Behavioral and Neural Correlates of Post-Stroke Fatigue

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Texas Woman's University
RECRUITING
Dallas
Contact Information
Primary
Hui-Ting Goh
HGoh1@twu.edu
4697405662
Time Frame
Start Date: 2023-12-15
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 32
Treatments
Experimental: Anodal tDCS group
Participants will receive anodal tDCS applied to the ipsilesional primary motor cortex.
Sham_comparator: Sham tDCS
Participants will receive sham tDCS applied to the ipsilesional primary motor cortex
Related Therapeutic Areas
Sponsors
Leads: Texas Woman's University
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov