RecruitingTetraplegiaSpinal Cord InjuryBrainstem Stroke
Cortical Recording and Stimulating Array Brain-Machine Interface
Eligible age
22–70 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
The purpose of this research study is to demonstrate the safety and efficacy of using two CRS Arrays (microelectrodes) for long-term recording of brain motor cortex activity and microstimulation of brain sensory cortex.
Sponsor: Michael Boninger
You may qualify if…
- ✓ 1. Subjects must have limited or no ability to use one or both hands due to cervical spinal cord injury, brainstem stroke, brachial plexus injury, above-elbow amputation, or spinal stroke. Individuals with intact limbs must have less than grade 2 strength in finger flexor and abduction on the contralateral side to the implant and a t-score \<35 on the PROMIS Upper Extremity Short Form. The non-functional hand(s) may be involved passively in functional tasks; for example, pushing an object or passively grasping an object placed into the hand. However, the participant must report that they have no functional use of their hand(s).
- ✓ 2. Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.
- ✓ 3. Subjects must be over 1 year post-injury at time of implantation. In addition, subject must report no worsening in neurologic status (strength, sensation) for the previous 6 months.
- ✓ 4. Subjects must be between the ages of 22-70 years old at the time of enrollment and completion of the study. Participants outside this age range may be at an increased surgical risk and increased risk of fatigue during BMI training.
- ✓ 5. Subjects must live within 2 hours of the research site during the study or be willing to travel to the research site at least once per week for BMI training.
- ✓ 6. If subjects do not live in the area, they are expected to stay somewhere within 2 hours of the research site for at least 18 months after enrollment.
- ✓ 7. Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
- ✓ 8. Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators
You may not qualify if…
- ✕ 1. Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
- ✕ 2. Another serious disease(s) or disorder(s) that could affect ability to participate in this study (verified during pre-op anesthesia evaluation to determine surgical risk status)
- ✕ 3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest
- ✕ 4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal fixators are generally non-ferrous and would not exclude someone from participating in the study
- ✕ 5. Any type of implantable generator such as a pacemaker, spinal cord stimulator, cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or defibrillator
- ✕ 6. Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months
- ✕ 7. Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)
- ✕ 8. Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability
Where it's recruiting
Illinois
Chicago
Pennsylvania
Pittsburgh
Source: ClinicalTrials.gov · NCT01894802 · last updated 2026-05-20