Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

NCT04312269 | Recruiting

• 1 other identifier: SP0052149
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function

  change from baseline at 6 weeks

• Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function

  change from baseline at 10 weeks

• Motor Activity Log (MAL)

  change from baseline at 6 weeks

• Motor Activity Log (MAL)

  change from baseline at 10 weeks

• Modified Ashworth Scale

  change from baseline at 6 weeks

Study Arms (4)

All phase TMR

EXPERIMENTAL

TMR during every stage of sleep

Other: Targeted Memory Reactivation (TMR)

Slow-wave sleep (SWS) only TMR

EXPERIMENTAL

TMR during slow-wave sleep only

Other: Targeted Memory Reactivation (TMR)

Reduced frequency TMR

EXPERIMENTAL

TMR during only subset of sessions

Other: Targeted Memory Reactivation (TMR)

Sham TMR

SHAM COMPARATOR

Patients receive no TMR

Other: Targeted Memory Reactivation (TMR)

Interventions

Targeted Memory Reactivation (TMR) OTHER

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.

All phase TMR; Reduced frequency TMR; Sham TMR; Slow-wave sleep (SWS) only TMR

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Marc W Slutzky, MD/PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc W Slutzky, MD/PhD

CONTACT

312-503-4653; mslutzky@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors and participant are blinded to groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 18, 2020
• Study Start: February 25, 2020
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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.

Locations

US (1)