Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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
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
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Marc W Slutzky, MD/PhD, Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SP0052149
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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