RecruitingNot ApplicableNCT06088914

Behavioral and Neural Correlates of Post-Stroke Fatigue

Sponsor

Texas Woman's University

Enrollment

32 participants

Start Date

Dec 15, 2023

Study Type

INTERVENTIONAL

Conditions

Fatigue Stroke

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

Min Age: 18 Years

Inclusion Criteria5

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.

Exclusion Criteria5

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.

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Interventions

DEVICEAnodal transcranial direct current stimulation

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.

DEVICESham transcranial direct current stimulation

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.