84 Participants Needed

BCI Technology for Stroke Rehabilitation

GG
SH
Overseen BySuzanne Hanson, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Wisconsin, Madison
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

Research Team

VP

Vivek Prabhakaran, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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
See 2 more

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

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

Treatment Details

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.
Participant Groups
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.

Find a Clinic Near You

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+