Recruiting

CortiCom

Sponsor:

Johns Hopkins University

Code:

NCT03567213

Conditions

Tetraplegia

Locked-in Syndrome

Brainstem Stroke

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

Interventions

Surgical implantation of CortiCom system

Study Details

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.

Conditions

Tetraplegia

Locked-in Syndrome

Brainstem Stroke

Amyotrophic Lateral Sclerosis

Study ID

NCT03567213

Start date

Dec 14, 2021

Status verified date

Aug, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Surgical implantation of the CortiCom system

Interventions

Surgical implantation of CortiCom system

Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.

Primary outcome measure

  • Time to device explantation [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Nathan E Crone, MD

410-955-6772ncrone@jhmi.edu

Locations

Johns Hopkins Medicine

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Nathan E Crone, MD

410-955-6772ncrone@jhmi.edu

Principal Investigator:

Nathan E Crone, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • Tetraplegia
  • ALS
  • Locked-in Syndrome
  • Brainstem stroke
  • Brain Computer Interface
  • Rehabilitation
  • Stroke
  • Hopkins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-08-21.