NCT03898804 · Jennifer Sweet, MD
An Early Feasibility Study of the ReHAB System
(ReHAB)
What this study 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 treatment group$1 and shoulder to activate paralyzed muscles of the treatment group$1 and hand.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. .
- Ability to speak understandably or, if unable to speak understandably, a reliable means of yes/no communication.
- Life expectancy greater than 13 months.
- Chronic care environment within a three-hour drive of the study site or the ability to temporarily relocate to a residence within a three-hour drive of the study site.
- Willingness to remain available (geographically stable) for at least 13 months after enrollment, including maintenance of the evaluation schedule, frequent visits to the Investigator's office, and visits of Sponsor personnel to the subject's chronic care environment.
- Willingness to allow videotape recordings to be made of the surgical procedure (for training purposes) and portions of the Feasibility Evaluations.
- A stable psychosocial support system.
- Scalp devoid of any lesions or skin breakdown precluding surgery.
- Ability to provide voluntarily informed consent in accordance with Site institutional policies and willingness to release of Personal Health Information from the date of the injury or disease onset through the completion of the clinical Study.
- Availability of caregivers capable of providing the necessary daily care of the subject's skin and electrode externalization sites.
Exclusion criteria
- 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.
- Hydrocephalus requiring diversion of cerebrospinal fluid.
- Autonomic dysreflexia within three months prior to enrollment that required urgent evaluation and pharmacologic intervention prescribed by a physician.
- Seizure within 3 months prior to enrollment.
- Any medical condition expected to require routine MRI imaging or subjects with contraindication(s) to MRI.
- History of osteomyelitis or skin disorder that causes excessive skin sloughing, lesions or breakdown of the scalp.
- Chronic use of medications such as sedatives that may significantly retard motor coordination and cognitive ability.
- Chronic use of anticoagulant medications. (Subjects receiving prophylactic anticoagulation solely for the prevention of deep venous thrombosis are not excluded, but must be able to have their prophylactic anticoagulation suspended temporarily for the surgical procedure and immediate post-operative period.)
- Chronic use of steroids or immunosuppressant therapy.
- Active treatment for another serious medical, neurological or psychiatric disease or disorder that could seriously affect the subject's ability to undergo surgical implantation of the electrodes or participate in the testing sessions.
- Pregnant, lactating, or of childbearing age and not using adequate birth control.
- Active consumption of more than 1 alcoholic beverage per day.
- Suicide attempt within 12 months prior to enrollment.
- History of myocardial infarction or unstable cardiac arrhythmia.
- Enrollment in any other investigational study that may interfere with the time commitments required of this study.
- Subjects who are immunocompromised.
- Subjects who require ongoing diathermy or ultrasound treatments.
- Subjects with severe upper extremity joint contractures or Ashworth spasticity scores of 4 that would limit functional movements.
- Subjects who have contraindication(s) to CT.
- Subjects who are ventilator dependent. Subjects who are sometimes ventilator-assisted (for example, while sleeping) are not excluded.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2025 · Source of record for eligibility and locations