REINVENT: A Brain and Muscle Computer Interface for Stroke

Stroke Clinical Trial

— REINVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06285175
• Other study ID #: APP-22-04497
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: February 15, 2024

Study information

• Verified date: February 2024
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment - Upper Extremity	This assessment measures upper limb impairment after stroke	Through study completion, an average of 1 month
Primary	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
Primary	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