[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653891":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":25,"studyPopulation":18,"armGroups":26,"interventions":33,"overallOfficials":46,"centralContacts":50,"locations":18,"responsibleParty":59,"collaborators":18,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":18,"studyType":76,"phases":77,"briefSummary":78,"conditions":79,"keywords":84,"overallStatus":90,"whyStopped":18,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":18},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Safety of the BrainGate2 Neural Interface System","The primary endpoint of this Study is to determine the safety of the BrainGate2 Neural Interface System","One year post-implant evaluation period",[14],{"measure":15,"description":16,"timeFrame":17},"Feasibility of speech decoding","The secondary endpoints of this Study are to investigate the feasibility of the BrainGate system and to establish the parameters for a larger clinical study, The main secondary endpoint is the ability of the system to decode neural signals related to speech \u002F language generation into output for text- and\u002For speech- generating devices.","One-year post implant evaluation period",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE","The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment or aphasia, to recover a host of abilities that normally rely on the hands or on speech.",[27],{"label":28,"type":29,"description":30,"interventionNames":31},"BrainGate Neural Interface System","EXPERIMENTAL","Device: Placement of the BrainGate2 sensor(s) into the motor-related cortex. Up to six 4x4 mm NeuroPort or MultiPort sensor(s) are placed into the speech or language areas of cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.",[32],"Device: BrainGate Neural Interface System",[34],{"type":35,"name":28,"description":36,"armGroupLabels":37,"otherNames":38},"DEVICE","Up to six 4x4 mm BrainGate sensor(s) are placed into the speech or language-related cortex, connected to one, two, or three percutaneous pedestals. Neural recordings are made at least weekly for a year or more.",[28],[39,40,41,42,43,44,45],"BrainGate","NeuroPort","neural prosthesis","neural prosthetic","neuroprosthetic","brain computer interface","brain-computer interface",[47],{"name":48,"affiliation":5,"role":49},"Leigh R Hochberg, MD, PhD","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":18,"email":55},"Leigh R Hochberg, M.D., Ph.D.","CONTACT","617-726-9247","clinicaltrials@braingate.org",{"name":57,"role":53,"phone":58,"phoneExt":18,"email":55},"Maryam Masood, M.S.","617-726-2241",{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"SPONSOR_INVESTIGATOR","Leigh R. Hochberg, MD, PhD.","Sponsor-Investigator","100653891","braingate2-feasibility-study-of-an-intracortical-neural-interface-system-for-persons-with-aphasia-100653891",false,"NCT07791459","BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia","BG2-Aphasia","Inclusion Criteria:\n\n* Clinical diagnosis of expressive aphasia due to ischemic or hemorrhagic stroke (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 (There are additional exclusion criteria)","ALL","18 Years","80 Years",{"count":74,"type":75},5,"ESTIMATED","INTERVENTIONAL",[20],"The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with aphasia to generate text on a computer screen and audible, computer-generated speech by attempting to speak.",[80,81,82,83],"Expressive Aphasia","Aphasia Following Cerebral Infarction","Aphasia Following Nontraumatic Intracerebral Hemorrhage","Aphasia Non Fluent",[85,86,87,88,39,43,89],"Brain-Computer Interface","BCI","Aphasia","Brain-Machine Interface","Neuroport","NOT_YET_RECRUITING","2026-08-27",{"date":93,"type":94},"2026-08-31","ACTUAL",{"date":96,"type":75},"2026-08",{"date":98,"type":75},"2038-12",{"name":61,"class":6}]