BCI Technology for Stroke Rehabilitation

Overseen By Suzanne Hanson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Other neurological, psychiatric disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to determine if functional muscle stimulation, directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI). Participants will include stroke patients with upper-limb hemiparesis and can expect to be on study for approximately 4 months.

Who Is on the Research Team?

Vivek Prabhakaran, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for stroke patients with mild to severe weakness in one arm, who can consent for themselves, and were right-handed before the stroke. They should have had their first stroke within the last year and not be receiving other arm therapies or have pre-existing conditions affecting their arms.

Inclusion Criteria

My right hand is my dominant hand and it is affected.

I have arm weakness or difficulty moving my arm on one side.

Must be able to provide informed consent on their own behalf

Exclusion Criteria

I am receiving therapy for my arm or have a neurological or psychiatric condition.

I am able to understand and follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either active or passive FES intervention, including EEG guided muscle stimulation, behavioral assessments, fMRI, and FES treatment

16 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Functional Electric Stimulation (FES)
• Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Trial Overview The study tests if using brain signals (EEG) to control muscle stimulation helps improve arm function after a stroke. It involves behavioral assessments, brain scans (fMRI), and functional electric stimulation over about 4 months.

How Is the Trial Designed?

Group I: Active FES Experimental Treatment 4 Interventions

Subjects randomized to this experimental group will be asked to complete the active FES intervention which include EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, functional electric stimulation (FES) treatment, and EEG.

Group II: Passive FES Active Control 3 Interventions

Subjects randomized to this control group will be asked to participate in a passive FES intervention or non-EEG guided muscle stimulation. Participation will include behavioral assessments, functional magnetic resonance imaging, and functional electric stimulation (FES) treatment.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+