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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Implantation of CRS Arrays
DeviceTwo Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Brain-Machine Interface UsersExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome is the safety of the participant.
This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.
Time frame
One year following array implantationSecondary outcomes
1
The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.
The efficacy of the CRS Arrays will be determined through a variety of measures, including characterization of signal quality, degrees of freedom achieved and subject performance.
Time frame
One year following array implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
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