[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523324":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":53,"collaborators":57,"id":61,"slug":18,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":18,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BrainGate Neural Interface System","EXPERIMENTAL","Placement of the BrainGate2 sensor(s) into the speech-related cortex",[13],"Device: BrainGate Neural Interface System",[15],{"type":16,"name":9,"description":11,"armGroupLabels":17,"otherNames":18},"DEVICE",[9],null,[20],{"name":21,"affiliation":22,"role":23},"Sergey Stavisky, Ph.D.","University of California, Davis","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Leigh R. Hochberg, M.D., Ph.D.","CONTACT","617-724-9247","lhochberg@mgh.harvard.edu",{"name":21,"role":27,"phone":31,"phoneExt":18,"email":32},"530-754-3413","sstavisky@ucdavis.edu",[34],{"facility":22,"status":35,"city":36,"state":37,"zip":38,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Sacramento","California","95817","United States",{"type":41,"coordinates":42},"Point",[43,44],-121.4944,38.58157,{"lat":44,"lon":43},[47,51],{"name":48,"role":27,"phone":49,"phoneExt":18,"email":50},"David M Brandman, M.D.","916-703-5010","dmbrandman@ucdavis.edu",{"name":52,"role":27,"phone":31,"phoneExt":18,"email":32},"Sergey Stavisky, Ph.D",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Leigh R. Hochberg, MD, PhD.","Neurologist",[58],{"name":59,"class":60},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100523324",false,"NCT06094205","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)","Understanding and Restoring Speech Production Using an Intracortical Brain-computer Interface","BG-Speech-02","Inclusion Criteria:\n\n* Between 18 and 80 years of age\n* Clinical diagnosis of spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis or other motor neuron disorders\n* Complete or incomplete tetraplegia (quadriplegia)\n* Must live within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.\n\n(There are additional inclusion criteria)\n\nExclusion Criteria:\n\n* Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses\n* Chronic oral or intravenous steroids or immunosuppressive therapy\n* Other serious disease or disorder that could seriously affect ability to participate in the study\n\n(There are additional exclusion criteria)","ALL","18 Years","80 Years",{"count":72,"type":73},2,"ESTIMATED","INTERVENTIONAL",[76],"NA","The goal of this study is to improve our understanding of speech production, and to translate this into medical devices called intracortical brain-computer interfaces (iBCIs) that will enable people who have lost the ability to speak fluently to communicate via a computer just by trying to speak.",[79,80,81,82,83,84,85,86],"Anarthria","Dysarthria","Tetraplegia","Spinal Cord Injuries","Amyotrophic Lateral Sclerosis","Brain Stem Infarctions","Locked-in Syndrome","Muscular Dystrophies","2025-11-26",{"date":89,"type":90},"2025-12-01","ACTUAL",{"date":92,"type":90},"2023-10-16",{"date":94,"type":73},"2027-08-31",{"name":55,"class":6},1]