Behavioral and Neural Correlates of Post-Stroke Fatigue

NCT06088914 | Recruiting FDA Device

• 3 other identifiers: IRB-FY2023-2261R15HD109737-01A1R15HD109737
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are: Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF. Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1. Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF. Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.

Conditions

Stroke; Fatigue

Outcome Measures

Primary Outcomes (2)

• Fatigue Severity Scale score

  This is a 9 item questionnaire and each item is rated on a Likert scale 1-7. Participants will rate their responseS based on their previous week experience. A higher score suggests more fatigue.

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

• Input-output curve slope

  Brain excitability will be indexed using the input-output curve slope acquired with single-pulse transcranial magnetic stimulation (TMS)protocol. A greater slope value indicates a greater brain excitability.

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Secondary Outcomes (6)

• Borg Rating of Perceived Exertion

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

• Functional connectivity of the fronto-striato-thalamic network

  This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

• Fatigue Scale for Motor and Cognitive Function

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

• Visual Analog Scale-Fatigue

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

• Paas Mental Effort Rating Scale

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Other Outcomes (4)

• Functional connectivity of other established brain networks.

  This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

• Reach movement time

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

• Reach reaction time

  This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Study Arms (2)

Anodal tDCS group

EXPERIMENTAL

Participants will receive anodal tDCS applied to the ipsilesional primary motor cortex.

Device: Anodal transcranial direct current stimulation

Sham tDCS

SHAM COMPARATOR

Participants will receive sham tDCS applied to the ipsilesional primary motor cortex

Device: Sham transcranial direct current stimulation

Interventions

Anodal transcranial direct current stimulation DEVICE

Anodal tDCS will be delivered for 5 consecutive days. Participants will receive 2 mA of stimulation for 20 minutes with the anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.

Anodal tDCS group

Sham transcranial direct current stimulation DEVICE

Sham tDCS will be delivered for 5 consecutive days. Participants will receive sham stimulation for 20 minutes with the current intensity ramping down after 30 seconds of stimulation. The anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.

Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• be at least 18 years old;
• have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;
• have an average score ≥ 4 on FSS;
• have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;
• be able to follow three-step commands.

You may not qualify if:

• acute medical problems;
• the presence of any contraindication to tDCS, MRI or TMS;
• the presence of significant depression (score \> 10 on the Patient Health Questionnaire-9);
• significant pain in the upper extremities that interferes with movements; or
• use of medication which may affect the level of fatigue.

Sponsors & Collaborators

• Texas Woman's University: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Texas Woman's University

Dallas, Texas, 75235, United States

RECRUITING

Related Publications (1)

• Liao KC, Christian I, Stewart J, Trudelle-Jackson E, Wang W, Shang T, Goh HT. Behavioral and Neural correlates of Post-STROKE Fatigue: A randomized controlled trial protocol. PLoS One. 2025 Jun 6;20(6):e0324591. doi: 10.1371/journal.pone.0324591. eCollection 2025.

  PMID: 40478794 DERIVED

MeSH Terms

Conditions

Stroke; Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Hui-Ting Goh

  Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Ting Goh

CONTACT

4697405662; HGoh1@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 18, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Upon the publication of the manuscripts (\~12 months after study completion).
• Access Criteria: Qualified researchers can contact PI via email (hgoh1@twu.edu) to request access to the de-identified data. DASH users can request access to the de-identified data deposited to the NICH DASH.

Locations

US (1)