Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Sponsor
Northwestern University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04312269
Collaborator
(none)
70
1
4
57.2
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Targeted Memory Reactivation (TMR)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Outcomes assessors and participant are blinded to groups.
Primary Purpose:
Treatment
Official Title:
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Actual Study Start Date :
Feb 25, 2020
Anticipated Primary Completion Date :
Nov 1, 2024
Anticipated Study Completion Date :
Nov 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: All phase TMR

TMR during every stage of sleep

Other: Targeted Memory Reactivation (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.

Experimental: Slow-wave sleep (SWS) only TMR

TMR during slow-wave sleep only

Other: Targeted Memory Reactivation (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.

Experimental: Reduced frequency TMR

TMR during only subset of sessions

Other: Targeted Memory Reactivation (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.

Sham Comparator: Sham TMR

Patients receive no TMR

Other: Targeted Memory Reactivation (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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function [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.

  2. 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.

  3. Motor Activity Log (MAL) [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.

  4. 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.

  5. Modified Ashworth Scale [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.

  6. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Chicago Illinois United States 60611

Sponsors and Collaborators

  • Northwestern University

Investigators

  • Principal Investigator: Marc W Slutzky, MD/PhD, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marc Slutzky, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier:
NCT04312269
Other Study ID Numbers:
  • SP0052149
First Posted:
Mar 18, 2020
Last Update Posted:
Mar 28, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marc Slutzky, Associate Professor, Northwestern University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2022