- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04312269
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
May 25, 2026 updated by: Marc Slutzky, Northwestern University
This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors.
The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
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 Contact
- Name: Marc W Slutzky, MD/PhD
- Phone Number: 312-503-4653
- Email: mslutzky@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
-
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
21 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age at enrollment is 21 or older
- Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening
- Severe to moderate motor impairment (FMA-UE of 7-40)
- At least some voluntary shoulder and elbow muscle activation
Exclusion Criteria:
- Inability to follow instructions of the MyoCI task
- Visual impairment (such as hemianopia) preventing full view of 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 in both hemispheres
- Substantial arm pain preventing participation for 90 minutes a day
- Spasticity treatment (pharmacological or Botox) within last 3 months
- Ferromagnetic implants that are MRI incompatible
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All phase TMR
TMR during every stage of sleep
|
Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
|
|
Experimental: Slow-wave sleep (SWS) only TMR
TMR during slow-wave sleep only
|
Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
|
|
Experimental: Reduced frequency TMR
TMR during only subset of sessions
|
Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
|
|
Sham Comparator: Sham TMR
Patients receive no TMR
|
Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wolf Motor Function Test (WMFT)
Time Frame: change from baseline at 6 weeks
|
The WMFT evaluates upper extremity function on a continuous scale.
It measures the time it takes to perform 15 different tasks, with a time limit of 120 s per task.
|
change from baseline at 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
Time Frame: change from baseline at 6 weeks
|
The FMA-UE is a measure of impairment.
Maximum score is 66 on the motor function portion.
Items are scored on a 3-point ordinal scale.
|
change from baseline at 6 weeks
|
|
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
Time Frame: change from baseline at 10 weeks
|
The FMA-UE is a measure of impairment.
Maximum score is 66 on the motor function portion.
Items are scored on a 3-point ordinal scale.
|
change from baseline at 10 weeks
|
|
Motor Activity Log (MAL)
Time Frame: change from baseline at 6 weeks
|
The MAL is a validated measure of home-based arm function, both quantity and quality of use in 30 different activities of daily living.
|
change from baseline at 6 weeks
|
|
Motor Activity Log (MAL)
Time Frame: change from baseline at 10 weeks
|
The MAL is a validated measure of home-based arm function, both quantity and quality of use in 30 different activities of daily living.
|
change from baseline at 10 weeks
|
|
Modified Ashworth Scale
Time Frame: change from baseline at 6 weeks
|
The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.
|
change from baseline at 6 weeks
|
|
Modified Ashworth Scale
Time Frame: change from baseline at 10 weeks
|
The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.
|
change from baseline at 10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marc W Slutzky, MD/PhD, Northwestern University
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)
February 25, 2020
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
January 30, 2027
Study Registration Dates
First Submitted
March 9, 2020
First Submitted That Met QC Criteria
March 16, 2020
First Posted (Actual)
March 18, 2020
Study Record Updates
Last Update Posted (Actual)
May 27, 2026
Last Update Submitted That Met QC Criteria
May 25, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP0052149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Clinical functional outcomes and analyzed EMG (co-activation) will be uploaded and shared upon publication.
IPD Sharing Time Frame
IPD and associated analytic code will be made available upon publication of research results and will remain available for the duration of the funded project.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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