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Neuroprosthetic Device

BiCNS Device for Quadriplegia (BiCNS Trial)

N/A
Recruiting
Led By Pablo A Celnik, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
No other neurological, orthopedic conditions beyond the spinal cord injury
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights

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.

Who is the study for?
This trial is for individuals with C4-C6 tetraplegia, not due to neurodegenerative disease or active cancer. They must have had the injury for over a year, expect to live more than 5 years, and be able to travel to the study site regularly. Participants need stable support systems and cannot be on narcotics or have other major health issues that could interfere.Check my eligibility
What is being tested?
The BiCNS device is being tested for safety and effectiveness in people with quadriplegia. It includes various components like electrode arrays, signal processors, and stimulators aimed at restoring some neurological functions.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include risks associated with surgical implantation of devices such as infection, bleeding, pain at the implant site, possible interference with brain function, and reactions to materials.

BiCNS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been cleared for surgery by my healthcare team.
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I only have a spinal cord injury, with no other neurological or orthopedic conditions.
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My spinal cord injury is severe but I can move some leg muscles.
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I am willing and able to give my consent for treatment.
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I can travel up to 50 miles three times a week for the study.
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I agree to participate in the study and still want to at the start of it.
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I have tetraplegia between C4-C6 without neurodegenerative disease or active cancer.

BiCNS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of BiCNS: The device is not explanted during 52-week study
Secondary outcome measures
Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS
Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).

BiCNS Trial Design

1Treatment groups
Experimental Treatment
Group I: Surgical implantation of BiCNSExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,765 Total Patients Enrolled
2 Trials studying Quadriplegia
100 Patients Enrolled for Quadriplegia
Pablo A Celnik, MDPrincipal InvestigatorJohns Hopkins University

Media Library

BiCNS (Neuroprosthetic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03161067 — N/A
Quadriplegia Research Study Groups: Surgical implantation of BiCNS
Quadriplegia Clinical Trial 2023: BiCNS Highlights & Side Effects. Trial Name: NCT03161067 — N/A
BiCNS (Neuroprosthetic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03161067 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
Recent research and studies
~1 spots leftby Jul 2025