Early Feasibility Study of the ReHAB System for Tetraplegia

This study is testing a new system called ReHAB for people with tetraplegia (paralysis affecting all four limbs). The ReHAB system involves surgically placing small electrodes in the brain to measure intended movements, and other electrodes in the arm and shoulder to stimulate paralyzed muscles. The goal is to help you move your own arm and hand by connecting your brain activity to your muscles. This study will enroll up to 12 participants aged 22 to 65 who have had tetraplegia for at least 12 months. The main goal is to see how safe the ReHAB system is by tracking any side effects over 13 months.

Study design
This is an exploratory safety and feasibility study that will enroll up to 12 participants. It is not randomized and is open-label, meaning everyone knows what treatment is being given.
What's involved
The intervention involves surgical implantation of device components. Adverse events will be measured at 13 months.
Compensation
Not stated in the trial record.
Follow-up
The study will track treatment-related adverse events for 13 months after the intervention.

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NCT03898804

An Early Feasibility Study of the ReHAB System

Recruiting
NAAges 22–65InterventionalDevice feasibility
University Hospitals Cleveland Medical Center
~12 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:BCI and FES

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-related adverse events
Measured over 13 months
Tetraplegia

NCT03898804

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jennifer Sweet, M.D. · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center

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  • Incidence of treatment-related adverse events13 months

    Successful implantation of brain and extremity recording/stimulating electrodes for 1 year without explantation or device-related serious adverse events.