Cortical Recording and Stimulating Array Brain-Machine Interface
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorMichael Boninger
About this trial
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.
Eligibility criteria
Qualifiers
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).
Subjects must report that they are unable to perform functional activities with the hand contralateral to implantation.
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.
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.
Disqualifiers
Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses
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)
Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest
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
Trial design
Treatments tested in this trial
- Implantation of CRS Arrays
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Michael Boninger
Lead sponsor
University of Pittsburgh
Sponsor institution
University of Chicago
Collaborator
Carnegie Mellon University
Collaborator
Northwestern University
Collaborator
Sinai Health System
Collaborator
Source ClinicalTrials.gov