Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Stroke Clinical Trial

Official title:

Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04312269
• Other study ID #: SP0052149
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2020
• Est. completion date: August 30, 2025

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Marc W Slutzky, MD/PhD
• Phone: 312-503-4653
• Email: mslutzky[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	change from baseline at 6 weeks
Secondary	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.	change from baseline at 10 weeks
Secondary	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.	change from baseline at 6 weeks
Secondary	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.	change from baseline at 10 weeks
Secondary	Modified Ashworth Scale	The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.	change from baseline at 6 weeks
Secondary	Modified Ashworth Scale	The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.	change from baseline at 10 weeks