- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03161067
Investigation on the Bidirectional Cortical Neuroprosthetic System (BiCNS)
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pablo A Celnik, MD
- Phone Number: 4105022446
- Email: pcelnik@jhmi.edu
Study Contact Backup
- Name: Manuel Anaya, MD
- Email: manaya1@jhmi.edu
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Department of Physical Medicine and Rehabilitation
-
Contact:
- Pablo Celnik, MD
- Phone Number: 410-502-2420
- Email: pcelnik@jhmi.edu
-
Contact:
- Manuel Anaya
- Email: manaya@jhmi.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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 Criteria:
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
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surgical implantation of BiCNS
|
Surgical implantation
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy of BiCNS: Control of one end-effector using neural signals acquired by the BiCNS
Time Frame: 52 weeks
|
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: 3) Performs test normally 2) Completes test, but takes abnormally long or has great difficulty 1) Performs test partially 0) Can perform no part of test |
52 weeks
|
Sensory feedback: the participants can perceive environmental information through delivery of intracortical microstimulation (ICMS).
Time Frame: 52 weeks
|
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).
|
52 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pablo A Celnik, MD, Johns Hopkins University
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00106844
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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