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BiCNS Device for Quadriplegia (BiCNS Trial)
BiCNS Trial Summary
This trial is testing a new device that 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 the trial are to test the safety and efficacy of the device.
BiCNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBiCNS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BiCNS Trial Design
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Who is running the clinical trial?
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- Your vision is no worse than 20/30 after using corrective lenses.You are expected to live for more than 5 years.I have been cleared for surgery by my healthcare team.I rely on a machine to help me breathe.I have sores or broken skin on my scalp.I am not taking medications like neuroleptics, BDZ, or TCA.I only have a spinal cord injury, with no other neurological or orthopedic conditions.You have other ongoing health problems that are not well managed.I am not on long-term steroids or drugs that weaken my immune system.I have not had uncontrolled sudden high blood pressure in the last 3 months.My spinal cord injury is severe but I can move some leg muscles.You have difficulty with thinking or memory, or have a history of low intelligence test scores.I have brain lesions in the frontal and parietal areas.I don't have health issues that prevent surgery for implanting a device.My brain scans show it's too risky to place an implant where needed.I have had surgery to repair my skull.I do not have any active infections or unexplained fevers.I am living with HIV/AIDS.I have not had thoughts of suicide in the last year.I am willing and able to give my consent for treatment.I can travel up to 50 miles three times a week for the study.I agree to participate in the study and still want to at the start of it.You have trouble remembering things during a specific memory test called the Rey Auditory Verbal Learning Test.You have trouble understanding or expressing yourself with words.You have other health problems that could make it dangerous to put in the recording devices.I have tetraplegia between C4-C6 without neurodegenerative disease or active cancer.Your pain is managed well without strong pain medications.I have had cancer or needed chemotherapy in the last year.You have had a problem with drugs or alcohol in the past 2 years.You had a serious injury more than a year ago.You have a medical device inside your body that is not compatible with MRI scans, like a pacemaker or cochlear implant.You have long-term mental health issues like severe depression or psychosis.You have a ventricular shunt implanted in your body.
- Group 1: Surgical implantation of BiCNS
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies available in this trial at the moment?
"Affirmative. Clinicaltrials.gov indicates that the trial, which was posted on August 1st 2017 and recently modified on September 26th 2022, is currently seeking participants. Five individuals are needed to be recruited between two different sites."
Who qualifies to be an enrollee in this clinical trial?
"This research is seeking 5 people aged 22 to 65 who have quadriplegia. Patients must meet the following criteria: C4-C6 tetraplegia from non-degenerative or cancer causes, ASIA classification of A/B/C for those with fewer than three muscle groups in leg/foot, injury at least one year old, life expectancy of >5 years; surgical safety clearance; informed consent and stable psychosocial support system; ability to travel up to 50 miles 3x per week for duration of study; understanding and compliance w/ session instructions & well controlled pain without narcotics."
Is the enrollment of participants over seventy a requirement for this clinical trial?
"The acceptable age range for participants of this trial is between 22 and 65 years old."
How many subjects are participating in this clinical experiment?
"Affirmative. Per the information on clinicaltrials.gov, this investigation is actively enrolling volunteers to participate in it; which was initially uploaded on August 1st 2017 and recently modified on September 26th 2022. The trial requires 5 participants from 2 different centres."
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