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New treatment option for Tetraplegia
Official title Investigation on the Bidirectional Cortical Neuroprosthetic System
ClinicalTrials.gov ID: NCT03161067
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 65
You may be able to join if
- Participants must meet all , verified by medical evaluation, psychological evaluation, and review of medical history. 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...
- Injury more than one year prior to enrollment
- Participant has a life expectancy of greater than 5 years
You likely can't join if
- All interested participants will be reviewed for the presence of exclusion criteria by medical evaluation, review of medical history, self (or...
- 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...
- Ventilator dependent
See the full eligibility criteria
Who can join
- Participants must meet all , verified by medical evaluation, psychological evaluation, and review of medical history. 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.