RECRUITING

Investigation on the Bidirectional Cortical Neuroprosthetic System

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigation on the Bidirectional Cortical Neuroprosthetic System

Quick Facts

Study Start:2017-08-01

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03161067

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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).

Inclusion Criteria

Exclusion Criteria

* 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

* 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).

Contacts and Locations

Study Contact

Nathan E Crone, MD

CONTACT

4109559441

ncrone@jhmi.edu

Francesco Tenore, PhD

CONTACT

4437789774

francesco.tenore@jhuapl.edu

Principal Investigator

Nathan E Crone, MD

PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Study Locations (Sites)

Department of Neurology

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Nathan E Crone, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-01

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2017-08-01

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Tetraplegia
Quadriplegia