[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565700":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":31,"locations":40,"responsibleParty":60,"collaborators":62,"id":65,"slug":31,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":31,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":31,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":43,"whyStopped":31,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Bambino Gesù Hospital and Research Institute","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm Pre-SMA","ACTIVE_COMPARATOR","Active cathodal HD-tDCS over pre-SMA cortex. For HD-tDCS a 4 × 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over Fz with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up\u002Fdown).\n\nFor the electrodes' placement, the investigators will follow the recommended guidelines for children.",[13],"Device: Active HD-tDCS over pre-SMA",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm left-dlPFC","Active cathodal HD-tDCS over left dlPFC cortex. For HD-tDCS a 4 × 1 montage, small circular electrodes (diameter 1 cm) will be used with the cathode placed centrally over F3 with a current intensity of 0.5 mA for a total of 20 minutes (30 s ramp up\u002Fdown).\n\nFor the electrodes' placement, the investigators will follow the recommended guidelines for children.",[18],"Device: Active HD-tDCS over left DLPFC",{"label":20,"type":21,"description":22,"interventionNames":23},"Arm Sham","SHAM_COMPARATOR","Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex. The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness.",[24],"Device: Sham HD-tDCS",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Active HD-tDCS over pre-SMA","Active cathodal HD-tDCS over pre-SMA cortex will be delivered for 10 days (3 sessions per week). The 4 × 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over Fz. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up\u002Fdown).",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Active HD-tDCS over left DLPFC","Active cathodal HD-tDCS over left DLPFC cortex will be delivered for 10 days (3 sessions per week). The 4 × 1 montage using small circular electrodes (diameter 1 cm) will be applied with the cathode placed centrally over F3. The current intensity will be set at 0.5 mA for a total of 20 minutes (30 s ramp up\u002Fdown).",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Sham HD-tDCS","Sham HD-tDCS will be delivered over pre-SMA or left-dlPFC cortex for 10 days (3 sessions per week). The same electrodes placement as well as the stimulation set-up will be used as in the active stimulation conditions, but the current will be applied for 30 s and will be ramped down (0 mA) during the rest of the session without the participants awareness. Each Sham session will last 20 minutes.",[20],[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":45,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Bambino Gesù Children Hospital","RECRUITING","Rome","Italy","00152","IT",{"type":49,"coordinates":50},"Point",[51,52],12.51133,41.89193,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":58,"phoneExt":31,"email":59},"Chiara Mennini","CONTACT","+390668592572","chiara.mennini@opbg.net",{"type":61,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[63],{"name":64,"class":6},"Ministero della Salute, Italy","100565700",false,"NCT06645587","Targeting Repetitive Behaviors in Autism Spectrum Disorder Via Transcranial Direct Current Stimulation","Understanding and Targeting Repetitive Behaviors and Restricted Interests in Autism Spectrum Disorder Via High-Definition Transcranial Direct Current Stimulation","Inclusion Criteria:\n\n* participants of both genders with ASD diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and based on clinical evaluation and administration of gold standard tools for ASD diagnosis\n* an intelligence quotient (IQ) higher or equal to 70 (IQ ≥ 70)\n* age range from 8 years to 13 years and 11 months included\n\nExclusion Criteria:\n\n* the presence of neurological\u002Fmedical\u002Fgenetic conditions (i.e., brain tumours or genetic syndromes)\n* personal or family history of epilepsy\n* other primary psychiatric diagnoses (i.e., bipolar disorders, schizophrenia spectrum disorders, or adjustment disorder)\n* sensorimotor deficits\n* the presence of peacemaker or other metal devices in the body;\n* ongoing CNS-active drug treatment\n* receiving other cognitive-behavioral therapies specifically focused on RBs in the 3 months before the study","ALL","8 Years","13 Years",{"count":75,"type":76},78,"ESTIMATED","INTERVENTIONAL",[79],"NA","Repetitive behaviors (RBs) are a prevalent feature of Autism Spectrum Disorder (ASD). There are two groups of RBs: lower-order (e.g. motor stereotypies) and higher-order RBs (e.g. restricted interests), linked to sensory-motor and the associative loops, respectively. To date, treatment options for RBs are very limited. High-definition transcranial direct current stimulation (HD-tDCS) may be effective in reducing the impact of RBs in children with ASD by targeting the associated brain alterations. Moreover, the high focality of HD-tDCS will help the investigators to disentangle the relative contribution of different brain loops (namely, sensory-motor and the associative loops) into RBs subtypes. The investigators will also study the electrophysiological patterns associated to behavioral changes after the application of HD-tDCS.",[82],"Autism Spectrum Disorder",[82,84,85,86,87,88],"HD-tDCS","Restricted Interests","Repetitive Behaviors","Neurodevelopmental Disorders","transcranial direct current stimulation","2024-10-15",{"date":91,"type":92},"2024-10-17","ACTUAL",{"date":94,"type":92},"2024-10-03",{"date":96,"type":76},"2026-04",{"name":5,"class":6},1]