Investigation on the Cortical Communication (CortiCom) System

Study Purpose:

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Device

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT03567213

Neals Affiliated?

No

Coordinating Center Contact Information


Emily Caporello Bluvas, Ph.D. / .(JavaScript must be enabled to view this email address) / 301-679-0969
.(JavaScript must be enabled to view this email address)

Full Study Summary:

The successful adoption of brain-computer interfaces (BCIs) as assistive technologies (ATs) for disabled populations depends on the ability to elicit rapid, intuitive, and reliable control signals. To date, it is not known which sources of neural information provide the most natural and efficient means of control. This study will directly assess the efficacy of two sources of neural control signals, speech and motor cortex, for BCI control of software and devices using investigators' Cortical Communication (CortiCom) system.

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.

Investigators' study will be the first to investigate the efficiency and intuitiveness of two contrasting neural control strategies for BCI: Motor imagery and speech. As the first study to chronically and simultaneously record from human speech and motor regions, this study seeks to achieve the following:

  • demonstrate the ability to decode intended upper extremity movements using information decoded from primary motor cortex arm/hand area;
  • demonstrate the ability to decode intended speech from articulatory speech cortex; and
  • determine the most effective and intuitive user strategies (e.g. imagined speech or imagined movement) and optimal neural sources for brain-computer interactions,

The patient populations targeted in this study are amyotrophic lateral sclerosis (ALS), brainstem stroke, locked-in syndrome (LIS), and tetraplegia. Individuals within these populations may have normal cortical function and cognition while suffering from motor or combined speech and motor deficits.

Based on research by colleagues, as well as investigators' own experience working with participants affected by epilepsy implanted with high density electrocorticographic grids, investigators hypothesize that long-term recording of neural activity from the targeted cortical areas may provide a new communication channel for these clinical populations. The utilization of high-channel-count (up to 128 channel) ECoG grids, in combination with simultaneous coverage of speech and motor cortex, will enable investigations into the performance of speech-mediated and motor-mediated control efficacy as applied to a variety of end effectors, such as computers, tablets, headsets for virtual or augmented reality, smart lights, televisions, and assistive technologies. Additionally, eye-tracking may be utilized in combination with neural commands to improve target selection performance and ease.

Through this study, investigators will assess the performance of speech- and motor-mediated control using chronic, high-channel count ECoG grid neural implants in pursuit of a high-performing, clinically beneficial BCI assistive technology.

Study Sponsor:

Johns Hopkins University

Participant Duration:

Estimated Enrollment:

5

Estimated Study Start Date:

12/31/2018

Estimated Study Completion Date:

06/30/2019

Posting Last Modified Date:

01/30/2019

Date Study Added to alsconsortium.org:

10/19/2018
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    22

    Maximum Age:

    70

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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

  • Site Contact Information

    Johns Hopkins Medicine
    Nathan E. Crone, MD / .(JavaScript must be enabled to view this email address) / 410-955-6772
    Baltimore, Maryland 21205
    United States