A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tetraplegia
- Sponsor
- Michael Boninger
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- The primary outcome is the safety of the participant.
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
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.
Detailed Description
Individuals with severe paralysis have intact brain function but are unable to move due to injury or disease affecting the spinal cord, nerves or muscles. Brain-machine interface (BMI) technology is based on the finding that with intact brain function, neural (nerve) signals are generated even though they do not reach the arms, hands and legs. By placing (implanting) sensors on the surface of the brain, individuals can be trained to send neural signals which are interpreted by a computer and translated to movement which can then be used to control a variety of devices or computer displays. Using neural activity to control an external device is referred to as a brain-machine interface (BMI) technology. In addition, areas of the brain that are involved in interpreting sensations from the arms, hands and legs remain functional after injury. It is therefore possible to send tiny electrical pulses through implanted arrays to mimic sensory input that would normally come from the arms, hands and legs. The investigators refer to this as "microstimulation."
Investigators
Michael Boninger
Principal Investigator / Sponsor-Investigator
University of Pittsburgh
Eligibility Criteria
Inclusion Criteria
- •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.
- •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.
- •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.
- •Subjects must be able to communicate with the investigators in English because of the need to follow the instructions of the study team.
- •Subjects must show an understanding of the study goals and have the ability to follow simple directions as judged by the investigators
- •Subjects must have results that are within normal limits on neuropsychological and psychosocial assessment; psychosocial health and support will be assessed by interview with the psychologist.
- •Subjects must be able to activate distinct cortical areas during imagined or attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this will be evaluated with functional magnetic resonance imaging (fMRI) as part of screening.
Exclusion Criteria
- •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
- •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
- •Women of childbearing age who are pregnant, lactating, or plan to become pregnant during the next 25 months
- •Allergy to contrast medium or kidney failure that could be exacerbated by contrast agent (for MRI)
- •Subjects receiving medications (such as sedatives) chronically that may retard motor coordination and cognitive ability
- •Individuals who require routine MRI, therapeutic ultrasound, or diathermy
- •Individuals with osteomyelitis
Outcomes
Primary Outcomes
The primary outcome is the safety of the participant.
Time Frame: One year following array implantation
This measure will be considered a success if the device is not removed for safety reasons during the 12-month post-implant evaluation.
Secondary Outcomes
- The secondary outcome is the efficacy of the electrodes for long-term recording of neural activity and successful control of external devices.(One year following array implantation)