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Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted Memory Reactivation (TMR)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Sleep

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

All phase TMR

Slow-wave sleep (SWS) only TMR

Reduced frequency TMR

Sham TMR

Arm Description

TMR during every stage of sleep

TMR during slow-wave sleep only

TMR during only subset of sessions

Patients receive no TMR

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
Modified Ashworth Scale
The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.
Modified Ashworth Scale
The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.

Full Information

First Posted
March 9, 2020
Last Updated
April 19, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT04312269
Brief Title
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Official Title
Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 25, 2020 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes assessors and participant are blinded to groups.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All phase TMR
Arm Type
Experimental
Arm Description
TMR during every stage of sleep
Arm Title
Slow-wave sleep (SWS) only TMR
Arm Type
Experimental
Arm Description
TMR during slow-wave sleep only
Arm Title
Reduced frequency TMR
Arm Type
Experimental
Arm Description
TMR during only subset of sessions
Arm Title
Sham TMR
Arm Type
Sham Comparator
Arm Description
Patients receive no TMR
Intervention Type
Other
Intervention Name(s)
Targeted Memory Reactivation (TMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
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 Outcome Measure Information:
Title
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
Description
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
Title
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
Description
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
Title
Motor Activity Log (MAL)
Description
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
Title
Motor Activity Log (MAL)
Description
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
Title
Modified Ashworth Scale
Description
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
Title
Modified Ashworth Scale
Description
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 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc W Slutzky, MD/PhD
Phone
312-503-4653
Email
mslutzky@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc W Slutzky, MD/PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

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