RecruitingNot ApplicableNCT03161067

Investigation on the Bidirectional Cortical Neuroprosthetic System

Sponsor

Johns Hopkins University

Enrollment

5 participants

Start Date

Aug 1, 2017

Study Type

INTERVENTIONAL

Conditions

Quadriplegia tetraplegia

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.

Eligibility

Min Age: 22 YearsMax Age: 65 Years

Inclusion Criteria12

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 study

Exclusion Criteria26

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
Cerebral lesions affecting frontal and parietal lobes
Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)
Other chronic, unstable medical conditions that could make control unsuitable (such as tremor or spasticity)
Presence of pre-surgical findings in anatomical, functional, and/or vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)
Prior cranioplasty
Inability to undergo MRI or anticipated need for an MRI during the study period
Participants with active infections or unexplained fever
Participants with other morbid conditions making the implantation of the recording elements unsafe; not limited to: significant pulmonary, cardiovascular, or renal impairments making the surgical procedure unsafe
Pregnancy (confirmation through blood test)
Nursing an infant, planning to become pregnant, or not using adequate birth control
Corrected vision no worse than 20/30
HIV or AIDS infection
Existing scalp lesions or skin breakdown
Chronic oral or intravenous use of steroids or immunosuppressive therapy
Active cancer within the past year or requires chemotherapy
Uncontrolled autonomic dysreflexia within the past 3 months
An implanted ventricular shunt
Suicidal ideation within the past 12 months
Medications that affect neuroplasticity: neuroleptics, Benzodiazepines (BDZ), Tricyclic Antidepressants (TCA).

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Interventions

DEVICEBiCNS

Surgical implantation

Locations(1)

Department of Neurology

Baltimore, Maryland, United States

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NCT03161067

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