[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locked-in-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locked-in-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,44,75,103,139,162,184,204,232],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100054293","evaluation-of-the-feasibility-and-efficacy-of-a-chronic-brain-computer-interface-for-speech-rehabilitation-in-patients-with-locked-in-syndrome-lis-100054293",false,"NCT07698496","Evaluation of the Feasibility and Efficacy of a Chronic Brain-computer Interface for Speech Rehabilitation in Patients With Locked-in-syndrome (LIS)","SpeechBCI","Inclusion Criteria:\n\na. Male or female between 18 and 65 years old b. French speaking person c. Person in locked in syndrome with a severe speech disorder following either: i. A subcortical stroke ii. Amyotrophic Lateral Sclerosis. d. Person with stable clinical state (esp. regarding respiratory state) e. Person able to read on a screen (sufficient eye movement control) f. Negative plasma pregnancy test for women of childbearing potential\\* g. Highly effective or at least acceptable\\*\\* contraception for women of childbearing potential.\n\nh. Persistence of localizing signals of language function proven by functional MRI.\n\ni. Person able to perform a simple BCI task with MEG j. Person with a neuropsychological profile evaluated by psychiatrist as compatible with sustain BCI training k. Informed consent to participate in the obtained using their usual means and code of communication (residual vocalizations, eye-blinking code, pictograms, eye tracking, alphabet chart, etc.), in the presence of their trusted person or curator who is accustomed to communicating with them using this means.\n\nl. Person affiliated to the French social security system or beneficiary of such a system\n\nExclusion Criteria:\n\nPatients with any of the following criteria cannot be included in this investigation:\n\n1. Severe cognitive disorders assessed after a neuropsychological evaluation\n2. Deafness\n3. Continuous assisted ventilation\n4. Contraindication to intracranial surgery\n5. Contra-indication to MRI (1.5T), CT-scan or their related contrast agent injection or MEG examinations.\n6. Anatomical brain MRI showing structural abnormalities in the cortical areas of language\n7. Functional impairment of language cortical areas on MRI\n8. Auditory evoked potential showing hearing impairment\n9. Person with a skull shape incompatible with one WIMAGINE implant on each hemisphere\n10. Persons referred to in Articles L1125-7 of the Public Health Code and article 64 of MDR(corresponding to all protected persons: pregnant women, women in labor, breastfeeding mothers, minors, persons deprived of liberty by judicial or administrative decision.","ALL","18 Years","65 Years",{"count":20,"type":21},3,"ESTIMATED","INTERVENTIONAL",[24],"NA","Eighteen million people worldwide are affected by speech disorders. Locked-in syndrome (LIS) represents the most extreme form of communication disability resulting from motor impairment. In France, the Association du Locked-In Syndrome (ALIS) reports approximately 500 individuals with LIS, most of whom live at home. The quality of life of people with LIS depends strongly on their ability to communicate, and speech synthesis is the mode of communication restoration most desired by individuals with LIS. Several surveys have shown that improving communication abilities in these individuals leads to a significant improvement in their quality of life as well as that of their caregivers.\n\nNatural speech allows the production of an average of 150 words per minute. Non-invasive communication methods, whether based on residual motor function (eye-blink code) or on brain-machine or brain-computer interfaces (Brain-Computer Interface, BCI) using scalp electroencephalographic (EEG) signals, involve a high cognitive load and have low efficiency (spelling only a few letters per minute). Invasive BCIs for speech rehabilitation aim to overcome the limitations of non-invasive devices (cognitive overload and slow speech rate). The intention to act (the act of speaking) is predicted by an algorithm based on the direct decoding of neuronal activity from the sensorimotor cortex (the area where articulatory muscles are represented).\n\nTo date, studies testing speech rehabilitation BCIs in humans remain rare. A subdural electrocorticographic (ECoG) invasive BCI enabled speech decoding (words and sentences from a limited repertoire) for chronic use (2 years). Real-time control of an on-screen cursor allowing spelling of up to 90 letters per minute (equivalent to text messaging) has also been achieved using an intracortical invasive BCI (Utah Array). Very recently, up to 60 words per minute were produced using an intracortical invasive BCI (Utah Array) implanted in the ventral premotor cortex, although with a connector potentially contaminated by acoustic audio feedback. Furthermore, these devices still rely on transcutaneous connectors, which may be sources of infection and prevent routine daily-life use.\n\nIn summary, there is currently no fully implantable, wireless invasive \"speech BCI\" with real-time speech synthesis suitable for long-term home use. The present study will use an intracranial extradural invasive BCI combined with a speech synthesizer, with the aim of developing a communication tool suitable for everyday use. More specifically, the SpeechBCI protocol will propose two complementary BCI approaches in the same subject: a speech BCI (primary objective, BCI\\_PAROLE device) and a cursor BCI (secondary objective). Both BCIs will use the WIMAGINE intracranial epidural system, enabling ECoG signal acquisition with a very limited risk of infection and brain injury and providing signals that are more stable over time compared with intracortical or subdural ECoG devices that retain transcutaneous connectors. These systems will allow long-term and ecological use, as the WIMAGINE implant is wireless and offers excellent long-term signal stability. The WIMAGINE implant has already been successfully tested for controlling an exoskeleton in a tetraplegic subject (operational for over 6 years) and very recently for controlling walking in real-life conditions via a spinal cord stimulator in a paraplegic individual.\n\nThe BCI\\_PAROLE device will integrate a speech synthesizer providing real-time auditory feedback to the speaker. The BCI-CURSEUR device will allow the subject to control an on-screen cursor to access various communication functionalities (web access, emails, chats, etc.). This will provide a complementary communication solution to real-time speech production.\n\nThe hypothesis of this stydy is that the intention to speak (attempted speech) will be decoded by the BCI\\_PAROLE device in individuals with LIS because, as with limb paralysis, paralysis of articulatory and phonatory muscles does not prevent the corresponding cortical map from producing specific signals. Similarly, the BCI-CURSEUR device will decode the intention to move a cursor and perform actions on a computer screen.\n\nNeuronal electrical signals will be recorded bilaterally from the ventral motor cortex (representation of lips, cheeks, tongue, palate, and larynx-the vocal tract) and from the dorsal part of the motor cortex (larynx and hand, the latter for controlling a two-degree-of-freedom cursor), using a total of 128 electrodes (64 on each cerebral hemisphere). The implant will be optimally positioned over speech motor areas using preoperative functional imaging in order to optimize speech decoding by the BCI\\_PAROLE device.",[27,28],"Locked in Syndrome","ALS (Amyotrophic Lateral Sclerosis)",[30],"Locked in syndrom, Speech disorders, Brain-computer interface, BCI, speech rehabilitation","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":21},"2026-10-10",{"date":39,"type":21},"2031-09-30",{"name":41,"class":42},"University Hospital, Grenoble","OTHER",4,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100494899","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-100494899","NCT05724173","Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia","Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis","BG-Speech-01","Inclusion Criteria:\n\n* Between 18 and 80 years of age.\n* Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases.\n* Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months.\n* Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.\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)","80 Years",{"count":20,"type":21},[24],"The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.",[57,58,59,60,61,62,27,63],"Anarthria","Dysarthria","Tetraplegia","Spinal Cord Injuries","Amyotrophic Lateral Sclerosis","Brain Stem Infarctions","Muscular Dystrophies","RECRUITING","2026-05-29",{"date":67,"type":35},"2026-06-02",{"date":69,"type":35},"2023-10-18",{"date":71,"type":21},"2027-07-31",{"name":73,"class":42},"Leigh R. Hochberg, MD, PhD.",2,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":55,"conditions":85,"keywords":87,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100126292","braingate2-feasibility-study-of-an-intracortical-neural-interface-system-for-persons-with-tetraplegia-100126292","NCT00912041","BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia","BrainGate2","Inclusion Criteria:\n\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\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* (There are additional exclusion criteria)",{"count":83,"type":21},27,[24],[59,60,61,62,27,86],"Muscular Dystrophy",[88,89,90,91,92,93],"Brain computer interface","Assistive device","Environmental control","Communication device","quadriplegia","tetraplegia","2026-05-28",{"date":96,"type":35},"2026-06-01",{"date":98,"type":4},"2009-05",{"date":100,"type":21},"2038-12",{"name":73,"class":42},6,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":52,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":123,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100628315","chinese-specific-speech-imagery-coding-using-high-density-ecog-100628315","NCT07460037","Chinese-Specific Speech Imagery Coding Using High-Density ECoG","Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography","Inclusion Criteria:\n\n* Age between 20 and 80 years.\n* Ability and willingness to provide informed consent and comply with study procedures.\n* No severe preoperative emotional or consciousness disorders that would preclude participation in experimental tasks.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Patients with cerebral eloquent-area gliomas or refractory epilepsy undergoing awake craniotomy as part of standard clinical management.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Lesions involving or adjacent to eloquent brain areas including language, motor, or memory-related regions.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Mild mass effect without severe intracranial hypertension.\n* For patients undergoing intraoperative temporary high-density ECoG coverage: Preoperative language function largely preserved, with naming, reading, and language comprehension ≥80% of normal performance.\n* For patients undergoing permanent high-density ECoG implantation: Severe speech or language dysfunction caused by stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome.\n* For patients undergoing permanent high-density ECoG implantation: No substantial improvement after 3-6 months of adequate rehabilitation and disease duration \\>12 months.\n* For patients undergoing permanent high-density ECoG implantation: Structural integrity of speech imagery-related cortices (ventral central lobule, supramarginal gyrus, superior temporal gyrus, middle temporal gyrus, middle frontal gyrus, and inferior frontal gyrus).\n* For patients undergoing permanent high-density ECoG implantation: Diagnosis of severe dysarthria or severe motor aphasia, with spontaneous speech score \\\u003C5\u002F20 on the Aphasia Battery of Chinese (ABC) and auditory comprehension ≥80% of normal levels.\n\nExclusion Criteria:\n\n* Significant mass effect with severe intracranial hypertension precluding awake craniotomy or electrode implantation.\n* Severe neurological dysfunction that would prevent participation in study procedures (except for speech or language impairment in the permanent implantation cohort).\n* Contraindications to MRI scanning or awake craniotomy, including incompatible implanted medical devices, severe claustrophobia, or obstructive sleep apnea syndrome.\n* Severe psychiatric disorders or cognitive impairment preventing participation in treatment or follow-up assessments (Mini-Mental State Examination score \\\u003C24).\n* Severe systemic medical comorbidities.\n* Pregnancy or lactation.\n* Refusal or inability to provide informed consent.","20 Years",{"count":112,"type":21},50,[24],"The goal of this study is to investigate whether high-density electrocorticography (ECoG) signals recorded from the surface of the brain can be used to decode neural representations of Mandarin Chinese speech features, including lexical tone, without requiring overt speech movements. The study focuses on the development and evaluation of decoding algorithms based on neural activity recorded during clinically indicated neurosurgical procedures.\n\nThe main questions it aims to answer are:\n\nCan high-density ECoG signals be decoded to reconstruct neural representations of Mandarin Chinese speech features, particularly lexical tone?\n\nCan neural activity recorded during silent auditory speech imagery be decoded to reconstruct tone-specific speech representations without actual articulation?\n\nThe study includes two groups of adult patients with neurological conditions who require cortical electrode placement as part of clinically indicated care:\n\nA intraoperative high-density ECoG temporary coverage group, enrolling approximately 50 patients with functional-area glioma or drug-resistant epilepsy who undergo awake neurosurgery with temporary high-density ECoG coverage for clinical functional mapping.\n\nA permanent high-density ECoG implantation group, enrolling approximately 10 patients with severe speech or language impairment caused by neurological conditions such as stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome, who receive permanent high-density cortical electrode implantation for long-term monitoring.\n\nParticipants will:\n\nComplete preoperative clinical assessments as part of standard medical care, including brain imaging, language function evaluation, and routine neurological assessments\n\nUndergo clinically indicated awake neurosurgical procedures during which high-density ECoG electrodes are placed on the cortical surface for clinical functional localization\n\nPerform language-related tasks, such as listening to speech, imagining speech, and limited spoken responses, while brain electrical activity is recorded for approximately 20-30 minutes during surgery, without altering standard surgical procedures\n\nFor participants in the permanent implantation group, participate in long-term follow-up visits approximately every 2 weeks or monthly for up to 12 months after surgery, including evaluation of signal quality and research-related analysis and optimization of decoding algorithms\n\nAll surgical procedures involving temporary or permanent electrode placement are performed for clinical indications and have been approved through institutional ethical and scientific review. Participation in this study does not alter standard clinical care for the temporary recording group and does not require additional clinical procedures beyond routine treatment.\n\nThis research aims to support the long-term development of silent brain-to-speech communication technologies for individuals with severe speech or motor impairments and to improve understanding of how frontal, parietal, and temporal brain regions represent imagined speech in tonal languages such as Mandarin Chinese.",[116,58,117,118,119,120,121,122],"Aphasia","ALS","Speech and Language Disorder","Stroke","Brain Tumor Adult","Epilepsies","locked-in Syndrome",[124,125,126,127,128],"speech imagery","speech production","Chinese Mandarin","neural encoding","speech decoding","2026-03-09",{"date":131,"type":35},"2026-03-10",{"date":133,"type":21},"2026-03-15",{"date":135,"type":21},"2028-12-31",{"name":137,"class":42},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":146,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":138},"100475403","ibci-optimization-for-veterans-with-paralysis-100475403","NCT05470478","iBCI Optimization for Veterans With Paralysis","Enhancement and Optimization of a Mobile iBCI for Veterans With Paralysis","Inclusion Criteria:\n\n* Inclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041)\n* Informally, participants will be tetraplegic or anarthric with little or no functional use of the arms and legs\n\nExclusion Criteria:\n\n* Exclusion criteria are extensive and are determined by the associated BrainGate IDE(clinicaltrials.gov # NCT00912041).",{"count":74,"type":21},[24],"VA research has been advancing a high-performance brain-computer interface (BCI) to improve independence for Veterans and others living with tetraplegia or the inability to speak resulting from amyotrophic lateral sclerosis, spinal cord injury or stoke. In this project, the investigators enhance deep learning neural network decoders and multi-state gesture decoding for increased accuracy and reliability and deploy them on a battery-powered mobile BCI device for independent use of computers and touch-enabled mobile devices at home. The accuracy and usability of the mobile iBCI will be evaluated with participants already enrolled separately in the investigational clinical trial of the BrainGate neural interface.",[150,61,62,151,86],"Spinal Cord Injury","Locked-in Syndrome","2026-02-19",{"date":154,"type":35},"2026-02-23",{"date":156,"type":21},"2026-06-16",{"date":158,"type":21},"2027-06-30",{"name":160,"class":161},"VA Office of Research and Development","FED",{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":168,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":22,"phases":173,"briefSummary":174,"conditions":175,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":4},"100612747","tdcs-rtms-intervention-for-motor-function-100612747","NCT07257601","TDCS-RTMS Intervention for Motor Function","The Effect of Transcranial Direct Current Stimulation Combined With Repetitive Transcranial Magnetic Stimulation on Motor Function Rehabilitation in Patients With Locked-in Syndrome","TRIMLiS","Inclusion Criteria:\n\n* The patients were 18-70 years old, clinically diagnosed as classic or incomplete atresia syndrome, and the onset time was 6 weeks-1 year.\n* Clear consciousness, effective communication and command response through eye movement or other established methods.\n* No drugs (sodium, calcium channel blockers or sedatives) that may affect neuromuscular function or brain stimulation effect were used, or the drugs were stably stopped for more than 1 week before enrollment.\n* The patient or his legal guardian signed the informed consent form and agreed to cooperate in completing all test procedures and evaluations.\n\nExclusion Criteria:\n\n* Metal implants (such as cardiac pacemaker, intracranial metal clip, etc.), electronic equipment or other TMS contraindications.\n* Complicated with severe cognitive impairment (such as dementia) or unable to cooperate to complete the assessment scale test.\n* Have a history of severe cardiopulmonary dysfunction, mental illness and seizures.\n* There are other neurodegenerative diseases that affect the recovery of motor function (such as amyotrophic lateral sclerosis, etc.)\n* Recently (within 1 month) participated in other clinical trials related to neuromodulation therapy.","70 Years",{"count":172,"type":21},72,[24],"This study was a multicenter randomized double-blind, sham controlled trial initiated by Zhujiang Hospital of Southern Medical University. It is planned to recruit 72 eligible patients with atresia syndrome and randomly divide them into four groups according to the ratio of 1:1:1:1. Group 1 received the sequential stimulation of true tDCS and true rTMS, group 2 received the stimulation of sham tDCS and then true rTMS, group 3 received the stimulation of true tDCS and then sham rTMS, and group 4 received the simulated stimulation of sham tDCS and sham rTMS. The patients were treated for 4 weeks, 5 days a week, once a day in the bilateral M1 area, and in the morning and afternoon on the left and right sides respectively. Each tDCS and rTMS treatment lasted for 20 minutes.Various indicators were evaluated before and after the intervention, and the observation and follow-up were conducted 1, 3, and 6 months after the intervention.",[27],"2025-12-02",{"date":178,"type":35},"2025-12-10",{"date":180,"type":21},"2025-11-30",{"date":158,"type":21},{"name":183,"class":42},"Zhujiang Hospital",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":192,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":138},"100523324","feasibility-of-the-braingate2-neural-interface-system-in-persons-with-tetraplegia-bg-speech-02-100523324","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)",{"count":74,"type":21},[24],"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.",[57,58,59,60,61,62,151,63],"2025-11-26",{"date":198,"type":35},"2025-12-01",{"date":200,"type":35},"2023-10-16",{"date":202,"type":21},"2027-08-31",{"name":73,"class":42},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":170,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":138},"100532037","investigation-on-the-cortical-communication-system-100532037","NCT06207591","Investigation on the Cortical Communication System","Investigation on the Cortical Communication (CortiCom) System","CortiCom","Inclusion Criteria:\n\n* 18-70 years\n* Clinical diagnosis of locked-in state state or likelihood of soon progressing into LIS (within an estimated 2 years), caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause\n* • Current or imminent complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis)\n* • Current or imminent motor-related speech impairment (dysarthria or anarthria)\n* Either receiving tracheostomy invasive ventilation, or having a stable and adequate respiratory situation without respiratory support, allowing for safe intubation, mechanical ventilation and detubation during surgery according to the involved clinicians, and, if relevant (e.g., in case of a progressive condition), in combination with a confirmed desire to receive tracheostomy invasive ventilation when that becomes necessary\n* Meeting surgical safety criteria, including surgical clearance by the study physicians\n* Meeting (neuro)psychological evaluation criteria\n* Ability to communicate reliably, such as through eye movement\n* Willingness and ability to provide informed consent\n* Lives within reasonable distance from University Medical Center Utrecht\n* Participant consents to the study and still wishes to participate at the time of the study\n* Vision and hearing largely intact\n\nExclusion Criteria:\n\n* Performance on formal neuropsychological testing that indicates a significant current or recent psychiatric disorder, cognitive or behavioral impairment, that would interfere with obtaining informed consent or fully participating in study activities\n* Medical conditions contraindicating surgery of a chronically implanted device or that could interfere with study participation (for example active infections, unexplained fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any autoimmune disease\u002Fdisorder, epilepsy, skin disorders causing excessive skin sloughing or poor wound healing, cranioplasty, significant cardiovascular, metabolic, or renal impairments, 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 or a medical contraindication to stop anti-coagulant medications during surgery)\n* Presence of pre-surgical findings in anatomical, functional, and\u002For vascular neuroimaging that makes achieving implant locations too challenging or incompatible with desired risk levels\n* Inability to undergo MRI for pre-implantation evaluation, for example due to the presence of 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* Anticipated need for MRI after implantation of the CortiCom assembly",{"count":74,"type":21},[24],"The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.\n\nThe main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI.\n\nParticipants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 times per week for one year. Extension of participation after one year is possible.\n\nIf successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.",[151,216,217,218],"Neuromuscular Diseases","Brainstem Stroke","Traumatic Brain Injury",[220,221,222],"Locked-in","Amyotrophic lateral sclerosis","Neurodegenerative disease","2025-09-29",{"date":225,"type":35},"2025-10-03",{"date":227,"type":35},"2023-12-15",{"date":229,"type":21},"2029-09",{"name":231,"class":42},"UMC Utrecht",{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":237,"maxAge":170,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":138},"100329283","investigation-on-the-cortical-communication-corticom-system-100329283","NCT03567213","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","22 Years",{"count":20,"type":21},[24],"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.",[59,151,217,61],[59,117,151,243,244,245,119,246],"Brainstem stroke","Brain Computer Interface","Rehabilitation","Hopkins","2025-07-22",{"date":249,"type":35},"2025-07-25",{"date":251,"type":35},"2021-12-14",{"date":253,"type":21},"2026-08-31",{"name":255,"class":42},"Johns Hopkins University"]