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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
Fatigue severity score average >4 (severe fatigue)
Be older than 18 years old
Must not have
Signs of skin rash, infection, or laceration in the supraorbital region where the tDCS will be applied
History of seizure
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
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 belowSelect...
I experience severe fatigue.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no skin issues like rash or cuts where the device will be placed on my head.
Select...
I have had seizures in the past.
Timeline
Screening ~ 3 weeks3 visits
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))
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))
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 moreTrial 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.
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Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,064 Previous Clinical Trials
1,319,162 Total Patients Enrolled
2 Trials studying Fatigue
95 Patients Enrolled for Fatigue
Joan M Stilling, MD, MSPrincipal InvestigatorWeill Medical College of Cornell University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a low score on a test that suggests you may have a major brain function problem.I have no skin issues like rash or cuts where the device will be placed on my head.I experience severe fatigue.I am over 18 years old.It has been over 3 months since my stroke, confirmed by a brain scan.I have someone who can be with me during my treatment sessions.I have had seizures in the past.You have metal in your head or certain implanted devices in your head or chest.You have had a serious head injury in the past.You have a score of 10 or more on a questionnaire that shows you may have moderate to severe depression or anxiety.You have other significant neurological, medical, or mental health conditions that the site investigator thinks could affect the study results.
Research Study Groups:
This trial has the following groups:- Group 1: Real tDCS stimulation
- Group 2: Sham tDCS stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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