[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disorder-of-consciousness\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disorder-of-consciousness":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,51,80,111,136,158,189,214,241,270,297,317,349,371,399,424,447,476,499,527,552,578,598],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100563531","combined-whole-brain-structural-and-functional-mri-for-the-prediction-of-neurological-recovery-after-cardiac-arrest-100563531",false,"NCT06617377","Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest","Use of Brain Structural and Functional Connectomes for the Prediction of Neurological Recovery in Coma Patients After Cardiac Arrest","ARISE","Inclusion Criteria:\n\n* Adult patients (male or female ≥ 18 years).\n* Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.\n* Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.\n* Written informed consent from patient's legal representative.\n* Affiliation or beneficiary to the French social security system.\n\nExclusion Criteria:\n\n* Brain death.\n* Coma explained by other cause than CA.\n* Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification of at least two of the following: bilaterally absent pupillary light and corneal reflexes at ≥ 72h, bilaterally absent N20 SSEP ≥ 24h; neuron-specific enolase (NSE) \\> 60 μg\u002Fl at 48h and\u002For 72h, status myoclonus ≤72h.\n* Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.\n* Life expectancy shorter than 6 months based on pre-morbid conditions.\n* Former neurological functional disability (mRS \\> 2 before CA).\n* MRI contraindication: medical material not MRI compatible, claustrophobia\n* Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium\n* Severe kidney failure defined as a KDIGO score \\> 3 (glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2 or renal replacement therapy).\n* Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.\n* Pregnancy or nursing woman.\n* Patient under juridical protection.","ALL","18 Years",{"count":20,"type":21},263,"ESTIMATED","INTERVENTIONAL",[24],"NA","To assess the performance of a predictive model resulting from the analysis of sMRI\u002FfMRI\u002Fcontrast-enhanced MRI-derived personalized connectomic data, as compared with standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict anoxoischemic coma neurological outcome at 6 months.",[27,28,29,30],"Coma","Cardiac Arrest","Disorder of Consciousness","Neurologic Disorder",[32,33,34,35,36,37],"prognosis","coma","cardiac arrest","Structural MRI","resting-state","cognitive motor dissociation","RECRUITING","2026-06-24",{"date":41,"type":42},"2026-06-29","ACTUAL",{"date":44,"type":42},"2026-03-16",{"date":46,"type":21},"2029-09",{"name":48,"class":49},"University Hospital, Toulouse","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":18,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":50},"100609061","describing-the-effect-of-familiar-song-on-arousal-and-awareness-for-children-with-disorders-of-consciousness-doc-100609061","NCT07209657","Describing the Effect of Familiar Song on Arousal and Awareness for Children With Disorders of Consciousness (DoC)","A Parallel Mixed Methods Investigation of a Music Interventions in Paediatric Disorders of Consciousness (DoC)","SongDoC","Inclusion Criteria:\n\n* Diagnosis of a severe ABI, as indicated by at least one of the following:\n\n  * Glasgow Coma Scale (GCS) 3-8 at admission to RCH\n  * Mass pathology evident on neuroimaging\n  * Expert opinion of treating consultant\n* Diagnosis of a DoC, as indicated by at least one of the following:\n\n  * Rancho Los Amigos Scale I, II, III or IV\n  * Expert opinion of treating consultant\n* Legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf. Interpreters will be employed as necessary.\n\nExclusion Criteria:\n\n* ABI not compatible with life\u002Fchild expected to die\n* ABI resulting from suspected non-accidental causes, including assault\u002Fabuse\n* Diagnosed premorbid or acquired severe hearing loss\n* Inability or unwillingness of legally acceptable representative to give written informed consent","1 Year",{"count":61,"type":21},10,[24],"The goal of this clinical trial is to compare the effect of live music therapy and recorded music on recovery of consciousness in children aged 1 to 18 years who have a disorder of consciousness (DoC) after a severe brain injury. Researchers also want to learn how children respond during music and noise, whether early responses to music are linked to recovery at 6 months, and how parents experience music therapy during their child's hospital stay at The Royal Children's Hospital (RCH) in Melbourne.\n\nParticipants will:\n\n* Take part in a 10-day study period while in hospital. On 8 of the 10 days, they will receive either live or recorded familiar music in random order. Their level of consciousness will be measured before and after each session using a simple behavioural checklist. On the other 2 days, they will take part in video-recorded sessions to compare behavioural responses during live music, recorded music, and white noise. Videos will help capture small changes in movement, eye gaze, or facial expression.\n* Have their level of consciousness checked again at 6 months after injury to see if early responses relate to later recovery.\n\nParents and caregivers will be invited to take part in an interview about their experiences and observations of music therapy with their child.\n\nThis study will help researchers understand whether live music therapy provides benefits beyond recorded music and will guide how music therapy is best used to support children and families during recovery from severe brain injury.",[29,65],"Acquired Brain Injury",[67,68,69],"music therapy","music","paediatric disorder of consciousness","NOT_YET_RECRUITING","2026-06-23",{"date":73,"type":42},"2026-06-25",{"date":75,"type":21},"2026-08",{"date":77,"type":21},"2028-11-30",{"name":79,"class":49},"Murdoch Childrens Research Institute",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":86,"enrollmentInfo":87,"targetDuration":89,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":50},"100622583","neurorehabilitation-in-patients-with-disorders-of-consciousness-multidimensional-ambispective-study-on-the-impact-of-single-and-combined-approaches-100622583","NCT07385508","Neurorehabilitation in Patients With Disorders of Consciousness: Multidimensional Ambispective Study on the Impact of Single and Combined Approaches","Inclusion Criteria:\n\n* Diagnosis of VS\u002FMCS following ABI, according to clinical and neuroradiological findings.\n* Age between 18 and 90 years.\n* Adequate pulmonary gas exchange function (PaO₂ \u002F FiO₂ ratio ≥ 250).\n* Stable haemodynamic profile (absence of significant arterial variations in mean arterial pressure and\u002For heart rate).\n\nExclusion Criteria:\n\n* Diagnosis of DOC due to non-structural aetiopathogenesis.\n* Having previously undergone multiple rehabilitation cycles\n* Being affected by deafness and\u002For blindness\n* Having unstable intracranial pressure values\n* Having cerebral perfusion values below 60 mmHg\n* Having other concomitant medical conditions that could interfere with the rehabilitation","90 Years",{"count":88,"type":21},140,"36 Months","OBSERVATIONAL","Disorders of consciousness (DOC), such as the vegetative state\u002Funresponsive wakefulness syndrome (VS\u002FUWS) and the minimally conscious state (MCS), represent severe clinical conditions arising from acquired brain injury (ABI), exerting a profound impact on patients, caregivers, and healthcare systems. The clinical heterogeneity, diagnostic challenges, and paucity of robust evidence on the comparative efficacy of rehabilitation interventions underscore the need for a deeper understanding of the underlying neurophysiological, cognitive, and biological mechanisms involved in consciousness recovery. This monocentric ambispective observational study aims to investigate the effects of advanced neurorehabilitation treatments-including multimodal sensory stimulation, non-invasive neuromodulation via transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS), and the use of augmentative and alternative communication (AAC) devices with eye-tracking-on various facets of residual consciousness in patients diagnosed with DOC admitted to the Neurorehabilitation Unit of the IRCCS Centro Neurolesi \"Bonino Pulejo\" in Messina.\n\nThe study design encompasses the collection of clinical and rehabilitation data from hospitalized patients undergoing treatment, both retrospectively and prospectively. Specifically, data from patients admitted and treated in the 36 months preceding study initiation, as well as those admitted and treated in the subsequent 36 months, will be included. Upon data collection, participants will be classified a posteriori as \"responders\" or \"non-responders\" based on whether they meet at least one of the following criteria: (I) an increase of ≥3 points on the Coma Recovery Scale-Revised (CRS-R) from baseline or a clinically relevant state transition (e.g., VS\u002FUWS → MCS; MCS → emergence from MCS \\[EMCS\\]); (II) an increase of ≥10 points on the Functional Independence Measure (FIM) or ≥0.5 standard deviations (SD) from baseline; (III) an increase of ≥10 points on the Barthel Index or ≥0.5 SD from baseline.\n\nThe primary objective is to estimate the proportion of responders and non-responders at the end of training or hospitalization. Secondary objectives include identifying variables predictive of treatment response at the end of intervention (training type\u002Fmodality, aetiology, demographic factors, comorbidities), quantifying the dose-response gradient (number of sessions\u002Fsession duration versus response probability), and assessing changes in neurophysiological, physiological, and biological parameters collected during hospitalization (neuroimaging examinations, neurofilament light chain \\[NfL\\] assays, EEG\u002Fevent-related potentials \\[ERP\\], skin conductance response, heart rate frequency and variability, and oculomotor activity).\n\nData will be analysed using descriptive statistics appropriate to variable distributions. The primary endpoint, defined as the proportion of responders at the end of training\u002Fhospitalization, will be evaluated using logistic regression models in an as-treated approach, reporting odds ratios and marginal estimates (risk ratios and absolute risk differences) with 95% confidence intervals (CI). Confounding will be addressed through multivariable adjustment and propensity score-based methods (inverse probability of treatment weighting \\[IPTW\\]\u002Foverlap weighting). Continuous secondary outcomes will be analysed with linear models or linear mixed-effects models for repeated measures. Dose-response relationships will be explored, alongside sensitivity and subgroup analyses. All analyses will be performed using R software (version 4.4.2), employing two-sided tests with a significance level of α=0.05. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines.",[29],[94,95,96,97,98,99,100,101],"Vegetative state","Minimally conscious state","Neurorehabilitation","Eye-tracking","Neurofilaments","tDCS","multimodal sensory stimulation","Skin conductance response","2026-05-25",{"date":104,"type":42},"2026-05-27",{"date":106,"type":42},"2026-01-16",{"date":108,"type":21},"2029-01-16",{"name":110,"class":49},"IRCCS Centro Neurolesi Bonino Pulejo",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":118,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":50},"100395297","phase-4-efficacy-and-safety-of-cerebrolysin-on-prolonged-disorders-of-consciousness-100395297","NCT04427241","Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness","Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness in Patients With Hemorrhagic Stroke: A Pilot Study","Inclusion Criteria\n\n1. Patients with hemorrhagic stroke confirmed by CT or MRI\n2. Patients who have been in disorders of consciousness for more than 4 weeks after the onset of hemorrhagic stroke\n3. Patients in a vegetative state or minimally conscious state (Coma Recovery Scale -revised: CRS-R assessment)\n4. Age: 19 to 80 years of age\n5. Patients who have voluntarily given written informed consent to participate in the study by themselves or their legal representative.\n\nExclusion Criteria\n\n1. Patients with confirmed epileptiform discharges on EEG\n2. Patients with brain parenchymal defects\n3. Patients with advanced liver, kidney, cardiac, or pulmonary disease.\n4. Chronic treatment with medications that may affect consciousness, such as antidepressants, antipsychotic drugs, nootropic drugs, and vasodilators.\n5. History of serious illness within the last two years (cancer, hematologic, renal, hepatic, or coronary artery disease, psychiatric illness, diabetes, myocardial infarction, epilepsy), no evidence of secondary damage to major organs, and well-controlled diabetes or hypertension.\n6. Alcohol or drug abuse or dependence within the last 2 years (DSM-V criteria).\n7. Significant systemic disease or unstable medical condition that may compromise compliance with the study protocol.\n8. Administration of a contraindicated drug is essential for medical purposes.\n9. Contraindications to the study drug (cerebrolysin).\n10. Participation in another therapeutic study","19 Years","120 Years",{"count":121,"type":21},12,[123],"PHASE4","Object: To determine the effect of cerebrolysin on prolonged disorders of consciousness caused by hemorrhagic stroke.\n\nParticipants: patients with prolonged disorders of consciousness due to severe traumatic brain injury\n\nIntervention: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once\u002Fday, intravenously or 100 ml normal saline, days 4-17, once\u002Fday, IV\n\nComparison: cerebrolysin group versus control group\n\nOutcome: Coma Recovery Scale-revised, FDG-PET signal",[29,126],"Hemorrhagic Stroke","2026-05-06",{"date":129,"type":42},"2026-05-11",{"date":131,"type":42},"2023-06-01",{"date":133,"type":21},"2026-12-31",{"name":135,"class":49},"Konkuk University Medical Center",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100635314","electroacupuncture-at-jing-well-points-for-chronic-disorders-of-consciousness-a-randomized-controlled-study-with-multimodal-assessment-100635314","NCT07551076","Electroacupuncture at Jing-Well Points for Chronic Disorders of Consciousness: A Randomized Controlled Study With Multimodal Assessment","Randomized Controlled Study of Electroacupuncture Stimulation at Jing-Well Points for Chronic Disorders of Consciousness Based on Multimodal Assessment","Inclusion Criteria:\n\n* Meet the above diagnostic criteria for pDoC and be diagnosed as Vegetative State (VS) \u002F Unresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS) based on at least two assessments using the Coma Recovery Scale-Revised (CRS-R);\n* First onset of impaired consciousness with a clear etiology (traumatic brain injury \u002F intracerebral hemorrhage \u002F cerebral infarction) and a complete medical history;\n* No obvious hydrocephalus or severe cerebral atrophy, with a disease course ranging from 28 days to 6 months;\n* Aged between 18 and 72 years, with no gender restriction;\n* No significant cognitive, hearing, or visual impairment prior to onset;\n* Able to communicate accurately in Chinese before onset, with no history of major neurological or psychiatric disorders;\n* Clinically stable and not having participated in other clinical trials within the past 3 months;\n* Informed consent signed by the patient's family member or legal representative.\n\nExclusion Criteria:\n\n* Patients with consciousness disturbance of unknown etiology;\n* Patients in coma due to neurodegenerative diseases, intracranial infection, or after brain tumor surgery;\n* Patients with severe complications;\n* Heart rate exceeding 70% of the age-predicted maximum heart rate, a decrease of \\>20% from resting heart rate, \\\u003C40 beats\u002Fmin, or \\>130 beats\u002Fmin;\n* Blood oxygen saturation \\\u003C88%; systolic blood pressure \\>180 mmHg, or presence of orthostatic hypotension, mean arterial pressure \\\u003C65 mmHg or \\>110 mmHg;\n* Patients with metallic implants such as cardiac pacemakers or spinal cord stimulators;\n* History of substance abuse prior to onset;\n* Patients with hyperalgesia in the stimulation area who are not suitable for electrostimulation at Jing-Well points;\n* Any other factors that may affect assessment and treatment;\n* Patients with uncontrolled epileptic seizures or status epilepticus;\n* Patients in whom ERP cannot be measured at the corresponding sites due to skull defects or other reasons;\n* Pregnant female patients.","72 Years",{"count":145,"type":21},66,[24],"Disorder of consciousness (DOC) is a common complication of severe central nervous system injury. It is defined as prolonged DOC when lasting more than 28 days. About 300,000-800,000 patients are affected worldwide, with an annual mortality rate of 29%-50%, causing a heavy social and family burden.\n\nAlthough progress has been made in pathophysiology, clinical outcomes remain unsatisfactory, and arousal treatment for DOC is still challenging. Internationally recommended therapies, such as neurotrophic drugs, hyperbaric oxygen and invasive neuromodulation, have side effects or uncertain efficacy.\n\nIn traditional Chinese medicine, post-TBI DOC is classified as \"shen hun\" (mental clouding). Bloodletting at Jing-Well points promotes arousal by regulating qi and blood and unblocking collaterals. Preliminary studies showed it may improve consciousness in DOC patients, but with small samples and short observation periods.\n\nAcupuncture, such as the Xingnao Kaiqiao method, induces arousal by improving cerebral blood flow and activating neural networks. Our team proposed the \"Jing-Well point-brain correlation\" hypothesis and found that electrostimulation at Jing-Well points improves cognitive function, but lacks standardized assessment and large-sample evidence.\n\nFurther research is needed to confirm its efficacy, mechanisms and suitable populations to provide high-quality evidence-based support.",[29],"2026-04-24",{"date":151,"type":42},"2026-04-30",{"date":153,"type":21},"2026-05-30",{"date":155,"type":21},"2027-03-01",{"name":157,"class":49},"The Third People's Hospital of Huizhou",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":50},"100627980","auditory-processing-in-doc-patients-100627980","NCT07455682","Auditory Processing in DOC Patients","Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration","AUD-DOC","Inclusion Criteria:\n\n* Presence of a disorder of consciousness (Unresponsive Wakefulness Syndrome \\[UWS\\] or Minimally Conscious State \\[MCS\\]), classified using the Coma Recovery Scale-Revised (CRS-R) based on three assessments conducted on at least two separate days\n* Age between 18 and 80 years\n* Written informed consent provided by the patient's legal representative\n* Preserved brainstem auditory evoked potentials (BAEPs) on at least one side\n\nExclusion Criteria:\n\n* Ongoing sedation at the time of EEG assessment\n* Current treatment with medications known to significantly affect cortical functional state, including barbiturates, neuroleptics (antipsychotics), antiepileptic drugs, benzodiazepines, or comparable agents\n* Colonization with multidrug-resistant organisms requiring isolation precautions (e.g., 4MRGN)\n* Pregnancy\n* Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)\n* Temporal bone fractures or severe infratentorial brain injury associated with unilateral or bilateral absence of auditory evoked potentials (AEPs)\n* Bilateral hearing impairment or deafness, or presence of a cochlear implant\n* Scalp wounds or conditions preventing placement of an EEG electrode cap","80 Years",{"count":168,"type":21},42,"This prospective observational study investigates whether electroencephalography (EEG) can improve the differentiation between unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) in patients with severe acquired brain injury. The study further examines the association between EEG markers of auditory processing and long-term functional outcome at 12 months.",[29,171,172],"Unresponsive Wakefulness Syndrome","Minimally Conscious State",[174,175,176,177,65,178,179],"Disorders of Consciousness","Electroencephalography (EEG)","Event-related potential (ERP)","Coma Recovery Scale-Revised (CRS-R)","Critically ill patients","Neurological rehabilitation","2026-03-03",{"date":182,"type":42},"2026-03-06",{"date":184,"type":21},"2026-04-15",{"date":186,"type":21},"2028-03-31",{"name":188,"class":49},"BDH-Klinik Hessisch Oldendorf",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":213},"100584970","study-on-the-effectiveness-and-safety-of-temporal-interference-stimulation-in-treating-patients-with-severe-consciousness-disorders-100584970","NCT06896279","Study on the Effectiveness and Safety of Temporal Interference Stimulation in Treating Patients With Severe Consciousness Disorders","Inclusion Criteria:\n\n* Severe consciousness disorder patients aged 18 to 75 years old, regardless of gender;\n* Patients with severe consciousness disorders, namely a minimally conscious state or vegetative state that lasts for 28 days or more;\n* Patients with normal body temperature, stable vital signs, spontaneous breathing, tracheotomy without the use of a metal cannula and with a small amount of sputum, and who are eligible for magnetic resonance imaging (MRI) examination;\n* Written informed consent obtained from the patient's family members in advance.\n\nExclusion Criteria:\n\n* Individuals with a previous history of significant neuropsychiatric and other major disorders such as those involving the heart, lung, liver, and kidney;\n* Those who have undergone V-P shunt or Ommaya reservoir implantation and other procedures that may influence the analysis of magnetic resonance scanning signals;\n* Patients who are scheduled for V-P shunt or Ommaya reservoir implantation in the near future;\n* Pregnant women;\n* Those who have participated in other drug or device clinical trials;\n* Patients with poorly controlled epilepsy in the recent period;\n* Those with infections at the TI stimulation site or compromised skin integrity at the electrode placement site;\n* Those currently taking medications prone to inducing epilepsy, such as quinolone drugs;\n* Those with intracranial infections, intracranial tumors, or metallic objects within the cranium;\n* Those allergic to electrode gel or adhesives;\n* Those with implanted electronic devices within the body;\n* Those with severe cardiac disorders and those equipped with cardiac pacemakers.","75 Years",{"count":197,"type":21},20,[24],"Investigating the efficacy and safety of temporal interference stimulation for patients with disorders of consciousness.",[29,201],"Temporal Interference Stimulation",[29,203,201],"Randomized clinical trail","2025-12-08",{"date":206,"type":42},"2025-12-16",{"date":208,"type":42},"2025-04-21",{"date":210,"type":21},"2026-05-17",{"name":212,"class":49},"Huashan Hospital",2,{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":195,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":227,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":240},"100552199","robotic-vs-traditional-verticalization-in-patients-with-severe-acquired-brain-injury-a-randomized-controlled-trial-100552199","NCT06469983","Robotic vs. Traditional Verticalization in Patients With Severe Acquired Brain Injury: a Randomized Controlled Trial","Multicentric Study on Combined Verticalization and Mobilization in Patients With Severe Acquired Brain Injury: A Randomized Controlled Trial","VEM-sABI","Inclusion Criteria:\n\n* Age between 18 and 75 years;\n* sABI due to traumatic, vascular, anoxic, or mixed etiology;\n* Stable behavioral\u002Fcognitive diagnosis on at least 4 behavioral evaluations in 1 week using the Italian version of the CRS-R in patients with pDoC, or the LCF-based cognitive assessment in patients with eDoC;\n* Time post-injury between 28 days and 6 months \\[1\\];\n* Not recovered upright station;\n* Written informed consent by the patient's legal rep-resentative\u002Fprimary caregiver.\n\nExclusion Criteria:\n\n* Severe medical conditions hampering verticalization (e.g., severe hypotension or conditions realizing hemodynamic instability, end stage or severe symptomatic heart failure with reduced ejection fraction, cardiac arrhythmia of new diagnosis or arrhythmic flare, severe hepatic failure, chronic severe lower limb arterio-venous disease, sep-sis\u002Fseptic shock, thrombus venous embolism of new diag-nosis, severe autonomic dysreflexia);\n* Severe medical conditions hampering lower limb mobili-zation (e.g., fractures, heterotopic ossifications);\n* Severe medical conditions impacting EEG activity (e.g., sub-continuous or abundant EEG epileptiform abnormali-ties);\n* Severe medical conditions influencing conscious-ness\u002Fcognitive status, such as severe hyponatremia or hy-poglycemia;\n* Contraindications to the use of Erigo®Basic and\u002For Eri-go®Pro (Hocoma, Volketswil, Switzerland) as per technical data sheet (see Appendix A);\n* Presence of prohibited drugs",{"count":223,"type":21},118,[24],"In the rehabilitation project for patients with severe Acquired Brain Injury (sABI), it is essential to include exercises that facilitate the recovery of the upright position (or verticalization). Recently, tilt-table equipped with the robot-assisted lower limbs cyclic mobilization has been proposed as a safe and suitable device for accelerating the adaptation to vertical posture in bedridden patients with brain-injury since the acute phase. The present multicentre study aims at evaluating the effectiveness of robotic assisted verticalization plus mobilization (VEM) versus traditional verticalization (TV) in a large cohort of patients with sABI.",[65,29],[174,228,229,230],"rehabilitation","verticalization","robotic","2025-11-17",{"date":233,"type":42},"2025-11-20",{"date":235,"type":42},"2024-12-02",{"date":237,"type":21},"2026-11-30",{"name":239,"class":49},"Anna Estraneo",6,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":255,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":50},"100609383","alpha-tacs-for-disorders-of-consciousness--a-single-case-experimental-design-100609383","NCT07213869","Alpha tACS for Disorders of Consciousness : a Single Case Experimental Design","Study of Personalized Alpha tACS for the Recovery of Disorders of Consciousness : Controlled Evaluation With a Single Case Experimental Design","SPARC","Inclusion Criteria:\n\n* Age 18 to 70 years\n* Persistent disorder of consciousness (vegetative state\u002Funresponsive wakefulness syndrome or minimally conscious state) according to the Coma Recovery Scale-Revised (CRS-R), lasting 3 to 12 months after traumatic brain injury at the time of the inclusion\n* No evidence of exit from minimally conscious state (eMCS) according to Coma Recovery Scale-Revised (CRS-R)\n\nExclusion Criteria:\n\n* Active epilepsy or major pre-existing central nervous system disorders\n\n  * Craniectomy without bone flap replacement, non-healed scalp lesions, intracerebral metallic implants (except titanium), or implanted electronic devices (e.g., pacemaker)\n  * Contraindications to MRI (non-compatible devices, metallic fragments, recent tattoos, etc.)\n  * Pregnant or breastfeeding women\n  * Persons deprived of liberty, under psychiatric care, or not affiliated with a social security\u002Fhealth insurance system","70 Years",{"count":251,"type":21},5,[24],"BRIEF SUMMARY \\* (Include a statement of the study hypothesis) Avoid all personal pronouns (Limit: 5000 characters) Disorders of consciousness (DoC) following a severe traumatic brain injury represent a major medical challenge, with very limited therapeutic options and many patients remaining in a minimally conscious state or vegetative\u002Funresponsive wakefulness state for months. To date, only two pharmacological treatments (amantadine and zolpidem) have shown partial benefits. Non-invasive neuromodulation techniques such as transcranial direct current stimulation (tDCS) have produced modest but encouraging results.\n\nRecent advances in transcranial alternating current stimulation (tACS) have demonstrated its ability to modulate brain oscillations, particularly in the alpha frequency range (8-12 Hz), which plays a central role in large-scale functional connectivity, especially within the default mode network (DMN). Neuroimaging studies suggest alpha activity and DMN connectivity are major correlate of the level of consciousness in DoC. Yet experimental evidence suggests that alpha tACS can enhance alpha power and antero-posterior connectivity in healthy subjects, as well as connectivity within the default mode network (DMN). However, no controlled study has yet evaluated its therapeutic potential in patients with DoC.\n\nThe present study (SPARC) is a single-center clinical investigation aiming to assess the clinical efficacy of alpha tACS in patients with DoC after traumatic brain injury. The primary hypothesis is that repeated sessions of alpha tACS will improve the level of consciousness, compared to baseline and non-stimulation periods, by reinforcing power and functional connectivity in the alpha band.\n\nThis trial adopts a Single-Case Experimental Design (SCED), a robust methodology particularly suited to rare and heterogeneous clinical populations such as DoC. Five adult patients (aged 18-70 years) with DoC persisting for 3-12 months post-trauma will be included. Each participant will undergo six consecutive phases over three months: three non-stimulation (baseline\u002Fwashout) periods and three stimulation periods, each period lasting two weeks, in an A-B-A-B-A-B sequence. This intra-subject design allows each patient to serve as their own control, maximizing sensitivity to individual changes and limiting confounding by clinical heterogeneity.\n\nThe primary outcome measure is the change in the Simplified Evaluation of Consciousness Disorders (SECONDS) score, a validated clinical scale routinely used in DoC assessment. SECONDS will be measured three times weekly throughout the study. Secondary outcomes include: (1) EEG-based classification of consciousness state using an established machine-learning algorithm, (2) spectral power and functional connectivity changes in the alpha band, and (3) resting-state fMRI measures of DMN connectivity. These multimodal assessments aim both to provide objective evidence of clinical improvement and to explore the underlying neurophysiological mechanisms of tACS.\n\nSafety and tolerability are monitored. Previous studies confirm that tACS is safe and well-tolerated, with only minor, transient side effects (tingling, scalp redness, phosphene perception). The study also involves EEG and MRI recordings, both of which are non-invasive and carry only minimal risks.\n\nThis study, although limited to five patients, is designed to provide rigorous individual-level evidence of efficacy and mechanistic plausibility. If results demonstrate consistent clinical and neurophysiological improvements, they will justify the design of a larger confirmatory trial and contribute to the development of novel therapeutic approaches for this severely disabled population.",[29],[256,257,258,259,260],"disorders of consciousness","tACS","tES","transcranial electric stimulation","traumatic brain injury","2025-10-02",{"date":263,"type":42},"2025-10-09",{"date":265,"type":21},"2026-01-01",{"date":267,"type":21},"2028-06-01",{"name":269,"class":49},"Hospices Civils de Lyon",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":280,"conditions":281,"keywords":285,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":50},"100396710","prognostic-factors-to-regain-consciousness-100396710","NCT04445649","Prognostic Factors to Regain Consciousness","Investigation of Prognostic Factors to Regain Consciousness in Neurological Early Rehabilitation","Inclusion Criteria:\n\n* early neurological rehabilitation (phase B)\n* stroke, traumatic brain injury, hypoxic-ischemic encephalopathy\n* disorder of consciousness (coma, UWS, MCS)\n* at minimum two weeks after disease onset\n* admission to intensive care unit\n* written consent from the patient's legal representative\n* exclusion of pregnancy\n\nExclusion Criteria:\n\n* insufficient cardiorespiratory stability\n* fractures or severe infratentorial brain injuries leading to impaired auditory evoked - potentials\n* previous brain damage\n* mental disorders (dementia, depression)\n* colonization with multi-resistant pathogens\n* MRI contraindications\n* claustrophobia\n* weight \\> 120 kg","85 Years",{"count":279,"type":21},130,"The study aims to identify factors that predict the medium and long-term outcome of patients with disorders of consciousness (DOC) undergoing early neurological rehabilitation.\n\nIn this prospective, observational study, 130 DOC patients are going to be included (36 months). At study entry, different routine data, disease severity and functional status are documented for each patient. In addition, MRI, EEG and evoked potentials are measured within the first week. The level of consciousness is recorded with the Coma-Recovery-Scale-Revised and serves as the primary outcome parameter. Complications, comorbidities, functional status and leve of consciousness are assessed weekly. After eight weeks, the measurement of the MRI, the EEG and the evoked potentials are repeated. After 3, 6 and 12 months, the Glasgow Outcome Scale-Revised is used to followed up the current status of the patients.",[30,29,282,283,284],"Traumatic Brain Injury","Stroke","Hypoxic-Ischemic Encephalopathy",[179,286,287,288],"Prognosis","Outcome","Level of consciousness","2025-09-18",{"date":291,"type":42},"2025-09-19",{"date":293,"type":42},"2020-06-15",{"date":295,"type":21},"2027-12-15",{"name":188,"class":49},{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":4,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":277,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":308,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":312,"startDateStruct":313,"completionDateStruct":314,"leadSponsor":316,"locationsCount":50},"100396505","effectiveness-of-music-therapy-on-level-of-consciousness-100396505","NCT04442971","Effectiveness of Music Therapy on Level of Consciousness","Investigation of the Effectiveness of Music Therapy on the Level of Consciousness of Neurological Early Rehabilitation Patients","Inclusion Criteria:\n\n* early neurological rehabilitation (phase B)\n* traumatic brain injury\n* disorder of consciousness (coma, UWS, MCS)\n* at minimum two weeks after disease onset\n* admission to intensive care unit\n* written consent from the patient's legal representative\n* Exclusion of pregnancy\n\nExclusion Criteria:\n\n* insufficient cardiorespiratory stability\n* fractures or severe infratentorial brain injuries leading to impaired auditory evoked potentials\n* previous brain damage\n* Known mental disorders (dementia, depression)\n* hearing loss or deafness in one or two ears\n* wounds that do not allow you to wear headphones\n* colonization with multi-resistant pathogens\n* MRI contraindications\n* claustrophobia\n* weight\\>120 kg",{"count":145,"type":21},[24],"It is known that even in patients with severe disorders of consciousness (DOC), the perception of known stimuli triggers emotional reactions that can be interpreted as an expression of a residual function of consciousness. Music therapy has a long tradition in neurological rehabilitation. Frequently, active therapies with own music making and singing are implemented in clinical settings. In DOC patients, it is more likely to use passive music listening. However, findings on effectiveness are limited, as only a few studies have systematically investigated the effects of music therapy in this population. Therefore, the investigators want to investigate the effectiveness of passive listening to preferred music on the level of consciousness.",[30,282,29],[309,67,310,311],"neurological rehabilitation","level of consciousness","default mode network",{"date":291,"type":42},{"date":293,"type":42},{"date":315,"type":21},"2026-12-15",{"name":188,"class":49},{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":322,"acronym":323,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":325,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":327,"conditions":328,"keywords":329,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":213},"100496169","emotional-and-neutral-sounds-for-neurophysiological-prognostic-assessment-of-critically-ill-patients-with-a-disorder-of-consciousness-100496169","NCT05740735","Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness","Emotional and Neutral Sounds for Neurophysiological Prognostic Assessment of Critically Ill Patients With a Disorder of Consciousness (DOC)","ExpressComa","Inclusion Criteria:\n\n* patients hospitalized in ICU for cardiac arrest, stroke, subarachnoid haemorrhage or head trauma,\n* persistent disorder of consciousness (DoC) 12 hours after sedation weaning or patient who has benefited from a prognostic assessment for persistent DoC and who has had in this assessment an evaluation by late PEA with MMN and P300 responses only to neutral sounds (\"beep\" and patient's first name pronounced by an unfamiliar voice) there is more than 6 months (since April 2022)\n\nExclusion Criteria:\n\n* Moribund patient\n* Uncontrolled Shock during the neurophysiological evaluation\n* Sedated patient\n* Minor patient\n* brain death\n* Known deafness\n* Pregnant woman\n* Prior inclusion in the study\n* Patient not affiliated to a social security system\n* Implementation of limitations and stop of active therapies\n* Patient under legal protection\n* Patient benefiting from State Medical Aid",{"count":326,"type":21},114,"The purpose of this study is to determine if the use of emotional sound as subject own name (SON) pronounced by a familiar voice (FV) compared to SON pronounced by a non-familiar voice (NFV) during event related potential (ERP) produced a more reliable neurophysiological P300 responses, and to assess the prognostic value of this P300 responses induced by the SON with a FV.",[29],[330,331,27,332,333,334,335,336,337,338,339],"Disorder of consciousness","Cardiac arrest","Intensive care unit","Neuro-prognostication","Event related potential (ERP)","Electroencephalogram (EEG)","Emotional sounds","Subject own name (SON)","P300","Mismatch negativity (MMN)","2025-09-05",{"date":342,"type":42},"2025-09-12",{"date":344,"type":42},"2024-03-25",{"date":346,"type":21},"2026-09",{"name":348,"class":49},"Assistance Publique - Hôpitaux de Paris",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":357,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":359,"conditions":360,"keywords":361,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":50},"100440051","an-ethical-approach-to-detecting-covert-consciousness-100440051","NCT05010265","An Ethical Approach to Detecting Covert Consciousness","An Ethical Approach to Detecting Covert Consciousness: Data-Driven Neuroethics for Consciousness Detection (DECODE)","DECODE","Inclusion Criteria:\n\n* Patients with prior or ongoing participation as subject in a research study using neurotechnologies for diagnosis and prognosis of disorders of consciousness (DoC) at Mass General Brigham\n* Patients capable of understanding and answering questions in English\n* Patients cble to provide informed consent\n* Patients for whom MRI \u002F EEG are administered for clinical detection of consciousness and\u002For neuroprognostication\n* Family member or surrogate caregiver of patients who previously participated or are currently participating in a research study using neurotechnologies for diagnosis and prognosis of DoC at Mass General Brigham.\n* Family Members \u002F Surrogates capable of understanding and answering questions in English\n* Family Members \u002F Surrogates able to provide informed consent\n* Family member or surrogate caregiver of patients for whom MRI \u002F EEG are administered for clinical detection of consciousness and\u002For neuroprognostication\n* Research Investigators involved with research responsibilities in designing or testing neurotechnologies on patients with DoC.\n* Clinicians with clinical responsibilities caring for patients in behaviorally unresponsive state, defined as coma, vegetative state (VS), and low-level minimally conscious state (MCS).\n* Selected leaders and advisors (Community and Thought Leaders) from brain injury associations and advocacy organizations, and policy-makers involved in decision-making impacting patients with DoC.\n\nExclusion Criteria:\n\nNone",{"count":358,"type":21},70,"This study aims to develop an ethical approach to developing and deploying novel neurotechnologies to aid in the detection of consciousness and prediction of recovery after brain injury.",[29],[362],"Disorders of consciousness, Advanced neuroimaging",{"date":364,"type":42},"2025-09-11",{"date":366,"type":42},"2022-02-01",{"date":368,"type":21},"2027-07",{"name":370,"class":49},"Massachusetts General Hospital",{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":22,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100598872","vagal-nerve-stimulation-to-treat-disorders-of-consciousness-100598872","NCT07077135","Vagal Nerve Stimulation to Treat Disorders of Consciousness","Transcutaneous Vagal Nerve Stimulation to Treat Disorders of Consciousness","REVELATION","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* any acquired cerebral damage of any known etiology;\n* diagnosis of coma, UWS, or MCS with the corresponding basal CRS-R (Coma Recovery Scale-Revised) score performed during the screening period from 7 to 15 days since admission in ICU;\n* intact ear skin;\n* availability of the device.\n\nExclusion Criteria:\n\n* Patients with severe hemodynamic, respiratory, infectious, or neurological instability requiring active treatment requiring mechanical ventilation or vasoactive drugs or pending acute neurosurgical interventions;\n* Need for deep sedation, including general anesthetics (e.g., propofol) or a combination of central-acting sedatives;\n* Documented pregnancy;\n* Active implant (e.g., pacemaker, cochlear implant);\n* History of previous serious neurological disability before the brain injury;\n* Seizures or status epilepticus as cause sustaining the disorder of consciousness;\n* Patients already enrolled in another ongoing interventional trial.",{"count":380,"type":21},106,[24],"This interventional study aims to assess the clinical efficacy of transcutaneous auricular vagal nerve stimulation (taVNS) against sham stimulation on the recovery of consciousness in patients with disorders of consciousness. The main question it aims to answer is: will taVNS improve patients' behavioral scores or will it produce an improvement in the diagnosed level of consciousness? Researchers will compare the results with non-stimulated unconscious patients to see if the re-gain of consciousness is faster in the treated group.\n\nParticipants will undergo taVNS stimulation using the Parasym device or sham stimulation will be applied from the time of enrolment.\n\nActive stimulations will be carried out for 60 minutes twice daily during the acute phase and daily during the rehabilitation phase.",[29],[385,386,387,388,33],"vagal nerve stimulation","transcutaneous","auricolar","disorder of consciousness","2025-07-11",{"date":391,"type":42},"2025-07-22",{"date":393,"type":21},"2025-09-01",{"date":395,"type":21},"2028-09-01",{"name":397,"class":49},"Fondazione IRCCS San Gerardo dei Tintori",11,{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":411,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":50},"100493567","music-intervention-and-transcranial-electrical-stimulation-for-neurological-diseases-100493567","NCT05706831","Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases","Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases","Inclusion Criteria:\n\n* Age \\> 18 years\n* Post-stroke aphasia\n* Post-stroke neglect\n* Patients with disorders of consciusness (DOC)\n\nExclusion Criteria:\n\n* No auditory injury\n* no hystory of neurological disease\n* No hystory of psychiatric disease\n* Previous stroke\n* use of alcohol and drugs\n* premorbid dementia",{"count":407,"type":21},90,[24],"The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are:\n\n* to evaluate the residual neuroplastic processes in DOC state related to music exposure\n* to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation\n* to evaluate the impact of this intervention on caregiver's burden and psychological distress.\n\nParticipants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.",[29,283],[412,99,413,414,415,283],"music stimulation","Aphasia","Neglect","DOC","2025-05-30",{"date":418,"type":42},"2025-06-04",{"date":420,"type":42},"2022-09-01",{"date":133,"type":21},{"name":423,"class":49},"Istituti Clinici Scientifici Maugeri SpA",{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":17,"minAge":431,"maxAge":18,"enrollmentInfo":432,"targetDuration":434,"studyType":90,"phases":4,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":446},"100366417","evaluation-of-the-musicca-for-measuring-awareness-100366417","NCT04050995","Evaluation of the MuSICCA for Measuring Awareness","Evaluating the Validity, Reliability, and Clinical Utility of the Music Therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA) in Children and Youth With Prolonged Disorders of Consciousness","Inclusion Criteria:\n\n* Between 2-18 years of age\n* Assessed by the interdisciplinary team as having a disorder of consciousness\n* Be under active investigation for diagnosis of DOC\n\nExclusion Criteria:\n\n* Known hearing impairments\n* Known profound visual impairments\n* Known musicogenic epilepsy\n* Seizure disorders that cause frequent and\u002For prolonged seizures\n* English not first language","2 Years",{"count":433,"type":21},80,"2 Weeks","Prolonged Disorders Of Consciousness (PDOC) include the Vegetative State (VS) and the Minimally Conscious State (MCS) that persist for longer than four weeks. This research seeks to evaluate the validity (accuracy), reliability, and clinical utility (usefulness to clinicians) of the children's version of the Music Therapy Assessment Tool for Awareness in Disorders of Consciousness (MATADOC). The paediatric version is called the Music therapy Sensory Instrument for Cognition, Consciousness and Awareness (MuSICCA). The MATADOC is known to be accurate in diagnosis and has been shown to be clinically useful when working with adults. However, currently, there are no equivalent measures that have been rigorously tested for working with children. Therefore, there is a significant need for a valid and reliable measure, especially when the consequences of misdiagnosis include insufficient care provision, unsuitable treatment programmes, poor identification of intentions to communicate, and insufficient evidence for making difficult decisions around withdrawal of hydration and nutrition.\n\nThe study will invite participants aged 2-18 years, who the medical team suspect of having a PDOC, from various medical facilities in the UK, Ireland and other English-speaking countries. Parental\u002Fcarer consent will be required for inclusion in the study.\n\nData collection will occur over 3 years. Each participant will be involved once for a maximum of 7 assessment sessions (4 for the MuSICCA, 1 for the Coma Recovery Scale - Revised (CRS-R), 1 for the Coma\u002FNear Coma Scale (CNC), and 1 for the Nociception Coma Scale Revised (NCS-R)). The MuSICCA assessment protocol involves presenting musical stimuli in three modalities (visual, auditory, and tactile). The participants will be instructed to respond to stimuli and commands. Sessions will be recorded using audio-visual equipment and physical responses will be noted on documentation. The information gained will inform diagnosis and treatment. The participants' behaviours will also be scored on the CRS-R (the gold standard for diagnosis of DOC in adults), the CNC and the NCS-R.",[29],"2025-04-24",{"date":439,"type":42},"2025-04-30",{"date":441,"type":42},"2022-04-01",{"date":443,"type":21},"2027-12-01",{"name":445,"class":49},"The Children's Trust, United Kingdom",3,{"id":448,"slug":449,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":460,"conditions":461,"keywords":462,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":475},"100455638","phase-2-apomorphine-in-severe-brain-injured-patients-100455638","NCT05213169","Apomorphine in Severe Brain-injured Patients","Randomized Controlled Trial of Apomorphine in Severe Brain-injured Patients: a Double-blind Behavioral and Neuroimaging Study","APODoC","Inclusion Criteria:\n\n* 18-80 years old.\n* Clinically stable, not dependent on medical ventilators for respiration.\n* Diagnosed as in an unresponsive wakefulness syndrome or minimally conscious state according to the international criteria and based on at least 2 consistent CRS-R in the last 14 days (one CRS-R in the last 7 days).\n* More than 4 weeks post-insult.\n* No serious neurological impairments others than related to their acquired brain injury.\n* No neurological medications other than anti-epileptic or anti-spasticity drugs within the last two weeks.\n* No use of dopaminergic medications other than apomorphine within the last two weeks.\n* Informed consent from legal representative of the patient (if patients recover, their consent will also be obtained).\n\nExclusion Criteria:\n\n* Use of dopamine agonists or antagonists (e.g. amantadine, bromocriptine, l-dopa, pramipexole, ropinirole, amphetamine, bupropion, methylphenidate \u002F risperidone, haloperidol, chlorpromazine, flupentixol, clozapine, olanzapine, quetiapine) in the last 4 weeks or 4 half-lives of the drug.\n* Use of drugs with known significant prolongation of the QT interval (e.g. class 1 antiarrythmics, sotalol, macrolides, quinolones, antipsychotic drugs, tricyclic antidepressants. Methadone, chloroquine, quinine)\n* A corrected QT interval over 480ms (calculated using Bazett's formula on a standard 12-lead ECG recorded in the last 14 days) or other risk factors for arrhythmia (congestive cardiac failure, severe hepatic impairment or significant electrolyte disturbance).\n* A history of previous neurological functional impairment.\n* Contraindication to MRI, EEG, or PET (e.g., electronic implanted devices, active epilepsy, external ventricular drain).\n* Use of nitrates or other vasodilators, central nervous system acting agents such as barbiturates, morphine and related drugs (relative exclusion criterion)",{"count":456,"type":21},48,[458,459],"PHASE2","PHASE3","Background:\n\nPatients who survive severe brain injury may develop chronic disorders of consciousness (DoC). Treating these patients to improve recovery is extremely challenging because of scarce and inefficient therapeutical options. Among pharmacological treatments, apomorphine, a potent direct dopamine agonist, has exhibited promising behavioral effects, but its true efficacy and its mechanism remains unknown. This randomized controlled study aims to verify the effects of apomorphine subcutaneous infusion in patients with disorders of consciousness and investigate the neural networks targeted by this treatment.\n\nMethods\u002Fdesign:\n\nThe double-blind randomized controlled trial will include 48 patients: 24 patients will be randomly assigned to the apomorphine and 24 to the placebo group. Investigators and the patients will be unaware of the nature of the treatment rendered.\n\nPrimary outcome will be determined as behavioral response to treatment as measured by changes of diagnosis using the Coma Recovery Scale - Revised (CRS-R), while secondary outcome measures will include the Nociception Coma Scale - Revised (NCS-R), Disability Rating Scale (DRS), Wessex Head Injury Matrix (WHIM), circadian rhythm using actimetry, electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). The Glasgow Outcome Scale - Extended (GOS-E) and a phone-adapted version of the CRS-R will be used for long-term follow-up.\n\nStatistical analyses will focus on the detection of changes induced by apomorphine treatment at the individual level (comparing data before and after treatment) and at the group level (comparing responders with non-responders). Response to treatment will be measured at four different levels: 1. behavioral response (CRS-R, NCS-R, DRS, WHIM, GOS-E, phone CRS-R), 2. brain metabolism (PET), 3. network connectivity (resting-state fMRI, clinical EEG and high-density EEG) and 4. Circadian rhythm changes (actimetry, body temperature, 24h-EEG).\n\nDiscussion:\n\nApomorphine is a promising and safe strategy for the treatment of DoC but efficacy, profile of the responding population and underlying mechanism remain to be determined. This trial will provide unprecedented data that will allow to investigate the response to apomorphine using multimodal methods and shed new light on the brain networks targeted by this drug in terms of behavioral response, functional connectivity and metabolism.",[29],[463,464,465,466],"unresponsive wakefulness syndrome","minimally conscious state","apomorphine","treatment","2025-04-10",{"date":469,"type":42},"2025-04-15",{"date":471,"type":42},"2021-06-18",{"date":133,"type":21},{"name":474,"class":49},"University of Liege",4,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":484,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":492,"lastUpdatePostDateStruct":493,"startDateStruct":495,"completionDateStruct":497,"leadSponsor":498,"locationsCount":446},"100555672","efficacy-and-safety-of-spinal-cord-stimulation-in-patients-with-spinal-cord-stimulation-100555672","NCT06515132","Efficacy and Safety of Spinal Cord Stimulation in Patients With Spinal Cord Stimulation","Efficacy and Safety of Spinal Cord Stimulation in Patients With Disorders of Consciousness: A Multicenter, Double-blind, Randomized Controlled Trail","SCORS-DOC","Inclusion Criteria:\n\n* Male and female patients between the ages of 18 and 65, experiencing DOC for a duration ranging from 3 months to 1 year following brain disease.\n* Patients diagnosed with DOC as a consequence of traumatic brain injury, hypertensive intracerebral hemorrhage, or severe cerebral infarction.\n* Patients exhibiting stable cerebral anatomy and no need for further cranioplasty or hydrocephalus shunt.\n* Patients in MCS, who fulfill at least one of the following criteria: ① Demonstrating an oriented response to noxious stimuli; ② Exhibiting sustained eye tracking behavior; ③ Displaying purposeful movements; ④ Manifesting comprehension of language or emotions and actions (often observed in specific environments such as when hearing family members crying).\n* The vital signs and state of consciousness are stable: normal body temperature, the spontaneous breathing is stable (minimal sputum production and respiratory stability without oxygen supplementation for at least 2 hours); there is no significant change in the level of consciousness for at least 1 month and more.\n* Presence of short-latency responses (N20\u002FP25) on somatosensory evoked potentials (SEP) recorded from the median nerve in the upper limbs.\n* Written informed consent obtained from legal guardians or representatives.\n\nExclusion Criteria:\n\n* Patients with a history of severe neurological or psychiatric disorders, or other significant diseases impacting prognosis prior to the onset of DOC;\n* Patients with contraindications for surgery, such as acute infections or coagulation disorders;\n* Patients who require short-wave diathermy treatment and are unable to undergo neurostimulation;\n* Patients with hypoxic brain injury due to suffocation, cardiac arrest, or respiratory arrest;\n* Patients with brainstem hemorrhage;\n* Pregnant women;\n* Patients who voluntarily request SCS implantation but are unwilling to cooperate with the research protocol;\n* Participants in other clinical trials.","65 Years",{"count":486,"type":21},50,[24],"Investigating the efficacy and safety of spinal cord stimulation for patients with disorders of consciousness.",[29,490],"Spinal Cord Stimulation",[29,490,203],"2025-01-04",{"date":494,"type":42},"2025-01-07",{"date":496,"type":21},"2025-01-10",{"date":153,"type":21},{"name":212,"class":49},{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":17,"minAge":507,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":525,"locationsCount":50},"100564908","improving-the-diagnostic-accuracy-of-children-with-doc-ideal-desire-100564908","NCT06635291","Improving the Diagnostic Accuracy of Children with DoC (IDeAl DesiRE)","Improving the Diagnostic Accuracy of Children with Disorders of Consciousness in the REhabilitation Process (IDeAl DesiRE)","IDeAl DesiRE","Inclusion Criteria:\n\n* suffering from an ABI due to: traumatic brain injury, hypoxic events\u002Fanoxia, cerebral infections, cerebrovascular accident;\n* age: 2 months-25.11 years;\n* having a Glasgow Coma Scale (GCS; Teasdale \\& Jennett, 1974) at injury or onset ≤8);\n* being in vegetative state (VS) or minimally conscious state (MCS) at admission;\n* being in subacute or chronic phase.\n\nExclusion Criteria:\n\n\\- ABI due to brain tumor or neurodegenerative disease.","2 Months","25 Years",{"count":510,"type":21},113,"The present study aims to investigate the clinical evolution of children with severe ABI and DoC both by using the traditional behavioral scales, namely the CRS-R, CRS-P and CNCS, and by trying to establish whether it is possible to identify any clinical markers of Emergency (E-Markers). E-Markers are behaviors that indicate a content of consciousness irrespective of the processes investigated by behavioral scales, thus they could be combined with the items of these scales to improve the diagnosis.\n\nA particular focus will be given to the identification of specific E-Markers for children aged less than 12 months, for which the CRS-P scale cannot be used. In this case, the E-markers will be compared with the specific developmental stages of newborns, giving great importance to motor abilities.",[65,29],[514,388,515,516,517,518],"brain injury","diagnosis","behavioral scale","children","pediatric","2024-12-11",{"date":521,"type":42},"2024-12-16",{"date":523,"type":42},"2024-05-20",{"date":133,"type":21},{"name":526,"class":49},"IRCCS Eugenio Medea",{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":534,"maxAge":166,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":537,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":549,"locationsCount":551},"100349236","awareness-detection-and-communication-in-disorders-of-consciousness-100349236","NCT03827187","Awareness Detection and Communication in Disorders of Consciousness","EEG Based Awareness Detection and Communication in Prolonged Disorders of Consciousness and Physical Disability","Study 1 - Initial assessment\u002Fscreening\n\nInclusion Criteria:\n\n* Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome \u002F completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.\n* acute, post-acute patients where appropriate\n\nExclusion Criteria:\n\n* Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.\n* Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning\n* Where English is not the individual's first language\n* Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.\n\nStudy 2 - BCI training\n\nInclusion Criteria:\n\n\\- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and\u002For those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.\n\nExclusion Criteria:\n\n\\- Participants who have shown no active brain responses in study 1 where the difference between baseline","10 Years",{"count":536,"type":21},30,[24],"STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases a person can be left in a state where they are \"awake\" but unaware, which is called unresponsive wakefulness syndrome (UWS, previously known as a vegetative state). Up to 43% of patients with a UWS diagnosis, regain some conscious awareness, and are then reclassified as minimally conscious after further assessment by clinical experts. Many of those in the minimally conscious state (MCS) and all with unresponsive wakefulness syndrome (UWS) are incapable of providing any, or consistent, overt motor responses and therefore, in some cases, existing measures of consciousness are not able to provide an accurate assessment. Furthermore, patients with locked-in syndrome (LIS), which is not a disorder of consciousness as patients are wholly aware, also, struggle to produce overt motor responses due to paralysis and anarthria, leading to long delays in accurate diagnoses using current measures to determine levels of consciousness and awareness. There is evidence that LIS patients, and a subset of patients with prolonged disorders of consciousness (DoC), can imagine movement (such as imagining lifting a heavy weight with their right arm) when given instructions presented either auditorily or visually - and the pattern of brain activity that they produce when imagining these movements, can be recorded using a method known as electroencephalography (or EEG). With these findings, the investigators have gathered evidence that EEG-based bedside detection of conscious awareness is possible using Brain- Computer Interface (BCI) technology - whereby a computer programme translates information from the users EEG-recorded patterns of activity, to computer commands that allow the user to interact via a user interface. The BCI system for the current study employs three possible imagined movement combinations for a two-class movement classification; left- vs right-arm, right-arm vs feet, and left-arm vs feet. Participants are trained, using real-time feedback on their performance, to use one of these combinations of imagined movement to respond to 'yes' or 'no' answer questions in the Q\\&A sessions, by imagining one movement for 'yes' and the other for 'no'. A single combination of movements is chosen for each participant at the outset, and this participant-specific combination is used throughout their sessions. The study comprises three phases. The assessment Phase I (sessions 1-2) is to determine if the patient can imagine movements and produce detectable modulation in sensorimotor rhythms and thus is responding to instructions. Phase II (sessions 3-6) involves motor-imagery (MI) -BCI training with neurofeedback to facilitate learning of brain activity modulation; Phase III (sessions 7-10) assesses patients' MI-BCI response to closed questions, categorized to assess biographical, numerical, logical, and situational awareness. The present study augments the evidence of the efficacy for EEG-based BCI technology as an objective movement-independent diagnostic tool for the assessment of, and distinction between, PDoC and LIS patients.",[29,540,541,283,542],"Paralysis","Motor Neuron Disease","Physical Disability","2024-12-09",{"date":545,"type":42},"2024-12-13",{"date":547,"type":42},"2022-02-08",{"date":75,"type":21},{"name":550,"class":49},"University of Ulster",18,{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":4,"eligibilityCriteria":557,"healthyVolunteers":558,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":22,"phases":560,"briefSummary":561,"conditions":562,"keywords":564,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":50},"100536700","electro-acupuncture-to-treat-disorder-of-consciousness-100536700","NCT06268236","Electro-acupuncture to Treat Disorder of Consciousness","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. With cerebral damage due to TBI；\n3. Diagnosed with UWS or MCS based on at least two CRS-R assessments;\n4. From 4 to 16 weeks from the onset of brain injury;\n5. Informed consent obtained.\n\nExclusion Criteria:\n\n1. With a history of neurological or psychiatric disorder prior to the brain injury;\n2. With uncontrolled seizures or status epilepticus;\n3. Unstable vital signs and requiring the use of vasoactive agents;\n4. With the use of general anesthetics or central acting sedative;\n5. Without intact skin at acupoints or sham points;\n6. Concomitant medical illness that would interfere with the outcome assessments and\u002For follow-up\n7. Pregnant patients;\n8. Currently participating in other investigational trials;\n9. High likelihood of not adhering to the study treatment or the follow-up regimen",true,{"count":486,"type":21},[24],"With the rapid development of life support technology, more and more people can survive severe brain injury. Some survivors regain consciousness after a period of coma, however, many patients develop prolonged disorders of consciousness (DOC), which poses a therapeutic challenge for clinicians and a heavy burden for their families. The investigators design an Electro-acupuncture to treat disorder of consciousness (AcuDoc) trial with the aim of validating the clinical effect of electroacupuncture in treating DOC and exploring its therapeutic mechanisms by integrating EEG, neuroimaging, evoked potential tests, and behavioral assessments.",[29,563],"Electroacupuncture",[565,330,566,567,568],"Acute brain injury","Electro-acupuncture","Awakening","Brain functional network","2024-09-12",{"date":571,"type":42},"2024-09-19",{"date":573,"type":42},"2024-01-01",{"date":575,"type":21},"2026-01-31",{"name":577,"class":49},"The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine",{"id":579,"slug":580,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":583,"acronym":4,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":249,"enrollmentInfo":585,"targetDuration":4,"studyType":22,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":594,"leadSponsor":596,"locationsCount":50},"100556628","effects-of-rtms-with-different-stimulation-spots-in-patients-with-disorders-of-consciousness-100556628","NCT06527573","Effects of rTMS With Different Stimulation Spots in Patients With Disorders of Consciousness","Targeting Anterior or Posterior, Where is Better for DOC","Inclusion Criteria:\n\n1. acquired brain injuries less than 1 year and more than 28 days in DOC;\n2. clinical diagnosis of DOC Disease;\n3. no medical history of neuropsychiatric diseases;\n4. no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;\n5. stable state of disease and vital signs;\n6. the integrity of the individualized stimulation target cortex are verified by MRI.\n\nExclusion Criteria:\n\n1. patients in other non-invasive or invasive neuroregulation trials;\n2. motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;\n3. uncontrolled epilepsy, seizure within 4 weeks before enrollment;\n4. metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.",{"count":586,"type":21},84,[24],"Disorders of consciousness are a state in which consciousness is affected by brain damage, resulting in dysfunctions in alertness, awareness, and behavior. Patients with disorders of consciousness can be categorized into coma, unresponsive arousal syndrome（UWS）, and minimally conscious states（MCS）. Common causes include craniocerebral trauma and non-craniocerebral trauma causes such as stroke and ischemic-hypoxic encephalopathy. The number of patients with disorders of consciousness is rapidly increasing worldwide and is not only affecting the lives of individuals and their families, but is becoming a serious public health threat.Transcranial magnetic stimulation uses an electromagnetic pulse to induce focalised neural depolarisation and firing. Repeated transcranial magnetic stimulation, compared with single pulse transcranial magnetic stimulation, can influence brain plasticity and cortical organisation through alterations of neuronal excitability and is now being used to improve consciousness and functional recovery in patients with disorders of consciousness. However, the optimization of TMS stimulation parameters has become one of the key factors affecting the therapeutic efficacy, especially the choice of treatment location.\n\nMethod:This study is a randomized double-blind controlled trial.And eighty-four patients are expected to be recruited and they will be randomly assigned in a 1:1:1 ratio to two test groups and one control group of 28 patients each.. Each patient receives a one-week period of repetitive transcranial magnetic stimulation at 10 Hz twice daily for a total of 14 treatments. Primary and secondary evaluation indices will be performed at each baseline and after rTMS treatment. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG and TMS-EEG will be also recorded to investigate the neurophysiological correlates by rTMS.\n\nDiscussion:This study will contribute to the selection of therapeutic target locations for rTMS in patients with disorders of consciousness and has the potential to explore mechanisms of consciousness and to validate the role of rTMS parameter optimization in patients with disorders of consciousness using randomized controlled trials",[29],"2024-07-25",{"date":592,"type":42},"2024-07-30",{"date":592,"type":21},{"date":595,"type":21},"2026-06-30",{"name":597,"class":49},"Zhujiang Hospital",{"id":599,"slug":600,"hasResults":11,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":249,"enrollmentInfo":605,"targetDuration":4,"studyType":22,"phases":606,"briefSummary":607,"conditions":608,"keywords":610,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":613,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":50},"100453627","effects-of-individualized-rtms-in-doc-patients-100453627","NCT05187000","Effects of Individualized rTMS in DOC Patients","Effect of Individualized Repetitive Transcranial Magnetic Stimulation (rTMS) in Patients With Disorder of Consciousness","Inclusion Criteria:\n\n1. acquired brain injuries less than 1 year and more than 28 days in DOC;\n2. clinical diagnosis of DOC Disease;\n3. no medical history of neuropsychiatric diseases;\n4. no contraindications for rTMS or EEG, no sedatives in use or other drugs that might interfere with brain stimulation, such as Na+ or Ca2+ channel blockers or NMDA receptor antagonists;\n5. stable state of disease and vital signs;\n6. the families of the patients volunteered the patient to participate in the study and provided signed informed consent;\n7. the integrity of the individualized stimulation target cortex are verified by MRI.\n\nExclusion Criteria:\n\n1. patients in other non-invasive or invasive neuroregulation trials;\n2. motor evoked potential (MEP) in M1 region cannot be induced by TMS pulse;\n3. uncontrolled epilepsy, seizure within 4 weeks before enrollment;\n4. metallic implant in the skull, pacemaker, craniotomy under the stimulated site, implanted brain device.",{"count":536,"type":21},[24],"Background: Disorder of consciousness(DOC) is a series of arousal and cognitive disorders secondary to the most severe brain injury. Once a patient is diagnosed with a DOC, a poor prognosis is assumed and the rehabilitation for whom is greatly limited. Therefore, the treatment of DOC poses extraordinary challenges. Various treatments protocols have been reported of successful in promoting rehabilitation of DOC patients. Repetitive transcranial magnetic stimulation(rTMS), as a non-invasive brain stimulation technique, has shown potentials for consciousness rehabilitation of DOC patients as it is effective in regulating the central nervous system.\n\nMethods and design: This protocol is a double-blind randomized sham-controlled crossover trial. Totally 30 participants will be randomly assigned to either group 1 or group 2 in a 1:1 ratio, with 15 patients in each group. Each patient will received 20 sessions, in which 10 sessions will be active and 10 will be sham, separated by 10-days washout period. The active-rTMS will include 10 Hz rTMS over the individual-targeted area on each participants. Primary and secondary evaluating indicators will be performed at each baseline and after rTMS treatment. Primary outcome will be determined as behavioral response to treatment as measured using the Coma Recovery Scale - Revised (CRS-R). Resting-state high-density EEG will be also recorded to investigate the neurophysiological correlates by rTMS.\n\nDiscussion:This study will contribute to define the role of rTMS for the treatment of DOC patients and characterise the neural correlates of its action. The investigators proposed a method of individualized target selection for DOC patients based on the existing gold standard CRS-R score and MRI, and used a cross randomized controlled trial to verify the role of rTMS in DOC treatment.",[29,609],"Transcranial Magnetic Stimulation",[29,611,612],"repetitive transcranial magnetic stimulation","randomized control trial",{"date":614,"type":42},"2024-07-26",{"date":616,"type":42},"2021-07-05",{"date":618,"type":21},"2025-03-31",{"name":620,"class":49},"Qiuyou Xie"]