Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Targeted Memory Reactivation (TMR)

• Registration Number: NCT04312269
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-03-09
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Slow-wave sleep (SWS) only TMR	Targeted Memory Reactivation (TMR)	TMR during slow-wave sleep only
Reduced frequency TMR	Targeted Memory Reactivation (TMR)	TMR during only subset of sessions
Sham TMR	Targeted Memory Reactivation (TMR)	Patients receive no TMR
All phase TMR	Targeted Memory Reactivation (TMR)	TMR during every stage of sleep

Primary Outcome Measures

Name	Time	Method
Wolf Motor Function Test (WMFT)	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.

Secondary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function	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.
Motor Activity Log (MAL)	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.
Modified Ashworth Scale	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.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States