[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100329283":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":30,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgical implantation of the CortiCom system","EXPERIMENTAL",null,[13],"Device: Surgical implantation of CortiCom system",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DEVICE","Surgical implantation of CortiCom system","Implantation of Cortical communication system, consisting of one or two Electrocorticography (ECoG) grids connected to a transcutaneous patient pedestal.",[9],[21],{"name":22,"affiliation":23,"role":24},"Nathan E Crone, MD","Professor of Neurology","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},"CONTACT","410-955-6772","ncrone@jhmi.edu",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Johns Hopkins Medicine","RECRUITING","Baltimore","Maryland","21205","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-76.61219,39.29038,{"lat":43,"lon":42},[46,47],{"name":22,"role":27,"phone":28,"phoneExt":11,"email":29},{"name":22,"role":24,"phone":11,"phoneExt":11,"email":11},{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51],{"name":52,"class":53},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100329283","investigation-on-the-cortical-communication-corticom-system-100329283",false,"NCT03567213","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* Clinical diagnosis of tetraplegia (quadriplegia), brainstem stroke , amyotrophic lateral sclerosis (ALS) or Locked-in Syndrome (LIS)\n* Tetraplegia diagnosis, ALS diagnosis, stroke, or LIS etiology onset occurred at least one year prior to enrollment\n* 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.\n* 22-70 years\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* 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\n* Ability and willingness to travel up to 100 miles to study location up to three days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Participant consents to the study and still wishes to participate at the time of the study\n\nExclusion Criteria:\n\n* 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.\n* Suicide attempt or persistent suicidal ideation within the past 12 months.\n* 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.\n* History of substance abuse, narcotic dependence, or alcohol dependence in past 24 months\n* Medical conditions contraindicating surgery of a chronically implanted device (e.g. osteomyelitis, diabetes, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, blood or cardiac disorder requiring chronic anti-coagulation)\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations within desired risk levels too challenging (to be decided by neurological and neurosurgical team)\n* Prior cranioplasty\n* Inability to undergo MRI or anticipated need for an MRI during the study period\n* Participants with active infections or unexplained fever\n* 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\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control\n* Corrected vision poorer than 20\u002F100\n* HIV or AIDS infection\n* Existing scalp lesions or skin breakdown\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or requires chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Participants in whom it is medically contraindicated to stop anti-coagulant medications during surgery","ALL","22 Years","70 Years",{"count":65,"type":66},3,"ESTIMATED","INTERVENTIONAL",[69],"NA","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.",[72,73,74,75],"Tetraplegia","Locked-in Syndrome","Brainstem Stroke","Amyotrophic Lateral Sclerosis",[72,77,73,78,79,80,81,82],"ALS","Brainstem stroke","Brain Computer Interface","Rehabilitation","Stroke","Hopkins","2025-07-22",{"date":85,"type":86},"2025-07-25","ACTUAL",{"date":88,"type":86},"2021-12-14",{"date":90,"type":66},"2026-08-31",{"name":5,"class":6},1]