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Change in ambulatory systolic blood pressure (A and B) and diastolic blood pressure (C and D) from baseline to week 8 in patient subgroups based on nocturnal blood pressure dipping status (dipper: A and C, nondipper: B and D). | diabetes | DIABETES | Data are least‐squares mean change±standard error (repeated‐measures ANCOVA model). Daytime: 6 Sacubitril/valsartan was significantly more effective than olmesartan at lowering 24‐hour ambulatory SBP in all patient subgroups, except for those with diabetes (Figure All treatments reduced SBP and DBP throughout the 24‐ho... | PMC10227270 |
Time course of changes in 24‐hour systolic ambulatory blood pressure overall (A) and in patients with a dipper (B) or nondipper (C) profile of nocturnal blood pressure. | ABP indicates ambulatory blood pressure; DBP, diastolic blood pressure; and SBP, systolic blood pressure. * | PMC10227270 | ||
Response to Therapy | On average, >30% of all patients treated with sacubitril/valsartan were defined as responders at week 8 (ie, achieving BP control with 24‐hour SBP <130 mm Hg and 24‐hour DBP <80 mm Hg). In addition, BP control rates at week 8 were higher in both sacubitril/valsartan groups than with olmesartan in the nondipper subgroup... | PMC10227270 | ||
Blood pressure control rate at week 8 in patients with a dipper (A) or nondipper (B) profile of nocturnal blood pressure. | SBP control: 24‐hour SBP <130 mm Hg. DBP control: 24‐hour DBP <80 mm Hg. DBP indicates diastolic blood pressure; and SBP, systolic blood pressure. * | PMC10227270 | ||
Natriuretic Peptides | NT‐proBNP levels were decreased to a greater extent in the sacubitril/valsartan groups compared with olmesartan, and the difference between sacubitril/valsartan 200 mg/d and olmesartan was statistically significant (Figure | PMC10227270 | ||
Overall change from baseline to week 8 in plasma NT‐proBNP levels (ANCOVA model; covariate: baseline NT‐proBNP). NT‐proBNP indicates N‐terminal pro‐B‐type natriuretic peptide. | PMC10227270 | |||
Safety and Tolerability | ADVERSE EVENTS | All treatments were well tolerated, with no significant between‐group differences in reported adverse events (Tables | PMC10227270 | |
DISCUSSION | DBP reductions, hypertension, Hg reduction | HYPERTENSION | This analysis confirms the 24‐hour BP‐lowering effects of the angiotensin receptor neprilysin inhibitor sacubitril/valsartan in Japanese patients with mild‐to‐moderate hypertension and shows that these effects are greater than those of a midrange dose of the angiotensin receptor blocker olmesartan. Furthermore, we have... | PMC10227270 |
CONCLUSIONS | ASSOCIATED CONDITIONS, HYPERTENSION | Sacubitril/valsartan has recently been approved in Japan and China for the treatment of hypertension. This analysis provides the first data on the differential effects of treatment with sacubitril/valsartan on ambulatory BP in patient subgroups based on the nocturnal BP dipping status. It also confirms the potent 24‐ho... | PMC10227270 | |
Sources of Funding | This study was funded by Novartis. | PMC10227270 | ||
Disclosures | Dr Kario has received speaker's honoraria and consulting fees from Novartis Pharmaceuticals and Daiichi Sankyo, and a research grant from Daiichi Sankyo. In addition, Dr Rakugi served as the external medical expert for this study and has received consulting fees from Novartis Pharmaceuticals. D. Yarimizu, Dr Morita, S.... | PMC10227270 | ||
Supporting information | Data S1Tables S1–S3Figures S1–S5Click here for additional data file. | PMC10227270 | ||
Acknowledgments | Medical writing support for an initial draft of this article was provided by Nicola Ryan, an independent medical writer, funded by Novartis. | PMC10227270 | ||
References | PMC10227270 | |||
Background | Cognitive difficulties, infection | INFECTION | Cognitive difficulties are a frequent complaint in long COVID and persist for more than a year post- infection. There is a lack of evidence-based data on effective intervention strategies. Non-pharmacological intervention programs that are used with other neurological populations have not yet been the subject of contro... | PMC10436391 |
Methods/design | fatigue | Patients with long covid are selected and recruited at least three months post-infection. Patients are randomised in a 1:1 ratio into the cognitive (neuropsychological psychoeducation) and affective (emotion management with cognitive-behavioural counselling) intervention arms. The inclusion of 130 patients is planned. ... | PMC10436391 | |
Discussion | cognitive impairment | Given the long-term effects of Covid on cognition and the negative effects of cognitive impairment on quality of life and social participation, it is important to determine whether low-dose, non-pharmacological interventions can be effective. The trial will determine which of the usual types of intervention is the most... | PMC10436391 | |
Trial registration | Clinicaltrials.gov Number: NCT05167266 (21/12/ 2021). | PMC10436391 | ||
Keywords | PMC10436391 | |||
Introduction | PMC10436391 | |||
Background and rationale | multisystemic syndrome, cognitive difficulties, cognitive deficits | DISEASE CAUSED BY SARS-COV-2, INFECTION | It is now acknowledged that the disease caused by SARS-CoV-2 infection, COVID-19, is a multisystemic syndrome [These difficulties appear to have a multifactorial origin. An association is observed between these cognitive deficits and alterations in olfaction and taste [Regarding the prevalence of persistent cognitive d... | PMC10436391 |
Objectives | cognitive difficulties, affective difficulties, cognitive complaints | In this context, our clinical trial aims to explore the potential effectiveness on cognitive complaints of two common low-dose interventions, one targeting cognitive difficulties (cognitive intervention) and the other targeting affective difficulties that may enhance cognitive difficulties, with a CBC approach (affecti... | PMC10436391 | |
Trial design | COVCOG is a multicenter, randomized controlled proof-of-concept trial conducted with two parallel groups (ratio 1:1) comparing psychoeducation interventions that focus on cognitive ( | PMC10436391 | ||
Methods | Reporting and methodology for the proposed study follow the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT). The protocol has been registered on Clinicaltrials.gov: NCT05167266 (21/12/ 2021). | PMC10436391 | ||
Study setting | The trial is conducted by the University of Liege in Belgium. The data are collected in Belgium at four centers: the university of Liège (the Psychological Clinic of University of Liege, CPLU and the university hospital, CHU-Liège), the university hospital of the University of Brussel (ERASME hospital), the regional ho... | PMC10436391 | ||
Eligibility criteria | tumor, cognitive impairment, epilepsy, toxicity, stroke, psychiatric illness, intellectual disability, liver or renal failure, substance abuse, cardiac arrest, neurocognitive disorder, encephalopathy, infection, psychiatric, sepsis, cognitive complaints, hearing or vision disorders, head trauma | TUMOR, EPILEPSY, DRUG WITHDRAWAL, NEUROLOGICAL DISORDER, STROKE, MINOR, CARDIAC ARREST, DISORDERS, ENCEPHALOPATHY, INFECTION, SEPSIS | All volunteers will be screened by a psychologist. To be included in the study, participants must meet the following criteria: be able to understand the information and consent forms; aged 18 to 70 years; medically stable and at least 3 months after a positive COVID 19 infection confirmed either by PCR, self-test or me... | PMC10436391 |
Informed consent | Researchers who take consent from participants are psychologists who are certified in good clinical practice and trained by the principal investigator. The research project is conducted with approval by the relevant Ethic Committees, with the Hospital-Faculty Ethics Committee of CHU Liège serving as the Central Ethic C... | PMC10436391 | ||
Interventions | PMC10436391 | |||
Explanation for the choice of comparator | affective difficulties | Given that it would have been unethical not to propose an intervention, a pragmatic clinical trial logic was adopted by comparing the effect of cognitive psychoeducation program with another psychoeducation program targeting affective difficulties, two common approaches in current practice. We based our reasoning for c... | PMC10436391 | |
Interventions description | cognitive and affective | The cognitive and affective interventions are a 4-session, psycho-educative interventions designed to prevent post-acute cognitive symptoms. Each individual session will last 90 min. One month after the last session, a reactivation session of 30 min is organized (remotely or in person) to reactivate or help the patient... | PMC10436391 | |
Cognitive intervention | The structure of the four sessions is similar: 1) explanation of cognitive (dys)functioning; 2) identification of significant problems in the daily life of each participant; 3) explanation and application of (meta)cognitive strategies. Throughout the presentation, the risks of causal over-attribution (i.e., misattribut... | PMC10436391 | ||
Module 1—Cognition in COVID; sleep and fatigue | fatigue, cognitive deficits | The first step is to provide feedback on the results of cognitive assessment from the baseline visit and to relate it to the cognitive deficits observed in the long covid. Validating and normalizing symptomatology while simultaneously highlighting appropriate strategies to alleviate problems is an important step in psy... | PMC10436391 | |
Module 2—Working memory and attentional functions | Psychoeducation focuses on 1) how to optimize the environment to minimize difficulties (how to reduce interference and dual-task situations, etc.); 2) how to optimize task design to minimize difficulties. If necessary, Time Pressure Management (TPM) is also used to improve adaptation to slowed information processing [ | PMC10436391 | ||
Module 3 – Executive control | cognitive impairment | Regarding executive functions, the literature on mild cognitive impairment supports the use of instructional procedures for training patients to regulate their behavior and thinking (see DCoE and DVBIC consensus conference) [ | PMC10436391 | |
Module 4 – Long-term memory | memory impairments | AIDS | Practice-standards for mild memory impairments suggest the use of internalized strategies (e.g., mental imagery) and external memory compensations (e.g., notebook, diary) to enhance retrieval of information. Training the use of these types of memory compensations and aids within activities of daily living continues to ... | PMC10436391 |
Affective intervention | The structure of the four sessions will be similar: 1) analysis of a fictitious vignette illustrating the thoughts and affect that can be provoked by the long COVID; 2) in connection with the explanations, identification of significant problems in the daily life of each participant; 3) explanation of psychological func... | PMC10436391 | ||
Module 1—Recognizing emotions and affective states | SECONDARY | Psychoeducation on emotions will be proposed (e.g., triggers of emotions, category of primary and secondary emotions, meaning of emotions). The patient will be asked to reflect on his or her emotions associated with long-covid and their manifestations (internal and external physical and physiological manifestations; co... | PMC10436391 | |
Module 2—Accepting and communicating about difficulties | cognitive difficulties | After a review of the patient's diary, the patient will be asked to share his or her observations on the emotion self-observation. Afterwards, the interest of being able to communicate calmly about one's cognitive difficulties and one's feelings in relation to the COVID will be discussed with the patient. The principle... | PMC10436391 | |
Module 3—Accepting the uncertainty associated with difficulties | Following Ladouceur's model of uncertainty management [ | PMC10436391 | ||
Module 4—Behavioral activation | fatigue | EVENTS | Patients will be invited to identify their values to better calibrate the choice of activities according to their fatigue but also according to what is important to them. If the patient has difficulties with ruminations, the impact of these on activation will be discussed. A behavioral activation plan will also be cons... | PMC10436391 |
Criteria for discontinuing or modifying allocated interventions | Reasons for discontinuing protocol treatment may include, but are not limited to, the patient's desire not to continue or a change in health status requiring alternative treatment. There are no reasons envisaged for a change of allocation. | PMC10436391 | ||
Strategies to improve adherence to interventions | Clinicians are trained in psychoeducation interventions; manuals list each module ingredient in detail (with examples of instructions and exercises to be provided to patients). A roadmap summarizes the sequence of steps in each module. An adherence checklist with the essential topics to be covered is to be completed by... | PMC10436391 | ||
Relevant concomitant care permitted or prohibited during the trial | Treatment similar to that of one of the two arms is not accepted. | PMC10436391 | ||
Provisions for post-trial care | Not applicable. | PMC10436391 | ||
Baseline and endline assessment | A psychological evaluation is administered before and 2 months and 8 months after treatment. This evaluation involves 2 sessions of 90 min. | PMC10436391 | ||
Primary outcome | forgetfulness, memory difficulties | The primary outcome is a subjective report of difficulties experienced by patients in daily life at two months post-intervention measured via two questionnaires.The Behavioral Rating Inventory of Executive Function (BRIEF) is a validated questionnaire assessing the main cognitive complaints of the patients (e.g., atten... | PMC10436391 | |
Secondary outcome | cognitive difficulties, fatigue | SECONDARY | BRIEF and MMQ will also be administered 8 months after intervention. Other secondary outcomes at 2- and 8-months post-intervention are [1] quality of life; [2] the presence of objective cognitive difficulties, assessed by neuropsychological tasks; [3] fatigue level and sleep quality; [4] psychological distress; [5] wor... | PMC10436391 |
Quality of life (QOL) | The status of Quality of life is self-assessed through the Quality of Life Systemic Inventory [Participants also complete the EQ-5D [ | PMC10436391 | ||
Neuropsychological tasks | cognitive difficulties | A cognitive assessment is carried out by a neuropsychologist before the intervention as well as 2 months and 8 months after the intervention. The battery takes about 150 min to complete and is administered in two sessions. It includes several psychometric tests with normative data for french-speaking population.The tas... | PMC10436391 | |
Fatigue and sleep | Fatigue | MULTIPLE SCLEROSIS | A 19-item self-report inventory (Pittsburgh Sleep Quality Inventory, PSQI [Fatigue level was also examined through the Modified Fatigue Impact Scale (M-FIS). The M-FIS is a 21-item self-report questionnaire developed by the US NMSS (National Multiple Sclerosis Society) and derived from the original 40-item Fatigue Scal... | PMC10436391 |
Psychological distress | The Outcome Questionnaire 45 (OQ-45) [ | PMC10436391 | ||
Work and activity | The Work Productivity and Activity Impairment (WPAI) [ | PMC10436391 | ||
Participant timeline | After a telephone screening, the patients corresponding to the eligibility criteria are invited to participate in the study with a first appointment for the baseline. The full assessment protocol is then administered. Individuals completing the inclusion criteria are randomized within one week of baseline and intervent... | PMC10436391 | ||
Sample size | RECRUITMENT | The uniqueness of our research does not make it possible to determine the exact expected effect size. Thus, we decided to follow a proof-of-concept study logic with a pragmatic approach to setting our sample size. A feasibility analysis led us to the conclusion that we could reach a sample of 130 participants in 10 mon... | PMC10436391 | |
Recruitment | word of mouth | An initial set of patients will be identified by the usual physicians/clinical teams of the centers participating in the study. Patients will be informed and will contact the study team. Participants will also be recruited by word of mouth ("flyer", Covid long facebook group, primary care physicians). Finally, if neede... | PMC10436391 | |
Assignment of interventions: allocation | PMC10436391 | |||
Sequence generation | milder difficulties, cognitive impairments, cognitive complaints, cognitive deficits | SECONDARY | Given our small sample size, and because individuals with more severe cognitive impairments might respond differently to the intervention than those with milder difficulties, we will use randomization by minimization. Although severity and interval since COVID episode are probably important prognostic factors in outcom... | PMC10436391 |
Concealment mechanism and Implementation | After the baseline session, an attribution request is then emailed, including the ID, to a researcher responsible for the attribution process with the QMinim software. This researcher does not participate in the follow-up assessment. This researcher then sets up the appointment with the clinician of the assigned arm. | PMC10436391 | ||
Assignment of interventions: Blinding | PMC10436391 | |||
Who will be blinded | cognitive difficulties | BLIND | The statistician will be blind to the content of the intervention arm that will be called “A” and “B”. The neuropsychologists who perform the baseline assessment do not know about the randomisation (which is only carried out after the visits). The neuropsychologists that will be in charge of follow-up will also be blin... | PMC10436391 |
Procedure for unblinding if needed | Not applicable: the patients and the clinicians know the intervention as the content of the sessions is different in the two arms. | PMC10436391 | ||
Data collection and management | PMC10436391 | |||
Plans for assessment and collection of outcomes | All tests and questionnaires are administered by a trained psychologist specialized in neuropsychology. The primary outcome is administered via a computerized questionnaire system in the eCRF (Castor). MMQ and BRIEF (primary outcome) will be remotely administered again after a 2-week interval to take account of fluctua... | PMC10436391 | ||
Plans to promote participant retention and complete follow-up | Patients will be reminded by the researcher to log in and complete assessments. | PMC10436391 | ||
Data management | SECONDARY | The data are entered into the eCRF by the clinician researchers in charge of the evaluation. A manual was written to guide the encoding. Double entries were made on the first patients. 100% of the primary and 10% of the secondary outcomes are verified by independent monitor of Antwerpen University Hospital Clinical Tri... | PMC10436391 | |
Confidentiality | Confidentiality and data protection will comply with European and Belgian directives on the protection of individuals with regard to the processing of personal data and on the free movement of such data (GDPR). Standard operating procedure (SOP) for data protection are detailed on the website of the Faculty of Psycholo... | PMC10436391 | ||
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use | Not applicable for this study. | PMC10436391 | ||
Statistical methods | PMC10436391 | |||
Statistical methods for primary and secondary outcomes | PMC10436391 | |||
Summary of baseline data and flow of patients | Preliminary analyses will be conducted to ensure comparability of both groups on demographic (sex, age, education years) and clinical characteristics at baseline. Two-sided independent sample t tests will be conducted for continuous variables and categorical variables will be analyzed with Fisher exact tests. A consort... | PMC10436391 | ||
Primary outcome analysis | Primary outcome will be first analyzed on an intention-to-treat (ITT) basis, including all patients as originally allocated after randomisation. For missing information due to patient drop-out, we will rely on the linear mixed model and consider the baseline data as part of the outcome matrix. We will also perform a pe... | PMC10436391 | ||
Secondary outcome analysis | SECONDARY | Mixed linear models will also be used to assess the maintenance of effect across time (baseline, immediate and long-term follow-up). We will re-run the same analysis as for primary outcome, this time by including scores at long-term follow-up. Intervention effect size will be estimated using the same mixed models for e... | PMC10436391 | |
Interim analyses | infection | INFECTION | The objective of interim analyses will be to determine if there exist profiles of patients with specific characteristics, to assess if the interventions act differently according to subgroup. We hypothesize a subdivision of patients according to the presence of a more cognitive or psychological profile. For this Latent... | PMC10436391 |
Methods for additional analyses (e.g. subgroup analyses) | cognitive sequelae | Analyses will be conducted to identify trajectories of participants according to their baseline characteristics (i.e., subgroup identified with the cluster analysis) and the allocated intervention. To explore the effects of the intervention on the two primary outcome measures according to the baseline participant chara... | PMC10436391 | |
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data | SECONDARY | In the ITT analysis, we will measure our primary and key secondary outcomes by patient report in the last assessment. For the PP analysis, the proposed linear mixed model allows missing values at certain time points. The missing value assumption of the model is Missing At Random which means that missing values can only... | PMC10436391 | |
Plans to give access to the full protocol, participant level-data and statistical code | The complete protocol is available on the KCE website. ( | PMC10436391 | ||
Oversight and monitoring | PMC10436391 | |||
Composition of the coordinating centre and trial steering committee | In summary, ULiège is the study Sponsor. Willems S. and Collette F. are the Chief Investigator (CI) and responsible for clinical elements of the trial. ULiège and UZA CTC are both responsible for project management. ULiège and UZA CTC will hold joint data controller responsibilities. | PMC10436391 | ||
Trial Steering Committee (TSC) | A TSC meets three times in the first year and twice in the second. The committee will provide overall supervision of the trial and ensure that the study is conducted according to the protocol and within the overarching ethical framework. It is composed of chief investigators, trial project manager, statistician, clinic... | PMC10436391 | ||
Trial Management Group (TMG) | The TMG is the executive decision-making body and is responsible for the day-to-day running and management of the trial. It is led by the CIs and consists of representative of UZA CTC, representative of the funder, project manager and principal investigator from coordinating centre. The team meets each trimester (or mo... | PMC10436391 | ||
Composition of the data monitoring committee, its role and reporting structure | ICH | Charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed.Data monitoring is under the responsibility of CTC UZA, that is independent from the sponsor and funder. A Clinical Monitoring Plan (CMP) was conjointly written by the CTC UZA, in collaboration with the chief investig... | PMC10436391 | |
Adverse event reporting and harms | cognitive difficulties, anxio-depressive | ADVERSE EVENTS, ADVERSE EVENT | The project does involve interventions, but they are considered ‘low risk’ with no anticipated serious adverse events. Here, we should observe only mild adverse events related to the interventions, such as increased anxio-depressive affects in some patients when faced with cognitive difficulties. Such adverse events wi... | PMC10436391 |
Frequency and plans for auditing trial conduct | Trial conduct will be closely monitored by independent subgroup (as previously described). An independent audit will be ordered by the funder. | PMC10436391 | ||
Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) | Any proposed amendments to the protocol will first be discussed within the Trial Management Group and the Trial Steering Committee. Approval will be required from all parties before implementation (Funder and Ethics Committee). The chief investigators will take responsibility for communicating protocol amendments to al... | PMC10436391 | ||
Dissemination plans | cognitive difficulties | Scientific results of the project will be disseminated via publications in peer-reviewed journals and in abstracts of national and international conferences. Open access will be guaranteed by filling all publications related to the project in the ULiège institutional repository—ORBI. Decisions about the scientific cont... | PMC10436391 | |
Discussion | fatigue, traumatic brain injury, cognitive disorders, anxiety, depression, cognitive difficulties, post-traumatic symptoms, cognitive deficits, cognitive impairments, cognitive complaints, neurological complaints, disability | This randomized controlled trial with minimization aims to test the effectiveness of two approaches commonly proposed to people with cognitive complaints on patients with long covid. Because of the impact of cognitive disorders on functional disability and long-term quality of life, such clinical trials seem essential ... | PMC10436391 | |
Acknowledgements | Gilles, Alexia, Charonitis | We would like to thank all the who participated in the construction of the material for the two interventions, as well as in the numerous meetings to prepare the trial : Maud Billet (ULiège, PsyNCog) ; Christina Léonard (ULiège, PsyNCog) ; Guillemin, Camille (ULiège, PsyNCog) ; Mathilde Reyt (ULiège, GIGA) ; Florence R... | PMC10436391 | |
Public and patient involvement | EVENT | A partnership with patients has been set up from the design of the study, to validate the question, draw up the study plan, assess the acceptability of the protocol (assessment and intervention) and check all the study documents (information and consent letter, intervention manuals). Two patients are included in the st... | PMC10436391 | |
Authors’ contributions | SW is chief investigator; she conceived the study and led the development of the proposal and protocol; she contributed to the development of the statistical design; led the construction of the clinical material; she has drafted the work; she contributes to the acquisition of data. FC is chief investigator; she conceiv... | PMC10436391 | ||
Funding | This study is funded by the KCE Trials program of the Belgian Federal Center of Expertise for Health Care (KCE) (KCE ref: LCOV21-1303). The funder itself is not involved in the reporting of the study. It will however take a key monitoring role, to ensure that the study progresses satisfactorily according to expected ti... | PMC10436391 | ||
Availability of data and materials | The dataset generated during the trial will be available upon reasonable request from the CI. The data will be available following publication of the trial results. | PMC10436391 | ||
Declarations | PMC10436391 | |||
Ethics approval and consent to participate | This study complies with the Declaration of Helsinki. The protocol and all materials have been reviewed and approved by the CHULiege Ethical Review Committee (B7072021000098) and all Centres Committees (REF:2021/432). Written informed consent will be obtained from all participants. | PMC10436391 | ||
Consent for publication | Not applicable. | PMC10436391 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10436391 | ||
References | PMC10436391 | |||
Simple Summary | ASD, impaired language and communication skills, Autism spectrum disorder, impaired social–emotional interactions, aggressive behavior, neurodevelopmental disorder, autism | Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause impaired social–emotional interactions, impaired language and communication skills, repetitive or restrictive behaviors, and sometimes aggressive behavior. An emerging topic in research is the imbalance between bodily oxidative systems and a... | PMC10660524 | |
Abstract | neurodevelopmental disorder, ASD, Autism spectrum disorder, autism spectrum disorder | OXIDATIVE STRESS | Autism spectrum disorder (ASD) is a type of neurodevelopmental disorder that has been diagnosed in an increasing number of children around the world. The existing data suggest that early diagnosis and intervention can improve ASD outcomes. The causes of ASD remain complex and unclear, and there are currently no clinica... | PMC10660524 |
1. Introduction | impaired neurotransmission, ASD, metabolic abnormalities, behavioral deficits, traumatic brain injuries, Autism spectrum disorder, fibrogenesis, neurodevelopmental disorder, psychotic disorders, mitochondrial dysfunction, DSM-5 | DISORDER, DISORDERS, PROLIFERATION, NEURODEGENERATIVE DISEASES, DISORDERS, MULTIPLE SCLEROSIS, LACTIC ACIDOSIS, MITOCHONDRIAL DYSFUNCTION, OXIDATIVE STRESS, CORTEX | Autism spectrum disorder (ASD) is a neurodevelopmental disorder defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) as observable behavioral deficits in social communication and social interaction across multiple contexts. Oftentimes, patients with ASD present with difficulties r... | PMC10660524 |
2. Methods and Materials | PMC10660524 |
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