assistance provided to the participant based on their performance. In the adaptive assistance mode, the support ranges from 0 to 100%, with 100% means that the unit provides 100% support and assistance to ambulate. During sessions, SCES was turned on and we started with 100% assistance and dropped the support by 5–10% increments each week as tolerated until we reach the lowest assistance level possible during EAW. Decision to drop the assistance will be based on the subject’s ability to complete 80% (i.e. arbitrary threshold | PMC10091329 | |
Overground standing and ambulation without exoskeleton | Following the exoskeleton session, a follow-up-visit on the same day was conducted to provide over ground standing and walking experience. This started by allowing the subject to stand-up in a standing frame or between parallel bars and to do stepping for 10 feet assisted by a trained researcher. If the subject manages to control standing and stepping between the standing frame or parallel bars, they progressed to perform guarded and supervised walking with a therapist and research assistant for 50 feet using a standard roller walker. | PMC10091329 | ||
Measurements | PMC10091329 | |||
Surface EMGs | After standard skin preparation, surface EMGs were used to record lower extremity and/or trunk muscles, depending on the task being tested. Muscles assessed for mapping and voluntary movement testing included bilateral vastus medialis, rectus femoris, tibialis anterior, hamstring, medial gastrocnemius, and gluteus medius. Muscles assessed for voluntary trunk and hip extension in semi-standing included bilateral medial hamstrings, vastus lateralis, gluteus medius, transverse abdominis, erector spinae at the level of the T10 vertebrae, and erector spinae at the level of the T5 vertebrae. All EMGs were collected at a 2000 Hz sampling rate using LabChart 8.1.21 (Windows)- ADInstruments. EMGs show in figures are rectified with a 10–990 Hz bandpass filter. In some instances, a root-mean-square filter was layered overtop of the original filtering with a 100-sample window. | PMC10091329 | ||
Exoskeleton-assisted walking performance | Exoskeleton-assisted walking performance variables - steps per minute, step length, and minimum assistance – are derived from data collected by the exoskeleton itself, and then automatically uploaded to the company’s online clinical database. Step length and minimum assistance are provided for each individual leg, whereas steps per minute provides the average number of steps per minute taken by both legs for each minute of walking. Step length and minimum assistance values from the left and right legs were averaged to yield one value for each variable, per each step taken by the exoskeleton. Exoskeleton-assisted walking performance values reported represent the average values across 300 steps per session – 5 sessions of exoskeleton-assisted walking values using limb movement SCES are presented next to 5 sessions using rhythmic activity SCES in Fig. | PMC10091329 | ||
Overground ambulation | During post-interventions 1 and 2, overground ambulation without wearing the exoskeleton was tested using parallel bars over a 10-feet (3.05 m) walking distance. | PMC10091329 | ||
Peak isometric torque | SCES | This was evaluated using a Biodex isokinetic dynamometer (Shirely, NY). Participants were seated with both the trunk-thigh angle and the knee-thigh angle at 90°. After transferring using a ceiling lift, each participant was securely strapped to the test chair by a crossover shoulder harnesses and a belt across the hip joint. The axis of the dynamometer was aligned to the anatomical knee axis and the lever arm was attached 2-3 cm above the lateral malleolus. Isometric peak torque was measured after implantation, with SCES on and SCES off to allow comparison between the two conditions. Each participant was initially asked to kick his leg as strong as possible to measure the torque generated at the knee joint when the SCES is off and then after 2 minutes resting interval with SCES on. Torque data were collected at a 1000 Hz sampling rate and analyzed using LabChart 8.1.21 (Windows)- ADInstruments. | PMC10091329 | |
Reporting summary | Further information on research design is available in the | PMC10091329 | ||
Supplementary information |
Supplementary InformationPeer Review FileReporting Summary | PMC10091329 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41467-023-37845-7. | PMC10091329 | ||
Acknowledgements | DoD-CDMRP | The work is currently supported by the DoD-CDMRP clinical trial program award number # W81XWH-20-1-0845 (SC190107 CDMRP W91ZSQ) and Department of Veteran Affairs-SPiRE Program (B3456-P). We would like to thank Center for Rehabilitation Science Engineering Centre-VCU (Ronald Seel, PhD & David Cifu, MD) for providing scientific support to our work. The sponsors did not have any role in study design, data collection and analysis or manuscript writing. | PMC10091329 | |
Author contributions | SCES, T.D.L. | A.S.G., D.L., and R.T initiated the project and designed the study protocol. L.L.G. and T.D.L. performed clinical assessments. R.T. Intraoperative placement of the SCES and subjects’ assessment. A.S.G., T.W.S., J.A.G., and A.A. contributed to data collection, analysis, and interpretation and drafted the manuscript with subsequent contribution from all authors. T.W.S, J.A.G., and A.S.G. supervised all aspects of the work., A.S.G. secured funding | PMC10091329 | |
Peer review | PMC10091329 | |||
Data availability | De-identified data of the two participants will be available upon direct communication with the corresponding author and upon receiving approval from the appropriate research committee from the Department of Veteran Affairs immediately following publication and available for 3 years. Source data, study protocol and informed consent form are also included with the current submission and limited only for research use. | PMC10091329 | ||
Competing interests | The authors declare no competing interests. | PMC10091329 | ||
References | PMC10091329 | |||
Key Points | PMC9857469 | |||
Question | CVD | CVD, CARDIOVASCULAR DISEASE | What are the impacts of an entirely plant-based vs a low-fat, reduced–animal product omnivorous diet on changes in 12-month and 24-month body weight and lipids among African American adults at risk for cardiovascular disease (CVD)? | PMC9857469 |
Findings | CVD | In this randomized clinical trial of 159 adults, participants in both groups saw similar improvements in body weight and CVD risk factor outcomes. | PMC9857469 | |
Meaning | weight loss | CVD | Both plant-based and low-fat omnivorous soul food diets produced modest weight loss and CVD risk-related improvements among African American adults.This randomized clinical trial compares the effects of an entirely plant-based vegan or low-fat omnivorous diet on change in body weight and lipids during a 2-year intervention. | PMC9857469 |
Importance | CVD, chronic disease | CVD, CARDIOVASCULAR DISEASE, CHRONIC DISEASE | More African American individuals die from cardiovascular disease (CVD) than any other chronic disease condition. Despite this disparity, African American individuals are underrepresented in nutrition and CVD interventions. | PMC9857469 |
Objective | To compare the effects of an entirely plant-based (vegan) or low-fat omnivorous (omni) diet on change in body weight and lipids during a 2-year intervention. | PMC9857469 | ||
Design, Setting, and Participants | weight loss, overweight or obesity | TYPE 2 DIABETES, THYROID DISEASE | The Nutritious Eating With Soul (NEW Soul) study was a 2-year, randomized clinical trial conducted in 2 cohorts (2018-2020 and 2019-2021) that took place in a university teaching kitchen in Columbia, South Carolina (before March 2020), and via online videoconference sessions (after March 2020). Participants included African American adults aged 18 to 65 years with overweight or obesity (body mass index of 25.0-49.9) and without type 2 diabetes, uncontrolled thyroid disease, recent weight loss, or pregnancy. Data assessors and statisticians were blinded to study condition. Data analysis was performed from March to June 2022. | PMC9857469 |
Interventions | The intervention included weekly nutrition classes for 6 months biweekly classes for 6 months, and monthly classes for 12 months. Dietary interventions either emphasized no animal product intake (vegan) or a low-fat omnivorous diet (omni). Both dietary patterns emphasized soul food cuisine (traditional African American southern foodways). | PMC9857469 | ||
Main Outcomes and Measures | Primary outcomes included change in body weight and lipid measures at 12 months. | PMC9857469 | ||
Results | There were 568 participants who completed an online screening questionnaire; 409 were excluded and 159 were randomized (77 to the vegan group and 82 to the omni group). Of the 159 participants (mean [SD] age, 48.4 [10.6] years; 126 female [79%]) who began the study, the main outcome of body weight was obtained for 121 participants (76%) at 12 months. There were no differences in outcomes between groups, including 12-month changes in weight (mean, –2.39 kg [95% CI, –3.48 to –1.30 kg] for the vegan group vs –2.03 kg [95% CI, –3.07 to –1.00 kg] for the omni group; | PMC9857469 | ||
Conclusions and Relevance | weight loss | CVD | In this randomized clinical trial examining weight loss and CVD risk factor reduction among African American adults, there were no differences between the groups, and the magnitude of changes overall was small. | PMC9857469 |
Trial Registration | ClinicalTrials.gov Identifier: | PMC9857469 | ||
Introduction | overweight or obesity, CVD | CVD, CARDIOVASCULAR DISEASE, CHRONIC DISEASE | In the US, African American individuals die from cardiovascular disease (CVD) more than any other chronic disease.Although several studiesThe Nutritious Eating With Soul (NEW Soul) study, a 2-year behavioral nutrition intervention among African American individuals with overweight or obesity, was conducted to address the limited inclusion of African American individuals in nutrition interventions and limited prior intervention work examining the impact of a PBD on CVD risk factors. The intervention compared 2 diets, both emphasizing soul food cuisine: entirely PBD (vegan) or low-fat omnivorous (omni). The aim of this study was to compare the effects of each diet on the primary outcomes of change in body weight and lipids across the 2-year study, with the primary outcomes examined at 12 months and maintenance examined at 24 months. | PMC9857469 |
Methods | PMC9857469 | |||
Study Participants | The NEW Soul intervention, inclusion criteria, and measures have been described elsewhere. | PMC9857469 | ||
Measures | Measures for the NEW Soul intervention have been described elsewhere. | PMC9857469 | ||
Measures Assessed and the Time Points in the Nutritious Eating With Soul Study | PMC9857469 |
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