Behavioral and Neural Correlates of Post-Stroke Fatigue

Part of paid clinical trials in Dallas, Texas.

Sponsor
Texas Woman's University
Study ID
NCT06088914
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Oct 2024
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Fatigue Severity Scale score [ Time Frame: 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Woman's UniversityDallasTexas75235
Hui-Ting Goh
[email protected]
214-689-7723

Find similar trials in Dallas, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Texas Woman's University· Dallas, TX

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