[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554056":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":34,"studyPopulation":23,"armGroups":35,"interventions":54,"overallOfficials":23,"centralContacts":68,"locations":78,"responsibleParty":98,"collaborators":102,"id":106,"slug":23,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":23,"eligibilityCriteria":111,"healthyVolunteers":107,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":23,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":23,"overallStatus":81,"whyStopped":23,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"All India Institute of Medical Sciences, Bhubaneswar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Positive and Negative Syndrome Scale (PANSS)","Measures psychopathology and illness severity in schizophrenia","Baseline, Day 5, Day 10",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Auditory Hallucination Rating Scale (AHRS)","Measures severity of auditory hallucinations in schizophrenia",{"measure":18,"description":19,"timeFrame":12},"Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)","Measures neurocognitive deficits in schizophrenia",{"measure":21,"description":22,"timeFrame":12},"Global Assessment of Functioning (GAF)","Measures overall functioning of the patients with mental illness including schizophrenia",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"RANDOMIZED","PARALLEL","The intervention arms are Experimental (tACS), Active comparator (tDCS) and control comparator (sham). The patients in all 3 arms will continue to receive the ongoing antipsychotics.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":31},"DOUBLE",[32,33],"PARTICIPANT","OUTCOMES_ASSESSOR","The proposed double-blind RCT will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. Those with any psychiatric emergency or contraindications for tDCS will be excluded. At baseline, PANSS will be administered to assess the severity of symptom dimension, AHRS for auditory hallucinations, B-CATS for neurocognitive deficits and GAF for global functionality. Patients will be randomized equally to 3 treatment groups: tACS, tDCS, or sham stimulation (30 in each group). The intervention will involve Cathodal stimulation of left TPJ and Anodal stimulation of left DLPFC. The transcranial brain stimulations: tACS, tDCS, or sham stimulation, will be given 2 sessions per day for 10 days. Following the 5th day and after the last treatment session, PANSS, AHRS, B-CATS, and GAF will be readministered to observe for the changes in the various outcome parameters. Any new treatment-emergent serious adverse effect will be recorded.",[36,42,48],{"label":37,"type":38,"description":39,"interventionNames":40},"tACS group","EXPERIMENTAL","10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current",[41],"Device: transcranial Alternating current stimulation (tACS)",{"label":43,"type":44,"description":45,"interventionNames":46},"tDCS group","ACTIVE_COMPARATOR","tDCS stimulation: 2 mA stimulation will be applied for 20 minutes",[47],"Device: transcranial Direct current stimulation (tDCS)",{"label":49,"type":50,"description":51,"interventionNames":52},"sham controlled group","SHAM_COMPARATOR","1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects",[53],"Device: Sham controlled",[55,60,64],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":23},"DEVICE","transcranial Alternating current stimulation (tACS)","It is a non-invasive brain stimulation technique that uses small, pulsed alternating current (1mA) to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.",[37],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":23},"transcranial Direct current stimulation (tDCS)","It is a non-invasive brain stimulation technique that uses constant, low direct current to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.",[43],{"type":56,"name":65,"description":66,"armGroupLabels":67,"otherNames":23},"Sham controlled","1mA current will be applied for the first 30 seconds to provide the initial sensation of real stimulation, and then the current will be stopped, thus minimizing the stimulatory effects. It is known to have no effect on psychopathology\u002Fneuro-cognition and means to mimic the tDCS\u002FtACS (in order to help blinding of the participants).",[49],[69,74],{"name":70,"role":71,"phone":72,"phoneExt":23,"email":73},"Biswa R Mishra","CONTACT","09438884220","brm1678@gmail.com",{"name":75,"role":71,"phone":76,"phoneExt":23,"email":77},"Debadatta Mohapatra","09438884221","psych_debadatta@aiimsbhubaneswar.edu.in",[79],{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"All India Institute of Medical Scinces - Bhubaneswar","RECRUITING","Bhubaneswar","Odisha","751019","India","IN",{"type":88,"coordinates":89},"Point",[90,91],85.83385,20.27241,{"lat":91,"lon":90},[94,96],{"name":95,"role":71,"phone":72,"phoneExt":23,"email":73},"Biswa R Mishra, MD, DPM",{"name":97,"role":71,"phone":76,"phoneExt":23,"email":77},"Debadatta Mohapatra, MD",{"type":99,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","BISWA RANJAN MISHRA","Additional Professor",[103],{"name":104,"class":105},"Indian Council of Medical Research","OTHER_GOV","100554056",false,"NCT06494124","Efficacy and Safety of tACS vs tDCS in Schizophrenia","Comparison of Efficacy and Safety of Transcranial Alternating Current Stimulation vs Transcranial Direct Current Stimulation on Psychopathology Measures and Neurocognition in Chronic Schizophrenia: A Randomized Double-blind Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years\n2. Moderate-severe symptoms (PANSS score \\> 75 and\u002For CGI-SCH score\\>4) \\[24\\]\n3. On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)\n4. Both sexes; Age range: 18-60 years\n5. Right-handed\n6. Written informed consent by the patient\n\nExclusion Criteria:\n\n1. Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)\n2. Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp \u002F head\n3. Co-morbid neurological disease\n4. Left Handed","ALL","18 Years","60 Years",{"count":116,"type":117},90,"ESTIMATED","INTERVENTIONAL",[120],"NA","This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.\n\nThe main question it aims to answer is:\n\n• In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?\n\nParticipants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).",[123],"Schizophrenia","2024-07-08",{"date":126,"type":127},"2024-07-10","ACTUAL",{"date":129,"type":127},"2024-04-03",{"date":131,"type":117},"2026-06",{"name":5,"class":6},1]