[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":55,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":20,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"University of Sao Paulo","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"tACS Group","EXPERIMENTAL","Participants will receive 20 sessions of transcranial alternating current stimulation (tACS) over four weeks (five sessions per week). The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device, with electrodes placed at Fpz and mastoid areas.",[13],"Device: Transcranial Alternating Current Stimulation (tACS)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcranial Alternating Current Stimulation (tACS)","20 sessions of 40 minutes each, applied five times per week over four weeks, with a current of 15 mA at 77.5 Hz using the Nexalin device.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Valquíria A Silva, MD, PhD","STUDY_CHAIR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Andre R Brunoni, Professor","CONTACT","+55 (11) 2661-8159","andre.brunoni@hc.fm.usp.br",{"name":32,"role":28,"phone":29,"phoneExt":20,"email":33},"Kallene S Vidal, Professor","kallenesummer@gmail.com",[35],{"facility":36,"status":37,"city":38,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of São Paulo","RECRUITING","São Paulo","05403-010","Brazil","BR",{"type":43,"coordinates":44},"Point",[45,46],-46.63611,-23.5475,{"lat":46,"lon":45},[49,53],{"name":50,"role":28,"phone":51,"phoneExt":20,"email":52},"Valquíria Aparecida da Silva, Doctor","11973181756","valquiria.ase@gmail.com",{"name":54,"role":28,"phone":20,"phoneExt":20,"email":33},"Kallene Vidal, Doctor",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Andre R Brunoni","Professor","100625972","transcranial-alternating-current-stimulation-for-generalized-anxiety-disorder-and-insomnia-an-open-label-pilot-study-100625972",false,"NCT07429578","Transcranial Alternating Current Stimulation for Generalized Anxiety Disorder and Insomnia: An Open-Label Pilot Study","Transcranial Alternating Current Stimulation for the Treatment of Anxiety and Insomnia: An Open-Label Pilot Clinical Trial","NewWaves","Inclusion Criteria:\n\nAge between 18 and 65 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \\>5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg\u002Fday diazepam equivalent).\n\nExclusion Criteria:\n\nHistory of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).","ALL","18 Years","65 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"NA","This is an open-label pilot clinical trial to evaluate the effects of transcranial alternating current stimulation (tACS) in adults diagnosed with generalized anxiety disorder (GAD) and chronic primary insomnia. The study will involve 30 participants who will receive 20 sessions of tACS over four weeks. The stimulation will be delivered at 15 mA and 77.5 Hz using the Nexalin device. The main goal is to assess improvements in anxiety and sleep quality. Results from this study will provide preliminary evidence for future randomized controlled trials.",[78,79],"Generalized Anxiety Disorder (GAD)","Chronic Insomnia",[81,82,83,84,85,86,87],"tACS","Neuromodulation","Non-invasive brain stimulation","Sleep disorders","Anxiety treatment","Transcranial alternating current stimulation","Generalized Anxiety Disorder","2026-06-19",{"date":90,"type":91},"2026-06-23","ACTUAL",{"date":93,"type":91},"2025-06-01",{"date":95,"type":72},"2026-07-31",{"name":5,"class":6},1]