StrokeNCT03401762
Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
A study testing MCI in people with Stroke and Stroke, Acute, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Stroke, Acute
- What is being tested?
- MCI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke participants
- Hemiparesis from first ever stroke at least 6 months prior to screening
- Severe motor impairment (FMA of 7-30)
- At least some voluntary shoulder and elbow muscle activation.
- Acute stroke participants
- Hemiparesis from first ever stroke within the past 21 days
- Severe motor impairment (FMA of 3-20), or total Manual Motor Score of 1-8 combined in Shoulder Abduction and Finger Extensors
Who cannot join
- Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
- Visual impairment (such as hemianopia) preventing full view of the screen
- Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
- Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
- Inability to understand or follow commands in English due to aphasia or other reason
- Diffuse or multifocal infarcts
- Substantial arm pain preventing participation for 90 minutes a day
- New spasticity treatment (pharmacological or Botox)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cynthia Gorski contact
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
About this study
The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.
Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.
This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.
- Conditions
- Stroke, Stroke, Acute
- Being tested
- MCI, Sham MCI
- Keywords
- rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCIBehavioural
EMG-controlled game
Sham MCIBehavioural
Sham control game
| Study group | Role | What they receive |
|---|---|---|
| Chronic stroke MCI Electromyogram (EMG) pairs | Experimental | Decoupling 2 muscles at a time with MCI Receives: Behavioral: MCI |
| Chronic stroke MCI EMG triplets | Experimental | Decoupling 3 muscles at a time with MCI Receives: Behavioral: MCI |
| Chronic stroke MCI while reaching | Experimental | Decoupling muscles with MCI while reaching to targets Receives: Behavioral: MCI |
| Chronic stroke Sham MCI | Sham comparator | Sham control group Receives: Behavioral: Sham MCI |
| Acute stroke MCI | Experimental | Decoupling muscles with MCI in acute stroke subjects Receives: Behavioral: MCI |
| Acute stroke Sham MCI | Sham comparator | Acute stroke subjects sham comparator Receives: Behavioral: Sham MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Timed
Measured: baseline to 6 weeks
Secondary outcomes (5)
Fugl-Meyer Assessment - Upper Extremity (UE)
Measured: baseline to 6 weeks
Motor Activity Log
Measured: baseline to 6 weeks
Modified Ashworth Scale
Total score
Measured: baseline to 6 weeks
Fugl-Meyer Assessment UE
Measured: baseline to 10 weeks
Wolf Motor Function Test
Timed
Measured: baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start15 Jan 2018
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Marc Slutzky, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03401762
- Sponsor's protocol ID
- STU00203644
- Status last verified
- Apr 2026
- First submitted
- 9 Jan 2018
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey RL, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2026 Jun 8:15459683261454937. doi: 10.1177/15459683261454937. Online ahead of print.
PubMed 42261097Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey R, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Function: a Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 25:2025.06.24.25330240. doi: 10.1101/2025.06.24.25330240.
PubMed 40666333Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. J Neuroeng Rehabil. 2024 Jan 20;21(1):11. doi: 10.1186/s12984-024-01305-0.
PubMed 38245730Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. Res Sq [Preprint]. 2023 Oct 9:rs.3.rs-3398815. doi: 10.21203/rs.3.rs-3398815/v1.
PubMed 37886579Hung NT, Paul V, Prakash P, Kovach T, Tacy G, Tomic G, Park S, Jacobson T, Jampol A, Patel P, Chappel A, King E, Slutzky MW. Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. Ann Clin Transl Neurol. 2021 Sep;8(9):1895-1905. doi: 10.1002/acn3.51442. Epub 2021 Aug 20.
PubMed 34415114
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable MCI to Reduce Muscle Co-activation in Acute and Chronic Stroke
- ClinicalTrials.gov ID
- NCT03401762
- Acronym / sponsor ID
- STU00203644
- Conditions
- Stroke, Stroke, Acute
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab, National Institutes of Health (NIH)
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to explore the feasibility of using a wearable device, called a myoelectric-computer interface (MCI), to improve arm movement in people who have had a stroke.
Impaired arm movement after stroke is caused not just by weakness, but also by impaired coordination between joints due to abnormal co-activation of muscles. These abnormal co-activation patterns are thought to be due to abnormal movement planning.The MCI aims to reduce abnormal co-activation by providing feedback about individual muscle activations.
This randomized, controlled, blinded study will test the home use of an MCI in chronic and acute stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Chronic stroke MCI Electromyogram (EMG) pairs | Experimental | Behavioral: MCIDecoupling 2 muscles at a time with MCI |
| Chronic stroke MCI EMG triplets | Experimental | Behavioral: MCIDecoupling 3 muscles at a time with MCI |
| Chronic stroke MCI while reaching | Experimental | Behavioral: MCIDecoupling muscles with MCI while reaching to targets |
| Chronic stroke Sham MCI | Sham comparator | Behavioral: Sham MCISham control group |
| Acute stroke MCI | Experimental | Behavioral: MCIDecoupling muscles with MCI in acute stroke subjects |
| Acute stroke Sham MCI | Sham comparator | Behavioral: Sham MCIAcute stroke subjects sham comparator |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Chronic stroke participants
- Hemiparesis from first ever stroke at least 6 months prior to screening
- Severe motor impairment (FMA of 7-30)
- At least some voluntary shoulder and elbow muscle activation.
- Acute stroke participants
Key exclusion criteria (8 listed)
- Cognitive impairment with at least moderately impaired attention, or unable to follow instructions of the MCI task
- Visual impairment (such as hemianopia) preventing full view of the screen
- Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest).
- Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study
- Inability to understand or follow commands in English due to aphasia or other reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCIEMG-controlled game | Behavioural | Acute stroke MCI, Chronic stroke MCI EMG triplets, Chronic stroke MCI Electromyogram (EMG) pairs, Chronic stroke MCI while reaching |
| Sham MCISham control game | Behavioural | Acute stroke Sham MCI, Chronic stroke Sham MCI |
Primary outcome
Wolf Motor Function Test
Time frame: baseline to 6 weeks
Timed
5 secondary outcomes
Fugl-Meyer Assessment - Upper Extremity (UE)
Time frame: baseline to 6 weeks
Motor Activity Log
Time frame: baseline to 6 weeks
Modified Ashworth Scale
Time frame: baseline to 6 weeks
Fugl-Meyer Assessment UE
Time frame: baseline to 10 weeks
Wolf Motor Function Test
Time frame: baseline to 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Derived from this study: PubMed 42261097Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey RL, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2026 Jun 8:15459683261454937. doi: 10.1177/15459683261454937. Online ahead of print.
- Derived from this study: PubMed 40666333Khorasani A, Gorski CM, Hung NT, Hulsizer J, Paul V, Tomic G, Prakash PR, Park S, Seo G, Houskamp EJ, Lanis J, Hunzeker M, King E, Chappel A, Jampol A, Patel P, Gallagher C, Galant R, Rucker G, Lee J, Harvey R, Roh J, Slutzky MW. Wearable Myoelectric Interface for Neurorehabilitation (MINT) to Recover Arm Function: a Randomized Controlled Trial. medRxiv [Preprint]. 2025 Jun 25:2025.06.24.25330240. doi: 10.1101/2025.06.24.25330240.
- Derived from this study: PubMed 38245730Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. J Neuroeng Rehabil. 2024 Jan 20;21(1):11. doi: 10.1186/s12984-024-01305-0.
- Derived from this study: PubMed 37886579Khorasani A, Hulsizer J, Paul V, Gorski C, Dhaher YY, Slutzky MW. Myoelectric interface for neurorehabilitation conditioning to reduce abnormal leg co-activation after stroke: a pilot study. Res Sq [Preprint]. 2023 Oct 9:rs.3.rs-3398815. doi: 10.21203/rs.3.rs-3398815/v1.
- Derived from this study: PubMed 34415114Hung NT, Paul V, Prakash P, Kovach T, Tacy G, Tomic G, Park S, Jacobson T, Jampol A, Patel P, Chappel A, King E, Slutzky MW. Wearable myoelectric interface enables high-dose, home-based training in severely impaired chronic stroke survivors. Ann Clin Transl Neurol. 2021 Sep;8(9):1895-1905. doi: 10.1002/acn3.51442. Epub 2021 Aug 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cynthia Gorski contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MCI in people with Stroke and Stroke, Acute, run by Northwestern University 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc W Slutzky, MD, PhD (3125034653, mslutzky@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: baseline to 6 weeks). 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 NCT03401762, 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 8 Apr 2026.