[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607199":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":24,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":24,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":24,"overallStatus":71,"whyStopped":24,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tACS","EXPERIMENTAL","Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to their ongoing stable pharmacotherapy. tACS will be delivered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with a frequency of 77.5 Hz and current intensity of 15 mA. One electrode is placed on the forehead and two electrodes on the mastoid processes. Each session lasts approximately 40 minutes, with a total of 20 sessions administered over 4 weeks (5 sessions per week). The intervention aims to modulate cortical activity and improve depressive symptoms, cognitive function, and emotional regulation.",[13],"Device: tACS",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham","SHAM_COMPARATOR","Participants in this group will receive sham stimulation in addition to their ongoing stable pharmacotherapy. A sham device identical in appearance, sound, and operation to the active tACS device will be used but will not deliver any electrical current. Treatment is administered in the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators are blinded to the treatment assignment to ensure study integrity.",[13],[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","This intervention uses the NEXALIN ADI alternating current stimulation device from Beijing Naisilin Technology Co., Ltd., to deliver targeted stimulation to the prefrontal cortex and bilateral mastoid regions. The prefrontal cortex electrode directly stimulates the cerebral cortex, while the mastoid electrodes ensure the synchronized activation of bilateral neural pathways. Stimulation is applied at a frequency of 77.5 Hz and a current intensity of 15 mA, aiming to optimize brainwave synchronization and modulate brain activity.\n\nParticipants will undergo daily sessions lasting approximately 40 minutes each, for a total of 20 sessions over 4 weeks. The non-invasive nature of the intervention, combined with its precise targeting of specific brain regions, distinguishes it from other neuromodulation therapies. The treatment aims to enhance neural synchronization, promote neuroplasticity, and provide a non-pharmacological therapeutic alternative for patients.",[9],null,{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"In the sham stimulation group, participants will receive intervention using a sham device that is identical in appearance, operation, and stimulation protocol to the real tACS device, but does not deliver any current. Both participants and operators will be unable to distinguish between real and sham stimulation based on the device's appearance, sound, or tactile feedback. Device allocation will follow a randomized code generated in advance to ensure blinding and proper group assignment.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Xinyu Zhou","CONTACT","15823996993","zhouxinyu@cqmu.edu.cn",[35],{"facility":36,"status":24,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"The First Affiliated Hospital of Chongqing Medical University","Chongqing","Chongqing Municipality","40000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],106.55771,29.56026,{"lat":46,"lon":45},[49],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},{"type":51,"investigatorFullName":30,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","professor","100607199","efficacy-and-safety-of-transcranial-alternating-current-stimulation-tacs-combined-with-stable-medication-in-adolescents-with-depression-a-randomized-double-blind-controlled-pilot-study-100607199",false,"NCT07185451","Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study","Inclusion Criteria:\n\n1. Age 12-18 years.\n2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.\n3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.\n4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.\n\nExclusion Criteria:\n\n1. Psychiatric comorbidities other than anxiety disorders.\n2. Depression with psychotic features.\n3. Young Mania Rating Scale (YMRS) score \\>13.\n4. History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).\n5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.\n6. Current use of antiepileptic drugs or high-dose benzodiazepines.\n7. History of alcohol or substance abuse or dependence.\n8. Pregnant or breastfeeding females.\n9. Contraindications to MRI.\n10. Current high suicide risk.","ALL","12 Years","18 Years",{"count":63,"type":64},30,"ESTIMATED","INTERVENTIONAL",[67],"NA","To evaluate the efficacy of tACS treatment. To determine whether tACS can accelerate symptom remission, improve clinical response rates, and facilitate the recovery of emotional and cognitive functions through standardized clinical assessments.\n\nTo evaluate the safety of tACS treatment. To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.",[70],"Depression - Major Depressive Disorder","NOT_YET_RECRUITING","2025-09-15",{"date":74,"type":75},"2025-09-22","ACTUAL",{"date":77,"type":64},"2025-10-01",{"date":79,"type":64},"2026-10-01",{"name":5,"class":6},1]