BCI-FES System for Quadriplegia
(ReHAB Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial does not specify if you must stop taking your current medications, but it excludes those who use certain medications like sedatives, anticoagulants, steroids, or immunosuppressants regularly. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the BCI-FES treatment for quadriplegia?
Research shows that combining brain-computer interfaces (BCI) with functional electrical stimulation (FES) can improve hand function in people with tetraplegia, a condition similar to quadriplegia. Additionally, BCI technology has been used to help patients with neurological conditions regain some motor control and improve their quality of life.12345
Is the BCI-FES system safe for use in humans?
How is the BCI-FES treatment for quadriplegia different from other treatments?
The BCI-FES treatment is unique because it combines brain-computer interface (BCI) technology, which reads motor intent from the brain, with functional electrical stimulation (FES) to restore movement in paralyzed patients. This integration allows for more precise and intuitive control of movement compared to traditional therapies.168910
What is the purpose of this trial?
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.
Research Team
Jonathan P Miller, MD
Principal Investigator
University Hospitals Cleveland Medical Center
Eligibility Criteria
This trial is for adults aged 22-65 with stable tetraplegia from spinal cord injury or stroke, who live within a three-hour drive of the study site (or can relocate) and have a life expectancy over 13 months. Participants need intact brain motor areas, reliable communication ability, and a strong support system. They must not be pregnant, on certain medications, or have conditions that conflict with the study requirements.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation and Initial Testing
Surgical implantation of the ReHAB system and initial testing of the device
Device Testing and Evaluation
Participants undergo testing and evaluation of the implanted device for safety, tolerability, and efficacy
Follow-up
Participants are monitored for safety and effectiveness after the initial 13-month testing period
Long-term Extension (optional)
Participants may opt into a long-term study to continue using the device for up to 5 years
Treatment Details
Interventions
- BCI and FES
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Sweet, MD
Lead Sponsor
Jonathan Miller, MD
Lead Sponsor