RECRUITING

Behavioral and Neural Correlates of Post-Stroke Fatigue

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Behavioral and Neural Correlates of Post-Stroke Fatigue

Quick Facts

Study Start:2023-12-15
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06088914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. be at least 18 years old;
  2. 2. have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;
  3. 3. have an average score ≥ 4 on FSS;
  4. 4. have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;
  5. 5. be able to follow three-step commands.
  1. 1. acute medical problems;
  2. 2. the presence of any contraindication to tDCS, MRI or TMS;
  3. 3. the presence of significant depression (score \> 10 on the Patient Health Questionnaire-9);
  4. 4. significant pain in the upper extremities that interferes with movements; or
  5. 5. use of medication which may affect the level of fatigue.

Contacts and Locations

Study Contact

Hui-Ting Goh
CONTACT
4697405662
HGoh1@twu.edu

Principal Investigator

Hui-Ting Goh
PRINCIPAL_INVESTIGATOR
Physical Therapy

Study Locations (Sites)

Texas Woman's University
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: Texas Woman's University

  • Hui-Ting Goh, PRINCIPAL_INVESTIGATOR, Physical Therapy

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-15
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-12-15
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Stroke
  • Fatigue