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StrokeNCT04141774

Stroke Rehabilitation Using Brain-Computer Interface (BCI) Technology

A study testing Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
27 Sep 2018to 31 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53706

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Stroke
Being tested
Functional Electric Stimulation (FES), Behavioral Assessments, Magnetic Resonance Imaging, EEG
Keywords
aneurysm, transient ischemic attack
Medical subject headings
Stroke, Aneurysm, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Electric Stimulation (FES)Device

    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 AssessmentsBehavioural

    These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.

  • Magnetic Resonance ImagingOther

    A functional magnetic resonance image will be collected.

  • EEGOther

    Also called Electroencephalography

    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.

Study groups in NCT04141774
Study groupRoleWhat they receive
Passive FESActive comparatorSubjects 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.
Receives: Device: Functional Electric Stimulation (FES); Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging
Active FESExperimentalSubjects 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.
Receives: Device: Functional Electric Stimulation (FES); Behavioral: Behavioral Assessments; Other: Magnetic Resonance Imaging; Other: EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Action Research Arm Test Scores

    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.

    Measured: baseline, 7 weeks, 10 weeks, 4 months

  2. Stroke Impact Scale

    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.

    Measured: baseline, 7 weeks, 10 weeks, 4 months

Secondary outcomes (8)

  1. Change in Electroencephalogram (EEG) Response Strength

    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.

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  2. Signal Change in Functional Magnetic Resonance Imaging (MRI)

    To compare the percent signal change in the functional MRI activations before and after functional stimulation.

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  3. Nine Hole Peg Test (9HPT)

    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.

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  4. Motor Activity Log (MAL): Amount of Use

    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).

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  5. Motor Activity Log (MAL): Quality of Movement

    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).

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  6. Change in Modified Ashworth Scale (MAS)

    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.

    Measured: 4 months

  7. Hand Grip Strength

    Hand Grip Strength will be assessed using a dynamometer. Measured at 5 time points over the length of the study.

    Measured: baseline 1, baseline 2, 7 weeks, 10 weeks, 4 months

  8. Center for Epidemiologic Studies Depression Scale (CES-D)

    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.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2019
  2. Study start27 Sep 2018
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04141774
Sponsor's protocol ID
2018-0971
Other IDs
1R01NS105646-01A1, A539300, SMPH/RADIOLOGY, Protocol Version 2/1/22
Status last verified
Oct 2025
First submitted
15 Oct 2019
Last updated
4 Nov 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Young BM, Stamm JM, Song J, Remsik AB, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Brain-Computer Interface Training after Stroke Affects Patterns of Brain-Behavior Relationships in Corticospinal Motor Fibers. Front Hum Neurosci. 2016 Sep 16;10:457. doi: 10.3389/fnhum.2016.00457. eCollection 2016.

    PubMed 27695404

  • Young BM, Nigogosyan Z, Walton LM, Remsik A, Song J, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Dose-response relationships using brain-computer interface technology impact stroke rehabilitation. Front Hum Neurosci. 2015 Jun 23;9:361. doi: 10.3389/fnhum.2015.00361. eCollection 2015.

    PubMed 26157378

  • Song J, Nair VA, Young BM, Walton LM, Nigogosyan Z, Remsik A, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology. Front Hum Neurosci. 2015 Apr 27;9:195. doi: 10.3389/fnhum.2015.00195. eCollection 2015.

    PubMed 25964753

  • Song J, Young BM, Nigogosyan Z, Walton LM, Nair VA, Grogan SW, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. Characterizing relationships of DTI, fMRI, and motor recovery in stroke rehabilitation utilizing brain-computer interface technology. Front Neuroeng. 2014 Jul 29;7:31. doi: 10.3389/fneng.2014.00031. eCollection 2014.

    PubMed 25120466

  • Young BM, Nigogosyan Z, Nair VA, Walton LM, Song J, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Case report: post-stroke interventional BCI rehabilitation in an individual with preexisting sensorineural disability. Front Neuroeng. 2014 Jun 24;7:18. doi: 10.3389/fneng.2014.00018. eCollection 2014.

    PubMed 25009491

Questions about this trial

What is this clinical trial studying?

A study testing Functional Electric Stimulation (FES), Behavioral Assessments and Magnetic Resonance Imaging in people with Stroke, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Action Research Arm Test Scores (time frame: baseline, 7 weeks, 10 weeks, 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04141774, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.

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Clinical Trial NCT04141774 | AzTrials