Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

Last updated: October 20, 2025
Sponsor: University of Wisconsin, Madison
Overall Status: Completed

Phase

N/A

Condition

Stroke

Aneurysm

Cerebral Ischemia

Treatment

Magnetic Resonance Imaging

Functional Electric Stimulation (FES)

EEG

Clinical Study ID

NCT04141774
2018-0971
SMPH/RADIOLOGY
A539300
1R01NS105646-01A1
Protocol Version 2/1/22
  • Ages 50-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New-onset ischemic stroke 12 months prior - chronic time frame;

  • Right hand dominant - affected arm;

  • Mild to moderate unilateral upper extremity impairment or severe unilateral upperextremity impairment;

  • No upper extremity injury or conditions that limited use prior to the stroke;

  • Must be able to provide informed consent on their own behalf.

Exclusion

Exclusion Criteria:

  • Inability to competently participate in study procedures

  • Concurrent upper extremity therapy, other neurological or psychiatric disorders

Study Design

Total Participants: 84
Treatment Group(s): 4
Primary Treatment: Magnetic Resonance Imaging
Phase:
Study Start date:
September 27, 2018
Estimated Completion Date:
December 31, 2024

Study Description

Ongoing research (NCT02098265) suggests that noninvasive EEG driven Brain Computer Interface (BCI) systems hold the potential for facilitating recovery in the chronic phase after stroke by synchronizing central or brain activity with peripheral movements and thereby harnessing brain plasticity.

The specific aims of this study are:

Aim 1: To investigate the efficacy of active FES vs. passive FES, as measured by changes in behavioral measures. The investigators hypothesize that improvements in motor function will be significantly greater using the active FES therapy than the passive FES therapy.

Aim 2: To investigate the relationship between brain functional activation patterns and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain fMRI and EEG measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Aim 3: To investigate the relationship between brain white matter integrity and behavior changes induced by active vs. passive FES intervention. The investigators hypothesize that changes induced by active FES (as measured by brain DTI measures) will show greater adaptive brain reorganization changes (i.e. brain changes that correlate with improved outcomes) than that induced by the passive FES.

Connect with a study center

  • University of Wisconsin

    Madison, Wisconsin 53706
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53706
    United States

    Site Not Available

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