RECRUITING

Investigation on the Cortical Communication (CortiCom) System

Conditions

Tetraplegia Locked-in Syndrome Brainstem Stroke Amyotrophic Lateral Sclerosis ALS Brain Computer Interface Rehabilitation Stroke Hopkins

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Investigation on the Cortical Communication (CortiCom) System

Quick Facts

Study Start:2021-12-14

Study Completion:2026-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03567213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Nathan E Crone, MD

CONTACT

410-955-6772

ncrone@jhmi.edu

Principal Investigator

Nathan E Crone, MD

PRINCIPAL_INVESTIGATOR

Professor of Neurology

Study Locations (Sites)

Johns Hopkins Medicine

Baltimore, Maryland, 21205

United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

Nathan E Crone, MD, PRINCIPAL_INVESTIGATOR, Professor of Neurology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14

Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-12-14

Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Tetraplegia
Locked-in Syndrome
Brainstem Stroke
Amyotrophic Lateral Sclerosis