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Brain-Computer Interface

BCI Technology for Stroke Rehabilitation

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

Right hand dominant - affected arm

Mild to moderate unilateral upper extremity impairment or severe unilateral upper extremity impairment

Must not have

Concurrent upper extremity therapy, other neurological or psychiatric disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if electrical brain signals can help improve movement and function after a stroke.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort from EEG cap use, skin irritation from electrodes during FES therapy, temporary fatigue following exercises, and rare risks associated with MRI such as reactions to contrast material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I had no arm or hand injuries or conditions before my stroke.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months for reporting.

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

Stroke Impact Scale

Secondary study objectives

Blood coagulation tests

Change in Electroencephalogram (EEG) Response Strength

Change in Hand Grip Strength

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Active FESExperimental Treatment4 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 FESActive Control3 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.

0 / 4Eligibility criteria met