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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
An Early Feasibility Study of the ReHAB System
At a glance
Conditions
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.
Study leadership
- Jennifer Sweet, M.D. · PRINCIPAL_INVESTIGATOR · University Hospitals Cleveland Medical Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.