REINVENT: A Brain and Muscle Computer Interface for Stroke (REINVENT)

REINVENT: A Brain and Muscle Computer Interface for People With Severe Stroke

Stroke is a leading cause of adult disability in the United States. High doses of repeated task-specific practice have shown promising results in restoring upper limb function in chronic stroke (>6 months after onset). However, it is currently challenging to provide such doses in standard clinical practice. At-home telerehabilitation services supervised by a clinician are a potential solution to provide higher-dose interventions. However, telerehabilitation systems developed for repeated task-specific practice typically require a minimum level of active movement. Therefore, severely impaired people necessitate alternative therapeutic approaches. Measurement and feedback of electrical muscle activity via electromyography (EMG) have been previously implemented in the presence of minimal or no volitional movement to improve motor performance in people with stroke. Specifically, muscle neurofeedback training to reduce unintended co-contractions of the impaired hand may be a targeted intervention to improve motor control in severely impaired populations. In this study, we examine the effects of a low-cost, portable, and modular EMG biofeedback system (Tele-REINVENT) for supervised and unsupervised upper limb telerehabilitation after stroke during a 6-week home-based training program that reinforces activity of the wrist extensor muscles while avoiding coactivation of flexor muscles via computer games.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Tele-REINVENT

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Moderate to severe upper extremity hemiparesis and residual hand function (e.g., less than 20 degrees of active wrist or finger extension and enough muscle activity to measure with electromyography).

Exclusion Criteria:

• Taking anti-spasticity medication
• Significant vision loss (corrected vision is acceptable)
• Receptive aphasia
• Hand contractures
• Secondary neurological disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-REINVENT; All participants in this study are asked to use tele-REINVENT, a 6 week home tele-rehab program with EMG biofeedback.	Other: Tele-REINVENT; Tele-REINVENT consists of EMG-biofeedback of the affected arm to control games on a computer screen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment - Upper Extremity	This assessment measures upper limb impairment after stroke	Through study completion, an average of 1 month
Maximum EMG activity	This assessment measures trace muscle activity in the affected limb during a controlled movement task	Through study completion, an average of 1 month
Corticomuscular coherence	This assessment measures the connectivity between the brain and muscles of the affected side as a percentage.	Through study completion, an average of 1 month

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): February 15, 2024

Study Registration Dates

• First Submitted: September 28, 2022
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: APP-22-04497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No