RecruitingNot ApplicableNCT03898804

An Early Feasibility Study of the ReHAB System

An Early Feasibility Study to Assess the Effects of the "Reconnecting the Hand and Arm to the Brain (ReHAB)" System


Sponsor

Jennifer Sweet, MD

Enrollment

12 participants

Start Date

Apr 9, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to examine the feasibility of a system that involves implanting small electrodes in the parts of the brain that control movement and sensation, and combining that with electrodes in the upper arm and shoulder to activate paralyzed muscles of the arm and hand. This system is intended for people with extensive paralysis in their arms. The small electrodes in the brain will be used to attempt to measure intended movements, and the muscles in the arm and hand will be stimulated to attempt to follow those intentions. The study is a prospective, non-randomized, open-label, exploratory safety/feasibility trial of up to 12 subjects. The Primary Endpoint will be evaluation over the first 13 months after implantation, after which the subjects will have the option of removal of the device or continued participation in a long-term study.


Eligibility

Min Age: 22 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BCI and FES for people with tetraplegia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBCI and FES

The intervention consists of surgical implantation of the device components, BCI and FES that will interface with computers that process and decode neural information, compute stimulation parameters, and control communication between the device components. The device will be tested during research sessions spanning a 13-month period.


Locations(1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

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NCT03898804


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