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Behavioural Intervention

Electrical Stimulation for Post-Stroke Fatigue

N/A

Recruiting

Led By Hui-Ting Goh

Research Sponsored by Texas Woman's University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task

Be at least 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

Study Summary

This trial will look at how 5-daily sessions of electrical stimulation can reduce fatigue after stroke. Fatigue will be measured using clinical, behavioral and neurophysiological outcomes.

Who is the study for?

This trial is for adults who've had a stroke at least 3 months ago, can follow simple instructions, and experience significant fatigue (scoring ≥4 on the Fatigue Severity Scale). They should be able to move their affected arm somewhat. People with acute health issues, contraindications to the study's procedures, severe depression, pain that affects arm movement or medications influencing fatigue levels cannot participate.Check my eligibility

What is being tested?

The study tests if anodal transcranial direct current stimulation (tDCS) over part of the brain affected by stroke can reduce post-stroke fatigue. Participants will get either real or sham tDCS daily for five days. The effects on behavior and brain function are assessed before, right after treatment and one month later.See study design

What are the potential side effects?

Transcranial direct current stimulation may cause mild side effects like itching, tingling or discomfort at the electrode site during application. Serious side effects are rare but could include skin burns or mood changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move my arm enough to reach out for things.

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I am 18 years old or older.

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I can understand and follow three-step instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatigue Severity Scale score

Input-output curve slope

Secondary outcome measures

Borg Rating of Perceived Exertion

Fatigue Scale for Motor and Cognitive Function

Functional connectivity of the fronto-striato-thalamic network

+3 more

Other outcome measures

Functional connectivity of other established brain networks.

Reach error

Reach movement time

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Anodal tDCS groupExperimental Treatment1 Intervention

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

Group II: Sham tDCSPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anodal transcranial direct current stimulation

2016

Completed Phase 3

~180

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,818 Total Patients Enrolled

6 Trials studying Fatigue

345 Patients Enrolled for Fatigue

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,965 Previous Clinical Trials

2,672,765 Total Patients Enrolled

1 Trials studying Fatigue

12 Patients Enrolled for Fatigue

Texas Woman's UniversityLead Sponsor

86 Previous Clinical Trials

5,848 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment accessible for participation at present?

"Data from clinicaltrials.gov reveals that this trial is no longer accepting applicants, as the study was initially posted on November 1st 2023 and most recently modified on October 12th 2023. Fortunately, there are over 1300 other trials currently seeking enrolment at this moment in time."

Answered by AI

What is the purpose of this experiment?

"This clinical trial's primary aim is to measure the input-output curve slope of participants. In addition, secondary objectives consist of assessing functional connectivity within a fronto-striato-thalamic network via 10 minute resting state fMRI scans, using the Fatigue Scale for Motor and Cognitive Function (a 20 item Likert scale questionnaire) and recording Visual Analog Scale-Fatigue scores (10cm single dimension scales). Outcomes will be assessed at baseline, 7 days after intervention commencement, and 5 weeks following baseline measurements."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Behavioral and Neural Correlates of Post-Stroke Fatigue

2023. "Behavioral and Neural Correlates of Post-Stroke Fatigue". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088914.