Actively Recruiting
Investigation on the Bidirectional Cortical Neuroprosthetic System
Led by Johns Hopkins University · Updated on 2025-09-09
5
Participants Needed
1
Research Sites
530 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of NeuroPort Microelectrode Array Systems and NeuroPort Electrodes (Sputtered Iridium Oxide Film), Patient Pedestals, the NeuroPort BioPotential Signal Processing System, and the CereStim C96 Programmable Stimulator. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.
CONDITIONS
Official Title
Investigation on the Bidirectional Cortical Neuroprosthetic System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 22 and 65 years
- Tetraplegia from C4-C6 spinal cord injury from any cause except neurodegenerative disease or active cancer
- Spinal cord injury classified as ASIA A, B, or C with fewer than three leg and foot muscle groups contractable
- Injury occurred more than one year prior to enrollment
- Life expectancy greater than 5 years
- Meets surgical safety criteria with clearance from healthcare providers
- Willing and able to give informed consent
- Stable psychosocial support system with caregiver available to monitor participant
- Able and willing to travel up to fifty miles to study site up to three days per week
- Able to understand and follow study instructions
- Pain well controlled without narcotic medications
- No other neurological or orthopedic conditions besides spinal cord injury
- Willing to participate and provide consent at time of study
You will not qualify if you...
- Impaired verbal communication skills
- Memory impairment on Rey Auditory Verbal Learning Test
- Intellectual impairment with MMSE score 26 or less or IQ less than 80
- Chronic psychiatric illness including psychosis or treatment-resistant depression
- Ventilator dependence
- Implanted devices incompatible with MRI, such as pacemakers or deep brain stimulators
- History of drug or alcohol dependence within past 24 months
- Cerebral lesions affecting frontal or parietal lobes
- Medical conditions contraindicating chronic implanted device surgery, such as diabetes or epilepsy
- Other unstable medical conditions like tremor or spasticity
- Anatomical or functional findings making safe implantation unlikely
- Prior cranioplasty
- Inability to undergo MRI or anticipated MRI need during study
- Active infections or unexplained fever
- Significant pulmonary, cardiovascular, or renal impairment making surgery unsafe
- Pregnancy, nursing, planning pregnancy, or inadequate birth control
- Corrected vision worse than 20/30
- HIV or AIDS infection
- Existing scalp lesions or skin breakdown
- Chronic use of steroids or immunosuppressive therapy
- Active cancer within past year or requiring chemotherapy
- Uncontrolled autonomic dysreflexia within past 3 months
- Implanted ventricular shunt
- Suicidal ideation within past 12 months
- Use of medications affecting neuroplasticity such as neuroleptics, benzodiazepines, or tricyclic antidepressants
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Neurology
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
N
Nathan E Crone, MD
CONTACT
F
Francesco Tenore, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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