Actively Recruiting
Investigation on the Cortical Communication (CortiCom) System
Led by Johns Hopkins University · Updated on 2025-07-25
3
Participants Needed
1
Research Sites
245 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigation on the Cortical Communication (CortiCom) System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke, amyotrophic lateral sclerosis (ALS), or locked-in syndrome (LIS)
- Diagnosis of tetraplegia, ALS, stroke, or LIS at least one year prior to enrollment
- Complete or incomplete tetraplegia, tetraparesis, or severe ataxia, possibly combined with severe motor-related speech impairment
- Age between 22 and 70 years
- Meets surgical safety criteria with clearance from healthcare providers and consultants
- Ability to communicate reliably, such as through eye movement
- Willingness and ability to provide informed consent
- 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
- Ability to understand and comply with study session instructions
- Consent to participate and willingness to continue at the time of study
You will not qualify if you...
- Significant psychiatric conditions or cognitive impairments interfering with consent or participation
- Suicide attempt or persistent suicidal thoughts within the past 12 months
- Implanted devices incompatible with MRI such as pacemakers or deep brain stimulators
- History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months
- Medical conditions contraindicating surgery (e.g., osteomyelitis, diabetes, hepatitis, autoimmune diseases, epilepsy, skin disorders, blood or cardiac disorders requiring chronic anticoagulation)
- Other chronic unstable medical conditions interfering with participation
- Presurgical neuroimaging findings that prevent safe implant placement
- Prior cranioplasty
- Inability to undergo MRI or need for MRI during study
- Active infections or unexplained fever
- Significant pulmonary, cardiovascular, metabolic, or renal impairments making surgery unsafe
- Pregnancy or nursing, planning pregnancy, or lack of adequate birth control
- Corrected vision poorer than 20/100
- HIV or AIDS infection
- Existing scalp lesions or skin breakdown
- Chronic oral or intravenous steroid or immunosuppressive use
- Active cancer within past year or requiring chemotherapy
- Uncontrolled autonomic dysreflexia within past 3 months
- Hydrocephalus with or without ventricular shunt
- Medical contraindications to stopping anticoagulant medications during surgery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21205
Actively Recruiting
Research Team
N
Nathan E Crone, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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