Investigation on the Bidirectional Cortical Neuroprosthetic System (NCT03161067) | Clinical Trial Compass
RecruitingNot Applicable
Investigation on the Bidirectional Cortical Neuroprosthetic System
United States5 participantsStarted 2017-08-01
Plain-language summary
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.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion Criteria:
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
* Ability and willingness to travel to up to fifty miles to study location up to three days per week for the duration of the study
* Ability to understand and comply with study session instructions
* Pain well controlled without narcotic medications
* No other neurological, orthopedic conditions beyond the spinal cord injury
* Participant consents to the study and still wishes to participate at the time of the…
What they're measuring
1
Safety of BiCNS: The device is not explanted during 52-week study