[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629284":3},{"organization":4,"outcomesModule":7,"designInfo":47,"detailedDescription":57,"studyPopulation":46,"armGroups":58,"interventions":71,"overallOfficials":81,"centralContacts":85,"locations":91,"responsibleParty":107,"collaborators":46,"id":109,"slug":46,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":46,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":46,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":129,"whyStopped":46,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Shanghai Mental Health Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":46},[9],{"measure":10,"description":11,"timeFrame":12},"Change of Craving assessed by Visual Analog Scale","evaluate all participants' craving for for alcohol assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 100, and higher values represent high level of craving.","Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.",[14,18,22,25,28,31,34,37,40,43],{"measure":15,"description":16,"timeFrame":17},"Number of participants who relapse","Follow up with patients after discharge, evaluate number of participants who relapse.","At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.",{"measure":19,"description":20,"timeFrame":21},"Depression status assessed by Patient Health Questionnaire-9(PHQ-9)","evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression.","Baseline and 7 days after intervention",{"measure":23,"description":24,"timeFrame":21},"Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)","evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). GAD-7 range from 0 to 21, and higher values represent more severe level of anxiety.",{"measure":26,"description":27,"timeFrame":21},"Preference in natural\u002Falcohol rewards assessed by a reward\u002Falcohol choice preference E-prime paradigm","assessed by the natural reward\u002Falcohol choice preference paradigm under simultaneous electroencephalogram and electrocardiogram recording.",{"measure":29,"description":30,"timeFrame":21},"Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm","assessed by the negative reward prediction error E-prime paradigm under simultaneous electroencephalogram and electrocardiogram recording.",{"measure":32,"description":33,"timeFrame":21},"Emotional states assessed using the Depression Anxiety Stress Scales (DASS).","Depression, anxiety and stress levels of all participants were assessed using the Depression Anxiety Stress Scales (DASS). Scores on the DASS ranged from 0 to 63, with higher scores indicating more severe levels of depression, anxiety and stress.",{"measure":35,"description":36,"timeFrame":21},"levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS)","evaluate all participants' levels of positive and negative affect by Positive and Negative Affect Schedule (PANAS).The PANAS consists of two dimensions: positive affect and negative affect, with scores ranging from 10 to 50 for each dimension, with higher scores indicating stronger positive or negative affect.",{"measure":38,"description":39,"timeFrame":21},"perceived stress assessed by Perceived Stress Scale (PSS)","evaluate all participants' the level of perceived stress by the Perceived Stress Scale (PSS). PSS range from 0 to 40, and higher values represent higher level of perceived stress.",{"measure":41,"description":42,"timeFrame":21},"Functional connectivity assessed by MRI","evaluate all participants' functional connectivity in the brain by MRI",{"measure":44,"description":45,"timeFrame":21},"Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ）","evaluate all participants' the Cognitive emotion regulation strategies by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ consists of four subscales, with scores for each subscale ranging from 4 to 20. Higher scores indicate more frequent use of the corresponding cognitive emotion regulation strategy.",null,{"allocation":48,"interventionModel":49,"interventionModelDescription":46,"primaryPurpose":50,"observationalModel":46,"timePerspective":46,"maskingInfo":51},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":52,"maskingDescription":46,"whoMasked":53},"TRIPLE",[54,55,56],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","This study employs a randomized, double-blind design to investigate the emerging non-invasive deep brain stimulation modality of temporal interference stimulation (tTIS) targeted at the amygdala, aiming to validate the efficacy and feasibility of non-invasively modulating the amygdala for the treatment of patients with alcohol use disorder (AUD). During the intervention phase, all participants will be randomly assigned to receive either active stimulation or sham stimulation. The localization of the amygdala will be modeled based on individual brain imaging data for each participant. Clinical characteristics, electroencephalography (EEG) and magnetic resonance imaging (MRI) data will be collected from all patients at baseline and post-intervention. In addition, follow-up assessments of alcohol consumption will be conducted for all participants after the intervention.",[59,65],{"label":60,"type":61,"description":62,"interventionNames":63},"tTIS stimulation group","EXPERIMENTAL","The two high-frequency electric fields of the temporal interference (TI) device are set at distinct frequencies (2 kHz and 2.010 kHz), thereby generating a low-frequency electric field (10 Hz) specifically targeted at the amygdala.\n\nFor each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session.",[64],"Device: tTIS on Amygdala, 10 Hz",{"label":66,"type":67,"description":68,"interventionNames":69},"Sham tTIS stimulation group","SHAM_COMPARATOR","The two high-frequency electric fields of the temporal interference (TI) device are set at the same frequencies (2 kHz and 2 kHz), which are specifically targeted at the amygdala. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session.",[70],"Device: tTIS on Amygdala, Sham",[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":46},"DEVICE","tTIS on Amygdala, 10 Hz","Through the transcranial electric stimulation device, the first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.010 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 10 Hz can be generated in the target area. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.",[60],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":46},"tTIS on Amygdala, Sham","The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.",[66],[82],{"name":83,"affiliation":5,"role":84},"Min Zhao, M.D, Ph.D","PRINCIPAL_INVESTIGATOR",[86],{"name":87,"role":88,"phone":89,"phoneExt":46,"email":90},"Tianzhen Chen, M.D, Ph.D","CONTACT","021-34773523","vomchan@hotmail.com",[92],{"facility":5,"status":46,"city":93,"state":46,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Shanghai","200000","China","CN",{"type":98,"coordinates":99},"Point",[100,101],121.45806,31.22222,{"lat":101,"lon":100},[104],{"name":83,"role":88,"phone":105,"phoneExt":46,"email":106},"18017311005","drminzhao@smhc.org.cn",{"type":108,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100629284",false,"NCT07472673","Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients","Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder","Inclusion Criteria:\n\n* aged 18 to 60 years old;\n* Meets the DSM-5 diagnostic criteria for alcohol use disorder;\n* Normal or corrected normal vision and hearing;\n* Able to cooperate in completing the questionnaire assessment and behavioral tests;\n* No metal implantation in the head, no history of neurological problems or head injury.\n\nExclusion Criteria:\n\n* Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;\n* serious physical or neurological illness, a diagnosis of any other psychiatric disorder under DSM-5 criteria (except for nicotine use disorder); Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).\n* any contraindications to transcranial electrical stimulation.","MALE","18 Years","60 Years",{"count":119,"type":120},60,"ESTIMATED","INTERVENTIONAL",[123],"NA","The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder.",[126],"Alcohol Use Disorder",[128],"Alcohol use disorder","NOT_YET_RECRUITING","2026-03-12",{"date":132,"type":133},"2026-03-16","ACTUAL",{"date":135,"type":120},"2026-02-15",{"date":137,"type":120},"2026-12-31",{"name":5,"class":6},1]