An Early Feasibility Study of the ReHAB System
ConditionTetraplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorJennifer Sweet, MD
About 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.
Eligibility criteria
Qualifiers
Age between 22 and 65 years of age.
Tetraplegia due to a static identified disease process (spinal cord injury or stroke) that prevents functional activity of the upper extremity.
Onset of tetraplegia at least 12 months prior to enrollment, with stability of weakness for at least 3 months.
Must have sufficiently intact cortical motor structures and stable medical prognoses to be able to perform the BCI control tasks for at least one year. .
Disqualifiers
Presence of an implanted stimulator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator, vagus nerve stimulator, or defibrillator. (Implanted intrathecal pumps for pain or spasticity, cough implants, or diaphragmatic pacers are not excluded.)
Any active infection(s) or unexplained fever.
Active cancer within the one year prior to enrollment (other than adequately treated basal or squamous cell skin cancer).
Uncontrolled insulin-dependent diabetes mellitus.
Trial design
Treatments tested in this trial
- BCI and FES
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Jennifer Sweet, MD
Lead sponsor
University Hospitals Cleveland Medical Center
Sponsor institution
Source ClinicalTrials.gov