title
stringlengths
1
1.19k
keywords
stringlengths
0
668
concept
stringlengths
0
909
paragraph
stringlengths
0
61.8k
PMID
stringlengths
10
11
References
PMC10439640
Background:
Parkinson’s disease, PD
These authors contributed equally to this work.Axial symptoms of Parkinson’s disease (PD) can be debilitating and are often refractory to conventional therapies such as dopamine replacement therapy and deep brain stimulation (DBS) of the subthalamic nuclei (STN).
PMC10357146
Objective:
Evaluate the efficacy of bilateral DBS of the pedunculopontine nucleus area (PPNa) and investigate structural and physiological correlates of clinical response.
PMC10357146
Methods:
A randomized, double-blind, cross-over clinical trial was employed to evaluate the efficacy of bilateral PPNa-DBS on axial symptoms. Lead positions and neuronal activity were evaluated with respect to clinical response. Connectomic cortical activation profiles were generated based on the volumes of tissue activated.
PMC10357146
Results:
PPNa-DBS modestly improved (
PMC10357146
Conclusion:
PD
Bilateral PPNa-DBS influenced gait symptoms in patients with PD. Anatomical and physiological information may aid in localization of a favorable stimulation target.
PMC10357146
INTRODUCTION
Parkinson’s disease, gait disturbances, PD, axial motor symptoms
DISEASE PROGRESSION
Parkinson’s disease (PD) is generally well-managed by dopamine replacement therapy and/or deep brain stimulation (DBS) of the subthalamic nucleus (STN); however, axial motor symptoms can emerge with disease progression, including postural instability and gait disturbances. These features can result in falls and diminis...
PMC10357146
METHODS AND MATERIALS
PMC10357146
Patients
Seven patients were treated with bilateral PPNa-DBS within a controlled clinical trial. Patient information is available in Patient information
PMC10357146
Surgical procedures
Bilateral electrode implantations (3389 Model, Medtronic, MN, USA) were performed under local anesthesia after overnight withdrawal from anti-parkinsonian medication. The PPNa was targeted via direct localization using a proton-density MRI protocol at 1.5T [
PMC10357146
Therapy and stimulation parameters
The optimal stimulation parameters (
PMC10357146
Complications and side effects
ischemia, bleeding, transient motor aphasia
ISCHEMIA, BLEEDING, POSTOPERATIVE COMPLICATIONS
MRI images acquired postoperatively showed no abnormalities related to asymptomatic bleeding or ischemia. The following postoperative complications were documented: transient motor aphasia without a morphological MRI correlate and without indications for seizure-typical activity in EEG (
PMC10357146
Study design
micro-lesions
A prospective, randomized, double-blind, cross-over study design was applied with two 2-month treatment periods subsequent to a 2-month postoperative period (see Randomized double-blind cross-over study design. The patients were brought in for baseline evaluations preoperatively. The operation was followed by a two-mon...
PMC10357146
Outcome measures
Parkinson’s Disease Questionnaire (PDQ-39).
SECONDARY, COMPLICATIONS, MOS
Per the registered study protocol, the primary outcome was the “Axial-Score” (UPDRS items 13–15; falling unrelated to freezing, freezing when walking, walking; and 27–31; arising from chair, posture, gait, postural stability, body bradykinesia) comparison between Stim-ON and Stim-OFF, in the medication-OFF condition. A...
PMC10357146
Structural and functional connectomic profiles
In additional to structural imaging analyses in stereotactic space, DBS lead localizations were performed in Lead-DBS, as previously described in detail [
PMC10357146
RESULTS
PMC10357146
Trial outcomes
SECONDARY
Complete results including primary and secondary outcome measures and additional findings are available in
PMC10357146
Lead placements
Based on MRI analyses in stereotactic space, more anterior lead placements appeared to be favorable (A) Lead placement correlates, and B) single-unit recordings. A) MRI results suggest that more anterior lead placements were favorable. B) Single-unit recordings show two clusters of neurons (cluster-1 being faster and m...
PMC10357146
Microelectrode recordings
A correlation fit with a power function (
PMC10357146
Structural and functional connectomic profiles
PPNa-DBS leads were localized in Lead-DBS (Lead locations and groupwise structural and functional connectomic profiles. A, B) Reconstructions of all electrodes, C, D) fibers traversing the groupwise VTA, and E) structural and F) functional connectivity profiles.
PMC10357146
DISCUSSION
Bilateral PPNa-DBS modestly influenced axial features (particularly gait) in the medication-OFF condition. Only two other randomized clinical studies evaluated the efficacy of bilateral PPN-DBS without concurrent STN-DBS [The results of an open-label study (Other double-blind studies which applied different stimulation...
PMC10357146
Lead placements
The finding that more anterior electrode placements were favorable seemed contradictory to that of Goetz and colleagues [
PMC10357146
Single-neuron activity
Assessment of neuronal activity along surgical trajectories suggested that it may be more favorable to target a slower (22.5±6.37 Hz), less regular neuronal population. This observation is in line with a recent report on two cases where similar discharge rates have been detected (19.1±15.1 Hz) [
PMC10357146
Structural and functional connectomic profiles
multiple basal ganglia and limbic areas
CORTEX
The PPN has connections with the cerebral cortex, multiple basal ganglia and limbic areas, the thalamus, other brainstem regions, the spinal cord, and the cerebellum. These connections implicate the PPN in a variety of functions including movement, cognition, and sleep. With respect to cortical connectivity, dense proj...
PMC10357146
Limitations
PD
The medication-OFF Axial-Score and Gait-Score improvements of 7.7% and 16.3%, respectively, were modest; thus, the results should be interpreted with caution. However, a recent study demonstrated that axial symptom score worsening (the only predictor of mortality in patients with PD) was 27% over the course of 10 years...
PMC10357146
Conclusions
Bilateral PPNa-DBS modestly influenced axial symptoms, particularly with respect to gait, in the medication-OFF condition. Electrode placements near the 50% mark of the PMJ line, where slow irregular neurons were encountered along surgical trajectories, yielded better therapeutic responses.
PMC10357146
Supplementary Material
PMC10357146
Supplementary Material
Click here for additional data file.
PMC10357146
ACKNOWLEDGMENTS
The authors thank the patients for participating in this study and Dr. Ramin Azodi-Avval for his contribution to an earlier version of
PMC10357146
SUPPLEMENTARY MATERIAL
The supplementary material is available in the electronic version of this article:
PMC10357146
CONFLICT OF INTEREST
D.W.
FOX
S.B. has ownership interest in Neurostar GmbH (not related to this work). A.G. was supported by research grants (not related to this work) from Medtronic, Boston Scientific, Abbott, the Baden-Wuerttemberg Foundation, and the German Federal Ministry of Education and Research. D.W. has received research support from the ...
PMC10357146
DATA AVAILABILITY
The data will be available upon request, as the ethics approval does not allow uploading the datasets to a publicly available repository.
PMC10357146
REFERENCES
PMC10357146
Background:
Alzheimer’s disease, AD, cognitive impairment
DISEASE PROGRESSION, DISEASE
Alzheimer’s disease (AD) is a chronic condition marked by progressive objective cognitive impairment (OCI). No monotherapy has substantially altered disease progression, suggesting the disease is multifactorial and may require a multimodal therapeutic approach.
PMC10473097
Objective:
infection, cognitive decline
INFECTION
We sought to determine if cognitive function in a sample with OCI would change in response to a multimodal, individualized care plan based on potential contributors to cognitive decline (e.g., nutritional status, infection, etc.).
PMC10473097
Methods:
Participants (
PMC10473097
Results:
At 6 months, mean MoCA scores improved from 19.6±3.1 to 21.7±6.2 (
PMC10473097
Conclusion:
Multiple measures of cognitive function improved after six months of intervention. Our results support the feasibility and impact of a multimodal, individualized treatment approach to OCI, warranting further research.
PMC10473097
INTRODUCTION
cognitive impairment, MCI, Alzheimer’s disease, debilitating disorder, cognitive decline, AD
Alzheimer’s disease (AD) is a debilitating disorder that affects approximately 6 million people in the United States and 50 million people worldwide [Mild cognitive impairment (MCI), a formal diagnosis that includes measures of both objective cognitive impairment (OCI) and subjective cognitive decline, is a known predi...
PMC10473097
METHODS
PMC10473097
Design
infection, cognitive decline, traumatic brain injury
INFECTION, RECRUITMENT, SLEEP APNEA
A protocol-driven, uncontrolled, pragmatic trial was used in order to test feasibility and estimate effects in a real-world clinical setting. This research was approved by the Institutional Review Board (IRB) at the National University of Natural Medicine and was registered on ClinicalTrials.gov as NCT04284449. Partici...
PMC10473097
Participants and inclusion/exclusion criteria
deafness, cognitive impairment, neurological impairment, MCI, visual impairment, somatic disease, dementia, word of mouth, cognitive decline, substance abuse, congenital cognitive impairment or disability
RECRUITMENT
Recruitment was conducted regionally via flyers, social media, email, physician referral, and word of mouth. Inclusion criteria included the following: age≥45 years; cognitive impairment, as demonstrated by a Montreal Cognitive Assessment (MoCA) of 12–23; ability to independently make decisions or have a legal Health C...
PMC10473097
Clinical visit content
A 90-min clinical initial intake visit was conducted for each participant, with subsequent visits lasting from 45–75 min. Clinical visits were usually conducted on the same day as study visits, though participants had the flexibility to schedule clinical visits on days separate from study visits. The baseline clinical ...
PMC10473097
Laboratory evaluation
blood sugar dysregulation
CHRONIC INFECTION, INFLAMMATION, CARDIOVASCULAR DISEASE
To support diagnosis and the development of an individual treatment plan, extensive analysis of blood, urine, hair, and stool samples were performed through commercial clinical laboratory services. These included biomarkers of environmental toxicant exposure, blood sugar dysregulation, gastrointestinal health, nutrient...
PMC10473097
Intervention
PMC10473097
Individualized treatment
cognitive decline
The intervention consisted of a multimodal, individualized medicine treatment plan (i.e., an approach characteristic of the integrative medical care model), as would happen in a real-world setting. Participants were treated for six months with a treatment plan based on individualized evaluations for the presence or abs...
PMC10473097
Lifestyle treatments
Participants were encouraged to increase exercise and adopt novel exercise routines with the goal of getting regular aerobic and strength training exercise. Exercise recommendations were given after assessment of risk, accessibility, and possible maximal impact to the participant. Depending on participant activity leve...
PMC10473097
Dietary treatments
To optimize metabolism, a ketogenic diet was encouraged for all participants [All participants received a commercially available nootropic blend including herbs and nutrients, omega-3 s, and vitamin D (see
PMC10473097
Environmental exposures treatments
low mercury seafood
Strategies to mitigate environmental exposures included: avoidance (e.g., low mercury seafood, mold avoidance or remediation, changes in cleaning or personal care products), support for hepatic detoxification (e.g., herbs, supplemental nutrients, glutathione), binding agents (e.g., cholestyramine, chlorella, charcoal, ...
PMC10473097
Gastrointestinal health treatments
When indicated, improvement in digestion and assimilation of macro- and micronutrients was encouraged through the use of digestive enzymes, probiotics, herb-based and supplemental anti-inflammatories (curcumin, pro-resolvins), gut healing nutrients (e.g., aloe, deglycyrrhizinated licorice, glutamine), gut immune suppor...
PMC10473097
Systemic inflammation treatments
inflammation, infections
INFLAMMATION, INFECTIONS
Systemic inflammation was treated by reducing causes of inflammation, including toxin reduction, treatment of infections, dietary changes, exercise, omega-3 s, and additional dietary supplementation (e.g., curcumin, glutathione, B-vitamins, vitamin C, alpha-lipoic acid).
PMC10473097
Sleep treatments
SLEEP APNEA
Sleep hygiene was supported and tracked using a Garmin Vivo Smart 4 to measure hours and quality of sleep per night, plus oxygen saturation. All participants with O2 saturation levels falling below 85% during sleep were referred to sleep medicine for further evaluation and treatment of potential sleep apnea. Supplement...
PMC10473097
Traumatic brain injury (TBI) treatments
stroke, traumatic brain injuries
STROKE
Those with a history of traumatic brain injuries or stroke were provided oral supplemental phosphatidylcholine, phosphatidylserine, omega-3’s, methyl-B12, and intravenous nicotinamide adenine dinucleotide (i.e., NAD+).
PMC10473097
Hormone treatments
Bio-identical hormone replacement and/or herbal hormonal support was initiated for participants with laboratory confirmed reduction in hormone levels [
PMC10473097
Chronic infection treatments
P., cognitive decline, Herpetic, tick-borne infections
CHRONIC INFECTIONS, POSITIVE
Participants with recurrent or chronic infections associated with cognitive decline were treated. Herpetic outbreaks were prevented with lysine supplementation and Valacyclovir or Acyclovir, to be used at the first sign of prodrome. Positive tick-borne infections were treated with herbal antimicrobials (e.g., berberine...
PMC10473097
Outcome measures
The primary outcome of the study was changes in cognitive scores. Feasibility was qualitatively assessed. Study visits at baseline, month one, month 3, month 6, and month 12 included the following assessments, conducted by clinical research staff:
PMC10473097
Cognitive function testing (primary outcome)
cognitive domains—
BRAIN
The Cambridge Brain Sciences (CBS) assessments were used as the primary measure of cognition throughout the study. The CBS cognitive battery is a validated suite of 12 individual assessments designed to measure function in four cognitive domains— Memory, Reasoning, Verbal Ability, and Concentration. Each domain is asse...
PMC10473097
Montreal Cognitive Assessment (MoCA)
The MoCA is a brief, single page, valid and reliable 30-point screening test widely used clinically to assess and screen cognitive status [
PMC10473097
Adverse events
ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EVENT, ADVERSE EVENT
Adverse events were collected via a standardized adverse events questionnaire at each study and clinical visit, and participants were encouraged to contact study staff between study visits if adverse events occurred. These were tracked in an Adverse Events Log, and any unanticipated and/or severe adverse events were re...
PMC10473097
Statistical analysis
In this uncontrolled study, before and after differences between baseline and endpoint values were calculated. The six-month endpoint was the primary endpoint of the study. An alpha threshold of Standardized individual scores from each CBS test (12 individual tests total) were transformed into four domain scores (Conce...
PMC10473097
DISCUSSION
Alzheimer’s disease, cognitive decline, dementia, cognitive impairment
As a proof-of-concept trial aimed at implementing a complex, multimodal, individualized medicine care plan in a sample of people with cognitive decline, the intervention demonstrated success in feasibility, thus supporting a larger, controlled, multi-site clinical trial. Additionally, results reported here corroborate ...
PMC10473097
Supplementary Material
PMC10473097
Supplementary Table 1
Click here for additional data file.
PMC10473097
Supplementary Table 2
Click here for additional data file.
PMC10473097
Supplementary Table 3
Click here for additional data file.
PMC10473097
Supplementary Table 4
Click here for additional data file.
PMC10473097
ACKNOWLEDGMENTS
We are grateful to Nova Biomedical Corp, Quicksilver Scientific, Diagnostic Solutions Laboratory, DHA Labs, Xymogen, ReadiSorb, Pure Encapsulations, Douglas Labs, and Neurohacker Collective and Integrative Therapeutics for discounts and donations of labs and supplements.
PMC10473097
SUPPLEMENTARY MATERIAL
The supplementary material is available in the electronic version of this article:
PMC10473097
FUNDING
Funding was provided by an anonymous philanthropic donor.Mentorship on this research was supported by grant # K24AT011568 from the National Center for Complementary and Integrative Health of the National Institutes of Health.
PMC10473097
CONFLICT OF INTEREST
This manuscript is not under consideration by another journal, nor has it been published. Dr. Heather Sandison is the owner of a medical clinic and senior living facility. All the other authors have no conflict of interest to report.
PMC10473097
DATA AVAILABILITY
All data generated by our experiments will be shared in the form of publications, abstracts, and presentations. In the case of complex datasets, they will be available as supplementary data in publications or upon request by academic researchers. Where possible, primary data will be securely held for a period of ten ye...
PMC10473097
REFERENCES
PMC10473097
Background:
CM, pain
MECHANICAL LOW BACK PAIN
The study aimed to compare the effects of connective tissue massage (CTM) and classical massage (CM) in patients with chronic mechanical low back pain on pain and autonomic responses and to determine the most effective manual therapy method.
PMC10101266
Methods:
Oswestry disability, CM, pain
MECHANICAL LOW BACK PAIN, HEART
Seventy individuals with chronic mechanical low back pain were randomly divided into CTM (n = 35) and CM (n = 35) groups. The participants were given a 4-week treatment protocol consisting of a hot pack, exercise, and CTM or CM for 20 sessions. A visual analog scale was used to measure pain intensity. Heart rate, blood...
PMC10101266
Results:
Pain
Pain intensity was decreased in both groups (
PMC10101266
Conclusion:
CM, pain
The results of this study showed that massages were similar effect. The fact that CM is a frequently used technique in pain management and is as effective as CTM in autonomic responses will make it more preferred in the clinic.
PMC10101266
1. Introduction
tumor, low back pain, headaches, fracture, muscle soreness, pain, infection, chronic neck pain, CM, drug abuse, Disability, disability
TUMOR, AUTONOMIC NERVOUS SYSTEM IMBALANCE, CHRONIC LOW BACK PAIN, FIBROMYALGIA, MECHANICAL LOW BACK PAIN, INFECTION, ADVERSE EFFECTS, INCREASED SLEEP, MECHANICAL LOW BACK PAIN, OSTEOPOROSIS
Mechanical low back pain is defined as a condition that causes tension, pain, or stiffness in the lumbar region without any specific cause (e.g., infection, tumor, osteoporosis, fracture, etc).Chronic low back pain negatively affects daily life and causes other problems in addition to pain. Disability due to pain can s...
PMC10101266
2. Methods
PMC10101266
2.1. Study design
This study was designed as a randomized, comparative, and mono-center study. The study was conducted in the Orthopedic Rehabilitation Unit of the Health Sciences Faculty of Eastern Mediterranean University between March 2019 and August 2021. The study was approved by the Health Ethics Committee (ETK00-2019-0177) and re...
PMC10101266
2.2. Participants
MECHANICAL LOW BACK PAIN
Patients diagnosed with chronic mechanical low back pain by orthopedics and traumatology doctors in local state hospital were included in the study. The G*Power software program (version 3.0; Kiel, Germany) was used to determine the required sample size for the study. Thus, a sample consisting of 54 participants (27 pe...
PMC10101266
1.2.2. Inclusion and exclusion criteria
congenital malalignment, lower extremity inequality, numbness, pain, malignity
MECHANICAL LOW BACK PAIN, AXIAL SPONDYLOARTHROPATHY
The inclusion criteria were as follows: aged between 20 and 60 years, referred to a physiotherapy clinic, the presence of mechanical low back pain for more than 12 weeks, the absence of neurological problems originating from the lumbar region, and not participating in any physiotherapy and rehabilitation program in the...
PMC10101266
2.3. Randomization
CM
The patients were randomly assigned to one of the following 2 groups: CTM group (n = 35) and CM group (n = 35). Using the minimization method, the groups were made similar in terms of gender, age, and occupation. The participant flow chart is displayed in Figure The participant flow chart according to CONSORT is displa...
PMC10101266
2.4. Interventions
CM
Patients were treated with CM or CTM after a hot pack application (20 minutes) to the lumbar region. In addition, all the participants were given lumbar strengthening and stretching exercises (Table Exercise program.
PMC10101266
1.2.4. Connective tissue massage
hyperemia, strokes
HYPEREMIA, STROKES
The participant was seated on a stool with the entire back and sacral region open, hip and knee flexed at 90°, and feet on the ground during the treatment. While sitting, it was ensured that the back of the individual was straight and their hands supported the thighs for slight loosening of the connective tissue. CTM w...
PMC10101266
2.2.4. Classical massage
CM
CM was applied to the lower and upper back regions in the prone position. Massage oil was used as an intermediate. After general stroking to the entire back, stroking and kneading were applied to the erector spine, latissimus dorsi, and gluteus maximus muscles in the lower back. An upper back massage was performed afte...
PMC10101266
2.5. Outcome measures
pain
All the outcomes were measured by the same physiotherapist the day before the first treatment session, the day after the completion of all treatments, and at the end of the 6-week follow-up. In addition, pain intensity was measured at the end of the 5
PMC10101266
1.2.5. Primary outcome measure
PMC10101266
1.2.5.1. Pain intensity
pain
A visual analog scale (VAS) was used to measure pain intensity.
PMC10101266
2.2.5. Secondary outcome measures
PMC10101266
2.1.2.5. Autonomic functions
CM
BLOOD
Blood pressure, heart rate, and peripheral and local skin temperature changes were measured to evaluate the possible effects of CM and CTM on the autonomic responses.The blood pressure measurements were taken using a Erka Switch model manual sphygmomanometer. For the measurement, the participants were seated in a chair...
PMC10101266
2.6. Disability
Oswestry disability, disability
The Oswestry disability index (ODI) was used to evaluate the disability of the individuals.
PMC10101266
2.7. Health-related quality of life
The short form 36 (SF-36) was used to assess health-related quality of life.
PMC10101266
2.8. Sleep quality
The Pittsburgh sleep quality index (PSQI) was used to determine sleep quality. PSQI is the preferred index in clinical and research studies.
PMC10101266
2.9. Statistical analysis
The obtained data were evaluated with the SPSS Version 22.0 program (SPSS Inc., Chicago, IL). The level of significance was accepted as
PMC10101266
3. Results
CM
The demographic information’s of the groups were similar (Table Comparisons of demographic information of individuals.BMI = body mass index, CM = classical massage, CTM = connective tissue massage. Mann–Whitney Chi-square test.
PMC10101266
3.1. Pain intensity
CM, pain
When the time-dependent changes in the intensity of pain were analyzed, it was found that both treatments provided significant improvements (Table Comparison of pain intensity of the groups.Bold indicates significant values.CM = classical massage, CTM = connective tissue massage, VAS = visual analog scale. Mann–Whitney...
PMC10101266
3.2. Autonomic functions
CM
When the time-dependent changes in the autonomic functions were analyzed, it was found that both treatments provided significant increases in right peripheral temperatures. Besides, it was found that there was a significant increase in left peripheral temperature in the CTM group (Table Comparisons of autonomic functio...
PMC10101266
3.3. Disability
disability, CM
When the time-dependent changes in the disability were analyzed, it was found that both treatments provided significant improvements (Table Comparisons of disability, sleep quality, and health-related quality of life.Bold indicates significant values.CM = classical massage, CTM = connective tissue massage, NT = not tes...
PMC10101266
3.4. Sleep quality
daytime sleep dysfunction, sleep disturbance, CM
When the time-dependent changes in the PSQI were analyzed, it was found that all subcategories (without the sleep medication) provided significant improvements in the CTM group (Table In the CM group, it was found that the sleep duration, sleep disturbance, and daytime sleep dysfunction subcategories provided significa...
PMC10101266
3.5. Health-related quality of life
CM
When the time-dependent changes in the SF-36 results were analyzed, it was found that all categories provided significant improvements in the CTM group (Table There were statistically significant improvements in the CTM group for posttreatment and at the end of the 6-week follow-up physical functioning (posttreatment T...
PMC10101266