Investigation on the Bidirectional Cortical Neuroprosthetic System

NCT03161067 | Recruiting DMC FDA Device

• 1 other identifier: IRB00106844
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. The goals of this early feasibility study consist of safety and efficacy evaluations of this device.

Conditions

Tetraplegia; Quadriplegia

Keywords

Tetraplegia; Rehabilitation; Brain Computer Interface; Intracortical Microstimulation; Upper extremity prosthetics; Cervical spinal cord injury; Bilateral; Quadriplegia

Outcome Measures

Primary Outcomes (1)

• 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.

  52 weeks

Secondary Outcomes (2)

• Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS

  52 weeks

• Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).

  52 weeks

Study Arms (1)

Surgical implantation of BiCNS

EXPERIMENTAL

Device: BiCNS

Interventions

BiCNS DEVICE

Surgical implantation

Also known as: NeuroPort

Surgical implantation of BiCNS

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Department of Neurology

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 35725741 DERIVED

• Fifer 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.

  PMID: 34880087 DERIVED

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan E Crone, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan E Crone, MD

CONTACT

4109559441; ncrone@jhmi.edu

Francesco Tenore, PhD

CONTACT

4437789774; francesco.tenore@jhuapl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: May 19, 2017
• Study Start: August 1, 2017
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)