Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Northwestern University70 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

Northwestern University

Chicago, Illinois, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: change from baseline at 6 weeks

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Central Contacts

Marc W Slutzky, MD/PhD

CONTACT

312-503-4653 mslutzky@northwestern.edu

Data from ClinicalTrials.gov

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