[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610435":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":56,"studyPopulation":52,"armGroups":57,"interventions":64,"overallOfficials":52,"centralContacts":68,"locations":74,"responsibleParty":88,"collaborators":52,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":52,"studyType":104,"phases":105,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":111,"whyStopped":52,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Shanghai Mental Health Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":42},[9],{"measure":10,"description":11,"timeFrame":12},"The change of alcohol craving","Alcohol craving will be measured by the alcohol craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of alcohol craving.","Baseline, immediately after completion of the 2-week intervention",[14,17,20,24,27,30,33,36,39],{"measure":15,"description":16,"timeFrame":12},"The change of drinking urge","Alcohol urge will be assessed using the Alcohol Urge Questionnaire (AUQ). The total score of AUQ ranges from 8 to 56, with higher scores indicating stronger urges to consume alcohol.",{"measure":18,"description":19,"timeFrame":12},"Change of the compulsive drinking behavior","Compulsive drinking behavior will be measured by the short form of the Obsessive-Compulsive Drinking Scale (OCDS). The total score of OCDS ranges from 0 to 40, with higher scores reflecting greater obsessive-compulsive thoughts and behaviors related to alcohol use.",{"measure":21,"description":22,"timeFrame":23},"Side effects of the modulation","Side effects will be assessed using a standardized adverse reaction evaluation form. The presence and severity of stimulation-related adverse reactions will be recorded for each symptom.","Immediately after each of the 20 HI-tACS sessions during the 2-week intervention period",{"measure":25,"description":26,"timeFrame":12},"Change of depressive symptoms.","Depressive symptoms will be measured using the 17-item Hamilton Depression Rating Scale (HAMD-17). The total score ranges from 0 to 52, with higher scores indicating more severe depressive symptoms.",{"measure":28,"description":29,"timeFrame":12},"Change of anxiety symptoms","Anxiety symptoms will be assessed using the 14-item Hamilton Anxiety Rating Scale (HAMA-14). The total score ranges from 0 to 56, where higher scores reflect greater anxiety severity.",{"measure":31,"description":32,"timeFrame":12},"Change of the self-control ability","Self-control ability will be measured using the Self-Control Scale (SCS). The total score ranges from 19 to 95, with higher scores of SCS indicating better self-regulation and impulse control.",{"measure":34,"description":35,"timeFrame":12},"Change of the risky decision-making performance","Risky decision-making will be assessed using the Balloon Analogue Risk Task (BART), with task performance and concurrent electroencephalography (EEG) measures related to risk-taking, decision-making, and outcome processing recorded. In addition, the Pig Dice Game will be administered during functional magnetic resonance imaging (fMRI) to assess risk-taking decision-making and associated task-related brain activity. Behavioral and neuroimaging measures derived from these tasks will be used to characterize changes in risk-related decision-making.",{"measure":37,"description":38,"timeFrame":12},"Change of the inhibitory control performance","Inhibitory control will be assessed using the Stop-Signal Task (SST), with task performance evaluated together with concurrent electroencephalography (EEG) measures related to response inhibition and inhibitory control.",{"measure":40,"description":41,"timeFrame":12},"Change of the resting state neural activity.","Resting-state functional magnetic resonance imaging (rsfMRI) will be used to assess intrinsic brain activity and functional connectivity. Resting-state electroencephalography (rsEEG) will be employed to assess spontaneous neural oscillatory activity.",[43,46],{"measure":44,"description":45,"timeFrame":12},"Individualized Electric Field Simulation","Structural magnetic resonance imaging (sMRI), including T1-weighted imaging and diffusion tensor imaging (DTI), will be used to construct individualized head models for simulation of the electric field distribution induced by HI-tACS. Individualized electric field characteristics will be estimated to characterize interindividual variability in stimulation exposure.",{"measure":47,"description":48,"timeFrame":12},"Change of the molecular-level neurochemistry","SPICE fast spectroscopic imaging will be used to assess neurochemical metabolites and their spatial distributions in the brain. Changes in multiple metabolite and neurotransmitter-related measures will be examined to characterize alterations in brain neurochemical profiles following HI-tACS.",{"allocation":50,"interventionModel":51,"interventionModelDescription":52,"primaryPurpose":53,"observationalModel":52,"timePerspective":52,"maskingInfo":54},"NA","SINGLE_GROUP",null,"TREATMENT",{"masking":55,"maskingDescription":52,"whoMasked":52},"NONE","Alcohol use disorder (AUD) has become a major social and public health problem. Persistent alcohol craving, impaired self-control, and abnormalities in decision-making and inhibitory control are important clinical and cognitive features of AUD. High-intensity transcranial alternating current stimulation (HI-tACS) is a non-invasive neuromodulation approach that may have potential therapeutic effects in individuals with AUD. However, its clinical and neurobiological effects in AUD remain unclear. The investigators hypothesize that HI-tACS may reduce alcohol craving and improve self-regulation and cognitive-control functions in individuals with AUD. This one-arm pilot study aims to evaluate the preliminary effects and tolerability of a 2-week course of HI-tACS, using clinical assessments together with electroencephalographic, and magnetic resonance imaging measures to explore potential changes in craving, self-control, risky decision-making, inhibitory control, and related neural activity. This study may provide preliminary clinical and mechanistic evidence for the further development of HI-tACS as a potential intervention for AUD.",[58],{"label":59,"type":60,"description":61,"interventionNames":62},"HI-tACS","EXPERIMENTAL","A 40-minute 15mA transcranial alternating current stimulus intervention with 77.5 Hz of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of AUD.",[63],"Device: HI-tACS",[65],{"type":66,"name":59,"description":61,"armGroupLabels":67,"otherNames":52},"DEVICE",[59],[69],{"name":70,"role":71,"phone":72,"phoneExt":52,"email":73},"Jiang Du, MD, PhD.","CONTACT","+8602164906315","dujiangdou@163.com",[75],{"facility":5,"status":52,"city":76,"state":52,"zip":52,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Shanghai","China","CN",{"type":80,"coordinates":81},"Point",[82,83],121.45806,31.22222,{"lat":83,"lon":82},[86],{"name":70,"role":71,"phone":87,"phoneExt":52,"email":73},"+86 021 6490 6315",{"type":89,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100610435","high-intensity-alternating-current-stimulation-as-a-neuromodulation-therapy-for-alcohol-use-disorder-a-pilot-study-100610435",false,"NCT07227545","High Intensity Alternating Current Stimulation as a Neuromodulation Therapy for Alcohol Use Disorder: A Pilot Study","HITACS-AUD","Inclusion Criteria:\n\n* Education level of junior high school or above, capable of completing questionnaires and behavioral tests;\n* Aged 18-60 years;\n* Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;\n* No abnormal findings on physical examination;\n* Agree to participate in follow-up assessments;\n* No contraindications for MRI scanning.\n\nExclusion criteria:\n\n* Have impaired intelligence (Intelligence Quotient\\\u003C70);\n* Prior tDCS or TMS treatment within the past 3 months;\n* Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);\n* Severe somatic diseases or major organ dysfunction;\n* Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).\n* Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders).\n* Diagnosis of other substance-related and addictive disorders or behavioral addictions.",true,"ALL","18 Years","60 Years",{"count":102,"type":103},18,"ESTIMATED","INTERVENTIONAL",[50],"This one-arm pilot study aims to evaluate the preliminary clinical, behavioral, and neurophysiological effects of high-intensity transcranial alternating current stimulation (HI-tACS) in individuals with alcohol use disorder (AUD). Participants will receive HI-tACS and undergo clinical and neurophysiological assessments before and after the intervention.",[108],"Alcohol Use Disorder (AUD)",[110],"High-Intensity Transcranial Alternating Current Stimulation, Alcohol Use Disorder","NOT_YET_RECRUITING","2026-09-28",{"date":114,"type":115},"2026-10-01","ACTUAL",{"date":117,"type":103},"2026-09-30",{"date":119,"type":103},"2026-12-31",{"name":5,"class":6},1]