Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Targeted Memory Reactivation (TMR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All phase TMR<br>TMR during every stage of sleep | Other: Targeted Memory Reactivation (TMR)<br>* 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.<br>|
| Experimental: Slow-wave sleep (SWS) only TMR<br>TMR during slow-wave sleep only | Other: Targeted Memory Reactivation (TMR)<br>* 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.<br>|
| Experimental: Reduced frequency TMR<br>TMR during only subset of sessions | Other: Targeted Memory Reactivation (TMR)<br>* 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.<br>|
| Sham Comparator: Sham TMR<br>Patients receive no TMR | Other: Targeted Memory Reactivation (TMR)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test (WMFT) | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep