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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BiCNS
DeviceSurgical implantation
Treatment groups
5 Participants
are divided into 1 treatment groupGroup A: Surgical implantation of BiCNSExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of BiCNS: The device is not explanted during 52-week study
This outcome will be considered successful if the device is not explanted during the 52-week period. Explantation of the device prior to the 52-week study period implies that the device is putting the subject at risk (e.g. through a serious infection at implantation site) and therefore must be removed.
Time frame
52 weeksSecondary outcomes
1
Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS
One or more participants demonstrate successful control of an assistive device using the action research arm test (ARAT). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3\) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1\) Performs test partially 0) Can perform no part of test
Time frame
52 weeks2
Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).
Intracortical microstimulation will be delivered to participants through the BiCNS device. The effect of ICMS will be measured based on participants' verbal reporting of what the stimuli feel like (quality of percepts) and where they appear to be coming from (location of percepts).
Time frame
52 weeksSponsors and contacts
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Source ClinicalTrials.gov