Actively Recruiting
An Early Feasibility Study of the ReHAB System
Led by Jennifer Sweet, MD · Updated on 2025-07-16
12
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Early Feasibility Study of the ReHAB System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 65 years
- Tetraplegia caused by a stable disease process such as spinal cord injury or stroke
- Paralysis onset at least 12 months before enrollment with weakness stable for at least 3 months
- Sufficiently intact brain motor areas and stable health to perform BCI control tasks for at least one year
- Ability to communicate with understandable speech or reliable yes/no method
- Life expectancy greater than 13 months
- Access to chronic care within three hours of the study site or ability to relocate temporarily nearby
- Willingness to remain geographically stable and available for frequent visits over 13 months
- Consent to videotaping of surgery and evaluations
- Stable psychosocial support system
- Scalp free of lesions or skin breakdown preventing surgery
- Ability to give informed consent and release personal health information
- Availability of caregivers for daily skin and electrode care
You will not qualify if you...
- Presence of implanted stimulators like pacemakers, spinal cord stimulators, cochlear implants, deep brain stimulators, vagus nerve stimulators, or defibrillators
- Active infections or unexplained fever
- Active cancer within one year before enrollment (except treated basal or squamous cell skin cancer)
- Uncontrolled insulin-dependent diabetes
- Hydrocephalus requiring cerebrospinal fluid diversion
- Autonomic dysreflexia needing urgent treatment within 3 months before enrollment
- Seizure within 3 months before enrollment
- Medical conditions requiring routine MRI or contraindicated for MRI
- History of scalp skin disorders causing lesions or breakdown
- Chronic use of sedatives affecting motor and cognitive abilities
- Chronic use of anticoagulants unless temporarily suspended for surgery
- Chronic use of steroids or immunosuppressants
- Active treatment for serious medical, neurological, or psychiatric disorders affecting participation
- Pregnant, breastfeeding, or of childbearing potential without adequate birth control
- Consuming more than one alcoholic beverage daily
- Suicide attempt within 12 months before enrollment
- History of heart attack or unstable heart rhythm
- Participation in other studies interfering with this trial
- Immunocompromised status
- Need for ongoing diathermy or ultrasound treatments
- Severe joint contractures or high spasticity limiting movement
- Contraindications to CT scans
- Ventilator-dependent individuals (except occasional ventilator assistance during sleep)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
J
Jennifer Sweet, M.D.
CONTACT
M
Mario Beccera, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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