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Neurostimulation Device
Brain Stimulation for Stroke Recovery
N/A
Recruiting
Led By Vivek Prabhakaran, MD, PhD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.
Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Study Summary
This trial will test if two non-invasive brain stimulation techniques can help with stroke recovery.
Who is the study for?
This trial is for stroke survivors with moderate arm impairment, who were independent before their stroke. It's not for those allergic to electrode gel or metals, pregnant women, people with MRI contraindications, infectious diseases, or oral lesions.Check my eligibility
What is being tested?
The study tests if brain stimulation via the arm and tongue can help in stroke recovery. It involves behavioral assessments, electric muscle stimulation (FES), MRI scans, EEGs and a system called RecoveriX.See study design
What are the potential side effects?
Potential side effects may include discomfort from the electrical stimulation or wearing of electrodes and possible skin irritation from electrode gels or tapes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was independent in daily activities before my stroke.
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My right hand has moderate impairment due to a stroke.
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I had no arm or hand injuries or conditions before my stroke.
Select...
I have lasting arm weakness from a stroke.
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I had a stroke but do not have arm or hand problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Action Research Arm Test Scores
Secondary outcome measures
Change in Electroencephalogram (EEG) Response Strength
Signal change in functional MRI
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Group - RecoveriXExperimental Treatment1 Intervention
Recruited from participants who have completed the study intervention
Group II: Experimental Group - Immediate BCI TherapyExperimental Treatment4 Interventions
EEG - BCI training (closed loop)
Group III: Experimental Group - Delayed BCI TherapyExperimental Treatment5 Interventions
Scanned and tested 4 times over a 10-week period before EEG-BCI training
Group IV: Control Group 1Active Control4 Interventions
48 stroke patients, 48 participants with risk factors for stroke, 48 healthy controls receiving 4-6 training sessions on the EEG-BCI, pre- and post- behavioral testing, and MRI
Group V: Control Group 2Active Control1 Intervention
24 Stroke Patients with UE impairment receiving standard FES only therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BCI-FES
2013
N/A
~20
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,099 Total Patients Enrolled
13 Trials studying Stroke
270,832 Patients Enrolled for Stroke
American Heart AssociationOTHER
324 Previous Clinical Trials
4,933,490 Total Patients Enrolled
39 Trials studying Stroke
3,924,785 Patients Enrolled for Stroke
Vivek Prabhakaran, MD, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Stroke
144 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to the gel used for electrodes, surgical tape, or metals.I was independent in daily activities before my stroke.You have factors that make you more likely to have a stroke.My right hand has moderate impairment due to a stroke.I had no arm or hand injuries or conditions before my stroke.I cannot have an MRI but can join other parts of the study.People who do not have any medical conditions.I am not currently being treated for any infectious diseases and do not have any visible mouth sores or inflammation.I have lasting arm weakness from a stroke.I had a stroke but do not have arm or hand problems.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental Group - Immediate BCI Therapy
- Group 2: Experimental Group - RecoveriX
- Group 3: Experimental Group - Delayed BCI Therapy
- Group 4: Control Group 1
- Group 5: Control Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many subjects are actively engaged in this research effort?
"Affirmative, clinicaltrials.gov confirms that this trial is currently enrolling patients. It was first advertised on June 1st 2010 and updated most recently on August 3rd 2022. This medical experiment requires 288 subjects from a single site to participate."
Answered by AI
Is the recruitment stage of this clinical trial still open?
"This medical trial is seeking participants, as indicated by the most recent edition on clinicaltrials.gov dated August 3rd 2022. The research was initially posted June 1st 2010."
Answered by AI
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