RecruitingTetraplegiaLocked-in SyndromeBrainstem Stroke
Investigation on the Cortical Communication (CortiCom) System
Eligible age
22–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Johns Hopkins University
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Maryland
Baltimore
Source: ClinicalTrials.gov · NCT03567213 · last updated 2026-08-21