TetraplegiaBiCNSNCT03161067
Investigation on the Bidirectional Cortical Neuroprosthetic System
A study testing BiCNS in people with Tetraplegia and Quadriplegia, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Tetraplegia, Quadriplegia
- What is being tested?
- BiCNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria 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 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
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- 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
Who cannot join
- 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 following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:
- 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
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Department of Neurology
Baltimore, Maryland, 21287
Nathan E Crone, MD, 410-955-9441, ncrone@jhmi.edu
About this study
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.
Read the detailed description
This proposed early feasibility, investigator-initiated study is led by Dr. Nathan E. Crone, M.D. at Johns Hopkins Medicine (JHM). The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of modified versions of 510(k) cleared NeuroPort Electrode Array Systems (Blackrock Microsystems, Inc., Salt Lake City, UT) as well as a neurostimulator module (CereStim R96) for long term neural recording and intracortical microstimulation (ICMS) of the brain. The BiCNS is termed bidirectional because it permits both the recording of information from the brain for controlling an end effector device, as well as enabling information regarding that end effector to be returned to the brain in the form of ICMS. "End effector" in this sense is used to mean a physical or virtual device designed to interact with its (physical or virtual) environment. Electrode arrays will be implanted in the brain in pairs, with a pair comprising a recording array and a stimulating array. A total of six NeuroPort arrays, consisting of three array pairs, will be implanted in each study participant. Each pair will consist of an array implanted in primary motor cortex (M1) for recording and an array implanted in primary sensory cortex (S1) for stimulation and/or recording; both arrays in each pair will be connected to a single percutaneous pedestal as an external interface. In each participant, two such array pairs will be implanted in the hand/arm area of M1 and S1 in the dominant brain hemisphere (e.g., the left hemisphere for a right-handed individual). A third pair will be implanted in the hand/arm area of M1 and S1 in non-dominant hemisphere (e.g. right hemisphere for a right handed-individual). The recording arrays implanted in M1 are the NeuroPort microelectrode arrays with platinum (Pt) tips (K070272), whereas the ICMS arrays implanted in S1 are NeuroPort microelectrode arrays with Sputtered Iridium-Oxide Film (SIROF) tips (K110010). The study has Investigational Device Exemption (IDE) approval from FDA to implant these devices for 52 weeks (plus/minus 2 weeks).
- Conditions
- Tetraplegia, Quadriplegia
- Being tested
- BiCNS
- Keywords
- Tetraplegia, Rehabilitation, Brain Computer Interface, Intracortical Microstimulation, Upper extremity prosthetics, Cervical spinal cord injury, Bilateral, Quadriplegia
- Medical subject headings
- Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiCNSDevice
Also called NeuroPort
Surgical implantation
| Study group | Role | What they receive |
|---|---|---|
| Surgical implantation of BiCNS | Experimental | Not described Receives: Device: BiCNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of BiCNS: The device is not explanted during 52-week study
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.
Measured: 52 weeks
Secondary outcomes (2)
Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS
One or more participants demonstrate successful control of an assistive device using the action research arm test (ARAT). The ARAT's is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from:
- Performs test normally 2) Completes test, but takes abnormally long or has great difficulty
- Performs test partially 0) Can perform no part of test
Measured: 52 weeks
Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).
Intracortical microstimulation will be delivered to participants through the BiCNS device. The effect of ICMS will be measured based on participants' verbal reporting of what the stimuli feel like (quality of percepts) and where they appear to be coming from (location of percepts).
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start1 Aug 2017
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathan E Crone, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161067
- Sponsor's protocol ID
- IRB00106844
- Acronym
- BiCNS
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2017
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Nickl RW, Anaya MA, Thomas TM, Fifer MS, Candrea DN, McMullen DP, Thompson MC, Osborn LE, Anderson WS, Wester BA, Tenore FV, Crone NE, Cantarero GL, Celnik PA. Characteristics and stability of sensorimotor activity driven by isolated-muscle group activation in a human with tetraplegia. Sci Rep. 2022 Jun 20;12(1):10353. doi: 10.1038/s41598-022-13436-2.
PubMed 35725741Fifer MS, McMullen DP, Osborn LE, Thomas TM, Christie B, Nickl RW, Candrea DN, Pohlmeyer EA, Thompson MC, Anaya MA, Schellekens W, Ramsey NF, Bensmaia SJ, Anderson WS, Wester BA, Crone NE, Celnik PA, Cantarero GL, Tenore FV. Intracortical Somatosensory Stimulation to Elicit Fingertip Sensations in an Individual With Spinal Cord Injury. Neurology. 2022 Feb 15;98(7):e679-e687. doi: 10.1212/WNL.0000000000013173. Epub 2021 Dec 8.
PubMed 34880087
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Bidirectional Cortical Neuroprosthetic System
- ClinicalTrials.gov ID
- NCT03161067
- Acronym / sponsor ID
- BiCNS / IRB00106844
- Conditions
- Tetraplegia, Quadriplegia
- Keywords
- Tetraplegia, Rehabilitation, Brain Computer Interface, Intracortical Microstimulation, Upper extremity prosthetics, Cervical spinal cord injury, Bilateral, Quadriplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This proposed early feasibility, investigator-initiated study is led by Dr. Nathan E. Crone, M.D. at Johns Hopkins Medicine (JHM). The Bidirectional Cortical Neuroprosthetic System (BiCNS) consists of modified versions of 510(k) cleared NeuroPort Electrode Array Systems (Blackrock Microsystems, Inc., Salt Lake City, UT) as well as a neurostimulator module (CereStim R96) for long term neural recording and intracortical microstimulation (ICMS) of the brain. The BiCNS is termed bidirectional because it permits both the recording of information from the brain for controlling an end effector device, as well as enabling information regarding that end effector to be returned to the brain in the form of ICMS. "End effector" in this sense is used to mean a physical or virtual device designed to interact with its (physical or virtual) environment. Electrode arrays will be implanted in the brain in pairs, with a pair comprising a recording array and a stimulating array. A total of six NeuroPort arrays, consisting of three array pairs, will be implanted in each study participant. Each pair will consist of an array implanted in primary motor cortex (M1) for recording and an array implanted in primary sensory cortex (S1) for stimulation and/or recording; both arrays in each pair will be connected to a single percutaneous pedestal as an external interface. In each participant, two such array pairs will be implanted in the hand/arm area of M1 and S1 in the dominant brain hemisphere (e.g., the left hemisphere for a right-handed individual). A third pair will be implanted in the hand/arm area of M1 and S1 in non-dominant hemisphere (e.g. right hemisphere for a right handed-individual). The recording arrays implanted in M1 are the NeuroPort microelectrode arrays with platinum (Pt) tips (K070272), whereas the ICMS arrays implanted in S1 are NeuroPort microelectrode arrays with Sputtered Iridium-Oxide Film (SIROF) tips (K110010). The study has Investigational Device Exemption (IDE) approval from FDA to implant these devices for 52 weeks (plus/minus 2 weeks).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical implantation of BiCNS | Experimental | Device: BiCNS |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants must meet all inclusion criteria, verified by medical evaluation, psychological evaluation, and review of medical history. Inclusion criteria 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 be contracted
- Injury more than one year prior to enrollment
- Participant has a life expectancy of greater than 5 years
Key exclusion criteria (27 listed)
- 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 following criteria will exclude participants from eligibility to participate. In addition, the medical team has the right to withdraw the participant at any time if any of the exclusion criteria emerge and participants can withdraw at any time for any reason. Withdrawal details are outlined below exclusion criteria. Exclusion criteria include:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiCNSAlso: NeuroPortSurgical implantation | Device | Surgical implantation of BiCNS |
Primary outcome
Safety of BiCNS: The device is not explanted during 52-week study
Time frame: 52 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.
2 secondary outcomes
Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS
Time frame: 52 weeks
Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 35725741Nickl RW, Anaya MA, Thomas TM, Fifer MS, Candrea DN, McMullen DP, Thompson MC, Osborn LE, Anderson WS, Wester BA, Tenore FV, Crone NE, Cantarero GL, Celnik PA. Characteristics and stability of sensorimotor activity driven by isolated-muscle group activation in a human with tetraplegia. Sci Rep. 2022 Jun 20;12(1):10353. doi: 10.1038/s41598-022-13436-2.
- Derived from this study: PubMed 34880087Fifer MS, McMullen DP, Osborn LE, Thomas TM, Christie B, Nickl RW, Candrea DN, Pohlmeyer EA, Thompson MC, Anaya MA, Schellekens W, Ramsey NF, Bensmaia SJ, Anderson WS, Wester BA, Crone NE, Celnik PA, Cantarero GL, Tenore FV. Intracortical Somatosensory Stimulation to Elicit Fingertip Sensations in an Individual With Spinal Cord Injury. Neurology. 2022 Feb 15;98(7):e679-e687. doi: 10.1212/WNL.0000000000013173. Epub 2021 Dec 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan E Crone, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BiCNS in people with Tetraplegia and Quadriplegia, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan E Crone, MD (4109559441, ncrone@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of BiCNS: The device is not explanted during 52-week study (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161067, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.