REINVENT: A Brain and Muscle Computer Interface for 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90033, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele-REINVENT

Other

Tele-REINVENT consists of EMG-biofeedback of the affected arm to control games on a computer screen.

Primary outcomes

Fugl Meyer Assessment - Upper Extremity

Time frame: Through study completion, an average of 1 month

This assessment measures upper limb impairment after stroke
Maximum EMG activity

Time frame: Through study completion, an average of 1 month

This assessment measures trace muscle activity in the affected limb during a controlled movement task
Corticomuscular coherence

Time frame: Through study completion, an average of 1 month

This assessment measures the connectivity between the brain and muscles of the affected side as a percentage.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Acronym: REINVENT

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2024
First posted: Feb 29, 2024
Registry last updated: Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed