NCT03567213 Investigation on the Cortical Communication (CortiCom) System
| NCT ID | NCT03567213 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Tetraplegia |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2021-12-14 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2021-12-14 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The CortiCom system consists of 510(k)-cleared components: platinum PMT subdural cortical electrode grids, a Blackrock Microsystems patient pedestal, and an external NeuroPort Neural Signal Processor. Up to two grids will be implanted in the brain, for a total channel count of up to 128 channels, for six months. In each participant, the grid(s) will be implanted over areas of cortex that encode speech and upper extremity movement.
Eligibility Criteria
Inclusion Criteria: * Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS) * Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment * Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), or severe ataxia. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in LIS. * 22-70 years * Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants * Ability to communicate reliably, such as through eye movement * 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 up to 100 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 * Participant consents to the study and still wishes to participate at the time of the study Exclusion Criteria: * Performance on formal neuropsychological testing that indicates significant psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities. * Suicide attempt or persistent suicidal ideation within the past 12 months. * Implanted devices that are incompatible with MRI, which may include pacemakers, cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain stimulators, and cochlear implants. * History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months * 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 interfere with subject participation. * 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, metabolic, 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 poorer than 20/100 * 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 * Hydrocephalus with or without an implanted ventricular shunt * Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery
Contact & Investigator
Nathan E Crone, MD
PRINCIPAL INVESTIGATOR
Professor of Neurology
Frequently Asked Questions
Who can join the NCT03567213 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 70 Years, studying Tetraplegia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03567213 currently recruiting?
Yes, NCT03567213 is actively recruiting participants. Contact the research team at ncrone@jhmi.edu for enrollment information.
Where is the NCT03567213 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT03567213 clinical trial?
NCT03567213 is sponsored by Johns Hopkins University. The principal investigator is Nathan E Crone, MD at Professor of Neurology. The trial plans to enroll 3 participants.