[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634442":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":67,"collaborators":34,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":34,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":34,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":52,"whyStopped":34,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Zhujiang Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tTIs-Active Group","EXPERIMENTAL","Participants will receive active theta-burst patterned temporal interference stimulation (tTIs) targeting the centromedian-parafascicular nuclei complex (CM-pf). The stimulation consists of 3-pulse bursts at 100 Hz, repeated at a 5 Hz (theta) rhythm. Treatment will be administered for 30 minutes per session, twice daily, for 5 consecutive days (totaling 10 sessions). The current intensity is 2 mA per channel (total 4 mA).",[13],"Device: Theta-burst Patterned Temporal Interference Stimulation (tTIs)",{"label":15,"type":16,"description":17,"interventionNames":18},"tTIs-Control Group","SHAM_COMPARATOR","Participants will receive sham stimulation using the same device and electrode placement as the active group. The device will deliver 0 mA current after a brief initial ramp-up period to mimic the skin sensation. The procedure lasts 30 minutes per session, twice daily, for 5 consecutive days (totaling 10 sessions).",[19],"Device: Sham Temporal Interference Stimulation",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Theta-burst Patterned Temporal Interference Stimulation (tTIs)","The intervention targets the CM-pf complex using two pairs of high-frequency electrodes. Carrier frequency f1 = 2 kHz and f2 = 2.1 kHz to generate a 100 Hz interference. The stimulation is delivered in theta-burst patterns (3-pulse bursts at 100 Hz, repeated at 5 Hz). Sessions last 30 minutes, administered twice daily for 5 consecutive days (totaling 10 sessions). Current intensity is 2 mA per channel.",[9],[27,28,29],"Respiratory-burst tTIs","TBS-tTIs","Non-invasive Deep Brain Stimulation",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Sham Temporal Interference Stimulation","The sham group uses the same device and electrode configuration as the active group. The device delivers 0 mA current after a 30-second ramp-up to mimic skin sensation. Sessions last 30 minutes, administered twice daily for 5 consecutive days (totaling 10 sessions).",[15],null,[36],{"name":37,"affiliation":5,"role":38},"Qiuyou Xie","STUDY_CHAIR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},"Chengwei Xu","CONTACT","86+13450457096","xuchweii@163.com",{"name":46,"role":42,"phone":47,"phoneExt":34,"email":48},"Shiying Zhuang","86+13505085958","13505085958@163.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Zhujiang Hospital of Southern Medical University","RECRUITING","Guangzhou","Guangdong","510280","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65,66],{"name":41,"role":42,"phone":43,"phoneExt":34,"email":44},{"name":46,"role":42,"phone":47,"phoneExt":34,"email":48},{"type":68,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100634442","effectiveness-of-ttis-for-improving-consciousness-in-patients-with-doc-100634442",false,"NCT07539740","Effectiveness of tTIs for Improving Consciousness in Patients With DoC","Effectiveness of Theta-Burst Patterned Temporal Interference Stimulation for Improving Awareness in Patients With Disorders of Consciousness: A Multicenter Randomized Double-Blind Controlled Trial","Inclusion Criteria:\n\n* Age: 18 to 70 years old.\n* Condition: Patients diagnosed with Disorders of Consciousness (DoC), including Vegetative State (VS)\u002FUnresponsive Wakefulness Syndrome (UWS) or Minimally Conscious State (MCS) according to international guidelines.\n* Duration: Disease course ≤ 1 year.Medical History: No history of neuro-psychiatric disorders prior to the brain injury.\n* Handedness: Right-handed.Safety: No contraindications for tTIs, EEG, or MRI.\n* Medication: Not currently using sedative drugs or medications that interfere with brain stimulation, such as Na2+ or Ca2+ channel blockers, or NMDA receptor antagonists.\n\nExclusion Criteria:\n\n* Concurrent Trials: Participation in other non-invasive or invasive neuromodulation trials.\n* Epilepsy: Uncontrolled epilepsy, defined as a seizure within 4 weeks prior to enrollment.\n* Implants: Presence of metal implants in the skull, brain pacemakers, or implanted brain devices (e.g., spinal cord stimulator).\n* Structural Issues: Skull defects at the site of stimulation that prevent the implementation of tTIs.\n* Systemic Implants: Presence of systemic metal implants, such as cardiac pacemakers.","ALL","18 Years","70 Years",{"count":80,"type":81},136,"ESTIMATED","INTERVENTIONAL",[84],"NA","The goal of this clinical trial is to learn if a new type of brain stimulation called theta-burst patterned temporal interference stimulation (tTIs) works to improve awareness in people with disorders of consciousness (DoC). The main questions it aims to answer are:\n\n1. Does tTIs help people with disorders of consciousness show more signs of awareness?\n2. Does tTIs improve the brain's ability to process information and connect different brain areas? Is tTIs safe and easy for people with disorders of consciousness to tolerate? Researchers will compare a group receiving active tTIs to a group receiving a \"sham\" stimulation (a look-alike stimulation that delivers no real current) to see if the real stimulation works better.\n\nParticipants will:Receive either active tTIs or sham stimulation twice a day for 5 consecutive days (total of 10 sessions). Undergo brain activity tests (EEG) and physical exams to check their level of awareness before and after the 5 days of treatment. Have their progress followed by researchers through phone calls at 1, 3, and 6 months after the treatment ends.",[87,88,89],"Disorders of Consciousness","Vegetative State","Minimally Conscious State",[91,92,93,94,95,96,97],"Temporal Interference Stimulation (tTIs)","Theta-burst Patterned Stimulation","Deep Brain Stimulation (Non-invasive)","Thalamic Stimulation","Centromedian-parafascicular Nuclei (CM-pf)","Perturbational Complexity Index (PCI)","Coma Recovery Scale-Revised (CRS-R)","2026-04-13",{"date":100,"type":101},"2026-04-20","ACTUAL",{"date":103,"type":101},"2026-03-08",{"date":105,"type":81},"2028-05-31",{"name":5,"class":6},1]