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Behavioural Intervention

tDCS for Post-Stroke Fatigue

Phase 2
Recruiting
Led By Joan M Stilling, MD, MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients aged >18 years
Greater than 3 months from first hemorrhagic or ischemic stroke (subacute to chronic), confirmed through neuroimaging (CT or MRI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52)
Awards & highlights

Study Summary

This trial will explore if mild electric stimulation of the brain can reduce fatigue after a stroke.

Who is the study for?
This trial is for adults over 18 who've had their first stroke more than 3 months ago and are experiencing severe fatigue. They must have a stable medication routine and someone to accompany them during treatment sessions. People with metal in the head, pacemakers, seizure history, severe brain injuries, depression/anxiety or cognitive disorders, skin issues where the device will be placed, or other major health problems can't participate.Check my eligibility
What is being tested?
The study tests if anodal tDCS (a non-invasive brain stimulation technique) applied to the left frontal area of the head can reduce post-stroke fatigue. Participants will receive either real tDCS using Soterix Mini-CT stimulator or a sham (fake) version to compare effects.See study design
What are the potential side effects?
tDCS may cause mild side effects like itching, tingling at the electrode site during application, headache, fatigue after treatment or discomfort. Serious side effects are rare but could include seizures or skin irritation under electrodes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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It has been over 3 months since my stroke, confirmed by a brain scan.
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I have someone who can be with me during my treatment sessions.
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I experience severe fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52))
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening (-1 to -14 days), baseline (day 1), during-treatment (day 7-9), post-treatment (day 14-21), 1 month post-treatment (day 45-52)) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline Fatigue Severity Scale - 7 (FSS-7)
Secondary outcome measures
Change in resting state brain functional connectivity.
Mean Client Satisfaction Questionnaire - 8 (CSQ-8)
Mean change from baseline Frenchay activities index
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Real tDCS stimulationExperimental Treatment1 Intervention
Subjects randomized to receive real/active electrical stimulation.
Group II: Sham tDCS stimulationPlacebo Group1 Intervention
Subjects randomized to receive sham/non-activating electrical stimulation.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,504 Total Patients Enrolled
2 Trials studying Fatigue
95 Patients Enrolled for Fatigue
Joan M Stilling, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

Soterix Mini-CT tDCS stimulator (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05816603 — Phase 2
Fatigue Research Study Groups: Real tDCS stimulation, Sham tDCS stimulation
Fatigue Clinical Trial 2023: Soterix Mini-CT tDCS stimulator Highlights & Side Effects. Trial Name: NCT05816603 — Phase 2
Soterix Mini-CT tDCS stimulator (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05816603 — Phase 2

Frequently Asked Questions

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

Does the FDA recognize Real tDCS stimulation as a legitimate therapeutic tool?

"The safety score of Real tdcs stimulation was determined to be a 2, as there is existing data that demonstrates its security but no proof showing it's efficacy."

Answered by AI

Is this research endeavor currently seeking participants?

"The information stored on clinicaltrials.gov indicates that this trial is not recruiting patients at the moment, since it was last updated April 3rd 2023. Despite this, there are still 1267 other medical studies actively enrolling participants across the world right now."

Answered by AI
~9 spots leftby Dec 2024