Investigation on the Bidirectional Cortical Neuroprosthetic System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorJohns Hopkins University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- BiCNS
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov