[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsies":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100628315","chinese-specific-speech-imagery-coding-using-high-density-ecog-100628315",false,"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.","ALL","20 Years","80 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34],"Aphasia","Dysarthria","ALS","Speech and Language Disorder","Stroke","Brain Tumor Adult","Epilepsies","locked-in Syndrome",[36,37,38,39,40],"speech imagery","speech production","Chinese Mandarin","neural encoding","speech decoding","RECRUITING","2026-03-09",{"date":44,"type":45},"2026-03-10","ACTUAL",{"date":47,"type":21},"2026-03-15",{"date":49,"type":21},"2028-12-31",{"name":51,"class":52},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100581868","home-ultra-long-term-eeg-monitoring-for-rare-epilepsies-and-developmental-and-epileptic-encephalopathies-100581868","NCT06855901","Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies","Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device","EMIRE","Inclusion Criteria:\n\n* Age \\> 12 years old, with or without intellectual disabilities;\n* Diagnosis of drug resistant seizures, DEE or rare epilepsies ;\n* One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;\n* Availability for the duration of the study (3 months);\n\nExclusion Criteria:\n\n* Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;\n* Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;\n* Subject has an infection at implant site;\n* Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;\n* Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));\n* Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;\n* Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;\n* Subject is unable or does not have the necessary assistance to properly operate the device system.\n* Pregnancy","12 Years",{"count":64,"type":21},30,[24],"With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).\n\nThe following aims will be pursued:\n\n1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;\n2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure\u002Finterictal epileptic discharges; distribution for the development of personalized seizure action plan;\n3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.\n\nThe investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.\n\nThe potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.",[33,68,69],"Epilepsies, Focal","Epileptic Encephalopathy",[71,72,73,74],"Epilepsy","Epileptic encephalopathies","subscalp EEG","Ultra-long EEG monitoring","2025-02-27",{"date":77,"type":45},"2025-03-04",{"date":79,"type":45},"2024-01-17",{"date":81,"type":21},"2026-12-30",{"name":83,"class":52},"Azienda Ospedaliero-Universitaria di Modena",4]