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Investigating the BiCNS System for Tetraplegia

This study is looking into a device called the Bidirectional Cortical Neuroprosthetic System (BiCNS) for people with tetraplegia (quadriplegia). The BiCNS involves surgically implanting small electrode arrays into the brain. These arrays can both record brain signals to control other devices and send information back to the brain. The main goal of this early study is to check the safety of the BiCNS device over 52 weeks. You might be able to join if you are between 22 and 65 years old and have C4-C6 tetraplegia from causes other than neurodegenerative diseases or active cancer. The study is currently unclear on its recruitment status and plans to enroll 5 participants.

Study design
This is an early feasibility study, meaning it's one of the first times this device is being tested in people. It plans to enroll 5 participants.
What's involved
The main procedure involves surgical implantation of the BiCNS device. The study will then monitor the device's safety for 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 52 weeks to assess the safety of the device.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03161067

Investigation on the Bidirectional Cortical Neuroprosthetic System

Recruiting
NAAges 22–65InterventionalDevice feasibility
Johns Hopkins University
~5 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BiCNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of BiCNS: The device is not explanted during 52-week study
Measured over 52 weeks

Conditions

Tetraplegia
Quadriplegia

Explore related trials

QuadriplegiaSpinal Cord Injury

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Nathan E Crone, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Nathan E Crone, MD
[email protected]
4109559441
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Safety of BiCNS: The device is not explanted during 52-week study52 weeks

    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.