Actively Recruiting
Cortical Recording and Stimulating Array Brain-Machine Interface
Led by Michael Boninger · Updated on 2025-10-20
30
Participants Needed
2
Research Sites
834 weeks
Total Duration
On this page
Sponsors
M
Michael Boninger
Lead Sponsor
U
University of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cortical Recording and Stimulating Array Brain-Machine Interface
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Intact limbs must have less than grade 2 strength in finger flexor and abduction on the side opposite the implant and a t-score <35 on PROMIS Upper Extremity Short Form
- Non-functional hand(s) may assist passively but must have no functional use as reported by the participant
- Unable to perform functional activities with the hand opposite the implant
- More than 1 year post-injury with no neurological worsening in past 6 months
- Age between 22 and 70 years at enrollment and study completion
- Live within 2 hours of the research site or willing to travel there at least once per week for training
- If living elsewhere, must stay within 2 hours of the site for at least 18 months after enrollment
- Ability to communicate in English
- Ability to understand study goals and follow simple instructions
- Normal results on neuropsychological and psychosocial assessments
- Ability to activate distinct brain areas during imagined or attempted movement tasks as shown by fMRI
- Stable psychosocial support and caregivers able to provide necessary daily care for skin and pedestal site, established for more than 6 months
- Life expectancy greater than 18 months
- Informed consent provided by participant or legal representative
- For transhumeral amputation, must have been evaluated and fit with an optimized prosthesis if appropriate
You will not qualify if you...
- Visual impairment limiting extended computer monitor use even with corrective lenses
- Serious diseases or disorders affecting ability to participate as determined by anesthesia evaluation
- Recent pressure sores that could worsen with bed rest
- Metallic implants prohibiting fMRI (excluding spinal fixators)
- Implantable generators such as pacemakers, spinal cord stimulators, cochlear implants, deep brain stimulators, vagus nerve stimulators, or defibrillators
- Women who are pregnant, lactating, or planning pregnancy within 25 months
- Allergy to contrast medium or kidney failure affecting MRI contrast use
- Chronic use of medications that impair motor or cognitive function
- Requirement for routine MRI, therapeutic ultrasound, or diathermy
- Osteomyelitis
- Severe scalp skin disorders causing lesions or breakdown
- History of myocardial infarction, cardiac arrest, or severe arrhythmias
- Implanted hydrocephalus shunt
- Stroke caused by surgical procedure
- Active infections or unexplained fever
- Consumption of more than one alcoholic drink per day on average
- Chronic use of steroids or immunosuppressive therapy
- Active cancer within past year except adequately treated skin cancers
- Uncontrolled insulin-dependent diabetes
- Uncontrolled autonomic dysreflexia in past 3 months
- Seizure disorders on anti-epileptic drugs or family history of seizures
- Suicide attempt within past 12 months
- Immunosuppression or immunocompromised conditions
- Previous neurosurgery affecting motor or sensory cortex likely impacting electrode viability
- Active psychiatric disorders including major depression, bipolar disorder, schizophrenia, PTSD
- Substance abuse within past 6 months
- Unsafe ambulation with frequent uncontrolled falls or injurious falls
- Plans to participate in contact or helmet-requiring sports
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
O
Olivia L Campbell
CONTACT
D
Debbie Harrington
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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