Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

October 20, 2025 updated by: University of Wisconsin, Madison

Stroke Rehabilitation Using BCI Technology

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 upper extremity 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 Criteria:

  • Inability to competently participate in study procedures
  • Concurrent upper extremity therapy, other neurological or psychiatric disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Passive FES
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.
Device: Functional Electric Stimulation (FES)
FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
Behavioral: Behavioral Assessments
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
Other: Magnetic Resonance Imaging
A functional magnetic resonance image will be collected.
Experimental: Active FES
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.
Device: Functional Electric Stimulation (FES)
FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
Behavioral: Behavioral Assessments
These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
Other: Magnetic Resonance Imaging
A functional magnetic resonance image will be collected.
Other: EEG
EEG electrodes will be attached to the subject's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
Other Names:
  • Electroencephalography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Action Research Arm Test Scores
Time Frame: baseline, 7 weeks, 10 weeks, 4 months
The Action Research Arm Test (ARAT) is designed for evaluation of upper extremity function. This test consists of sections for Grasp, Grip, Pinch and Gross Movements and comprise a total of 19 tests. Each test is scored 0-3 where 0 is 'no movement' and 3 is 'the movement is performed normally'. Each section is scored separately and the scores added for a total possible range of scores from 0-57 where the higher the score, the complete and efficient the movement. Scores will be reported for baseline, mid (~7 weeks), post (~10 weeks), and end of study, up to 4 months.
baseline, 7 weeks, 10 weeks, 4 months
Stroke Impact Scale
Time Frame: baseline, 7 weeks, 10 weeks, 4 months
The Stroke Impact Scale, or SIS, was created to assess changes in impairments, activities and participation following a stroke. Scores on the SIS will provide an index of clinically "meaningful" change representing the change in the patient's mental and physical abilities concurrent with their performance on the verbal fluency and memory tasks. The 4 physical function domains (strength, hand function, activities of daily living (ADL)/instrumental activities of daily living (IADL), and mobility) will be collapsed to a physical function subscale. All domain scores range from 0 to 100 with 100 being the best.
baseline, 7 weeks, 10 weeks, 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Modified Ashworth Scale (MAS)
Time Frame: 4 months
The MAS measures spasticity where 0 is no increase in muscle tone to 4 where affected part is in rigid in flexion or extension. Assessed at 5 time points over the length of the study.
4 months
Change in Electroencephalogram (EEG) Response Strength
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
EEG was recorded in microvolts (µV) from electrodes C4/C3 during periods of left arm imagery and right arm imagery. EEG Response strength is defined as the spectral power in the mu + beta frequency band (8-30 Hz), averaged over the BCI trials. For each participant and time point, a ratio was computed: Ratio = Power_Left Imagery / Power_Right Imagery.
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Signal Change in Functional Magnetic Resonance Imaging (MRI)
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
To compare the percent signal change in the functional MRI activations before and after functional stimulation.
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Nine Hole Peg Test (9HPT)
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
The 9-HPT is a quick and easy to administer tool for screening fine motor problems in participants. It is a timed test in which nine pegs are inserted and removed from nine holes in the pegboard with each hand. Measured at 5 time points over the length of the study.
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Motor Activity Log (MAL): Amount of Use
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Amount of Use scoring is as follows (intermediate scores are possible, 0.5 between each whole number):

  • 0 - Did not use my weaker arm (not used).
  • 1 - Occasionally used my weaker arm, but only very rarely (very rarely).
  • 2 - Sometimes used my weaker arm but did the activity most of the time with my stronger arm (rarely).
  • 3 - Used my weaker arm about half as much as before the stroke (half pre-stroke).
  • 4 - Used my weaker arm almost as much as before the stroke (3/4 pre-stroke).
  • 5 - Used my weaker arm as often as before the stroke (same as pre-stroke).
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Motor Activity Log (MAL): Quality of Movement
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

The MAL is a structured interview developed to assess the use of the more affected upper extremity (UE) in real-world daily activities. Assessed at 5 time points over the length of the study. The Quality of Movement was scored as follows (intermediate scores 0.5 between whole numbers are possible):

  • 0 - The weaker arm was not used at all for that activity (never).
  • 1 - The weaker arm was moved during that activity but was not helpful (very poor).
  • 2 - The weaker arm was of some use during that activity but needed some help from the stronger arm or moved very slowly or with difficulty (poor).
  • 3 - The weaker arm was used for the purpose indicated but movements were slow or were made with only some effort (fair).
  • 4 - The movements made by the weaker arm were almost normal, but were not quite as fast or accurate as normal (almost normal).
  • 5 - The ability to use the weaker arm for that activity was as good as before the stroke (normal).
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Hand Grip Strength
Time Frame: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.
baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: 4 months
The CES-D is a self-report scale and includes 20 items that survey mood, somatic complaints, interactions with others, and motor functioning in the past week. Total possible score 0-60, with the higher score indicating more symptoms of depression. Assessed at 5 time points over the length of the study.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Vivek Prabhakaran, MD, PhD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2018

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

October 15, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Estimated)

November 4, 2025

Last Update Submitted That Met QC Criteria

October 20, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0971
  • A539300 (Other Identifier: UW Madison)
  • 1R01NS105646-01A1 (U.S. NIH Grant/Contract)
  • SMPH/RADIOLOGY (Other Identifier: UW Madison)
  • Protocol Version 2/1/22 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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