RecruitingTetraplegiaQuadriplegia
Investigation on the Bidirectional Cortical Neuroprosthetic System
Eligible age
22–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ Participants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria include:
- ✓ Participants with C4-C6 tetraplegia from any etiology except neurodegenerative disease (e.g. amyotrophic lateral sclerosis) or active cancer.
- ✓ Complete or incomplete spinal cord injury classified by the American Spinal Injury Association (ASIA) as A or B or C if fewer than three muscle groups in the leg and foot (as identified in the ASIA Impairment Scale) can be contracted
- ✓ Injury more than one year prior to enrollment
- ✓ Participant has a life expectancy of greater than 5 years
- ✓ Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
- ✓ Willingness and ability to provide informed consent
- ✓ Screened by rehabilitation psychologist with a result showing that the participant has a stable psychosocial support system with caregiver capable of monitoring participant throughout the study
You may not qualify if…
- ✕ All interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or assistant) report and evaluation by a psychologist. Presence of any of the following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:
- ✕ Neurological conditions: Impaired receptive and/or expressive verbal communication skills
- ✕ Presence of memory impairment on the Rey Auditory Verbal Learning Test
- ✕ Intellectual impairment: score of 26 or less on the Mini-Mental State Examination or history of Intelligence Quotient \< 80
- ✕ Chronic psychiatric illness, including psychosis and treatment-resistant major depression, as indicated by a diagnosis of Axis I or Axis II on the Symptom Checklist-90-Revised Test
- ✕ Ventilator dependent
- ✕ Implanted devices such as: pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, cochlear implants or any other implantable device incompatible with MRI.
- ✕ History of drug or alcohol dependence in past 24 months
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT03161067 · last updated 2025-09-09