Back to search results

CortiCom System for Communication in Tetraplegia and Related Conditions

This study is investigating a new system called CortiCom to help people with conditions like tetraplegia (paralysis affecting all four limbs), locked-in syndrome, brainstem stroke, or amyotrophic lateral sclerosis (ALS) communicate. The CortiCom system involves surgically implanting one or two small grids (Electrocorticography or ECoG grids) onto the brain. These grids are connected to a small device on the skin. Researchers want to see how well people can control software and devices using signals from areas of the brain that control speech and movement. The main goal is to see how long the implanted device stays in place, measured at 26 weeks. You might be able to join if you are between 22 and 70 years old and have one of these conditions for at least a year.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 3 participants.
What's involved
The study involves the surgical implantation of the CortiCom system, which includes one or two ECoG grids, for six months. The primary endpoint is measured at 26 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, time to device explantation, is measured at 26 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03567213

Investigation on the Cortical Communication (CortiCom) System

Recruiting
NAAges 22–70InterventionalDevice feasibility
Johns Hopkins University
~3 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Surgical implantation of CortiCom system

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to device explantation
Measured over 26 weeks

Conditions

Tetraplegia
Locked-in Syndrome
Brainstem Stroke
Amyotrophic Lateral Sclerosis

Explore related trials

Amyotrophic Lateral SclerosisBrain stem infarctionLocked-In StateQuadriplegia

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Nathan E Crone, MD · PRINCIPAL_INVESTIGATOR · Professor of Neurology

Who to contact

Nathan E Crone, MD
[email protected]
410-955-6772
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Time to device explantation26 weeks

    This study outcome will be considered successful if the device is not explanted during the 26-week period of the study. Explantation of the device prior to the completion of the 26-week period implies that the device is putting the subject at risk (e.g. through a serious infection at the implantation site) and therefore must be removed.