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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)
Must not have
Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months
Awards & highlights
Summary
This trial tests if stimulating arm muscles and sending gentle electrical signals through the tongue can help stroke patients recover better. It targets adults who have trouble moving their arms and hands after a stroke. The treatment uses a brain-computer system to help retrain the brain and muscles to work together.
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.
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.
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.
Select...
My right hand has moderate impairment due to a stroke.
Select...
I had no arm or hand injuries or conditions before my stroke.
Select...
I have lasting arm weakness from a stroke.
Select...
I had a stroke but do not have arm or hand problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently being treated for any infectious diseases and do not have any visible mouth sores or inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Action Research Arm Test Scores
Secondary study objectives
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Muscle stimulation of the arm, or direct muscle activation, works by electrically stimulating the muscles to promote movement and strength, which can help in regaining motor function lost due to stroke. This method aims to enhance muscle re-education and prevent atrophy.
Neuro-stimulation through the tongue, or neural pathway stimulation, involves stimulating the cranial nerves to promote neuroplasticity and improve brain function. This can help in re-establishing neural connections that were damaged during the stroke.
Both treatments are non-invasive and aim to accelerate recovery by leveraging the body's natural ability to heal and adapt, which is crucial for improving the quality of life and functional independence of stroke patients.
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,218 Previous Clinical Trials
3,166,839 Total Patients Enrolled
14 Trials studying Stroke
270,848 Patients Enrolled for Stroke
American Heart AssociationOTHER
344 Previous Clinical Trials
4,971,273 Total Patients Enrolled
41 Trials studying Stroke
3,926,647 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.
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