[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526001":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":46,"studyPopulation":33,"armGroups":47,"interventions":60,"overallOfficials":33,"centralContacts":69,"locations":76,"responsibleParty":96,"collaborators":33,"id":98,"slug":33,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":33,"eligibilityCriteria":102,"healthyVolunteers":99,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":33,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":79,"whyStopped":33,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Holland Bloorview Kids Rehabilitation Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":22,"otherOutcomes":33},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Recruitment","Recruitment rates of 4 participants\u002Fmonth are achieved with a ≥ 20% response rate","weeks 1-18",{"measure":14,"description":15,"timeFrame":12},"Attrition","Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).",{"measure":17,"description":18,"timeFrame":12},"Adherence","90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)",{"measure":20,"description":21,"timeFrame":12},"Blinding","Blinding of participants and their parents\u002Fcaregivers and required study team using a Blinding Questionnaire indicating the perceived group membershipmembers will be assessed using a Blinding Questionnaire indicating the perceived group membership (tDCS\u002FSham)",[23,27,30],{"measure":24,"description":25,"timeFrame":26},"Magnetic Resonance Imaging (MRI)","Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal","0 weeks, 6 weeks, 18 weeks",{"measure":28,"description":29,"timeFrame":26},"Inhibitory control","change in Go\u002FNo Task Response Time",{"measure":31,"description":32,"timeFrame":26},"Overall Clinical Change","Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","Randomized sham-controlled","TREATMENT",{"masking":40,"maskingDescription":41,"whoMasked":42},"TRIPLE","Participants and outcomes assessor will be blind to tDCS or sham condition.",[43,44,45],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Previous studies have been limited by small and poorly represented samples, lack of experimental control, insufficient follow-up periods, inadequate blinding and the absence of neural outcome measures. Our project will collect pilot data on the effects of home-based tDCS on reducing disruptive behaviours in youth with ASD, in order to inform the design of a follow-up full-scale clinical trial. We will recruit youth with ASD who experience clinically significant difficulties with social communication and self-regulation. Participants will be randomized to tDCS or sham control stimulation for 3 weeks. We will measure the effect of tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"tDCS","EXPERIMENTAL","active tDCS",[53],"Device: At-home transcranial direct current stimulation (tDCS)",{"label":55,"type":56,"description":57,"interventionNames":58},"Sham","SHAM_COMPARATOR","sham tDCS",[59],"Device: Sham at-home tDCS",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"DEVICE","At-home transcranial direct current stimulation (tDCS)","30 minutes session 5 days\u002Fweek for 3 weeks.",[49],{"type":62,"name":67,"description":64,"armGroupLabels":68,"otherNames":33},"Sham at-home tDCS",[55],[70],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},"Deryk Beal, PhD","CONTACT","416-425-6220","3582","dbeal@hollandbloorview.ca",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Holland Bloorview Kids Rehabilitation Hosptail","RECRUITING","Toronto","Ontario","M4G1R5","Canada","CA",{"type":86,"coordinates":87},"Point",[88,89],-79.39864,43.70643,{"lat":89,"lon":88},[92,93],{"name":71,"role":72,"phone":73,"phoneExt":74,"email":75},{"name":94,"role":95,"phone":33,"phoneExt":33,"email":33},"Evdokia Anagnostou, MD","SUB_INVESTIGATOR",{"type":97,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100526001",false,"NCT06129058","Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)","Inclusion Criteria:\n\n* Children with a diagnosis of autism spectrum disorder and self-regulation impairment or social communication challenges\n* Able to participate in tDCS\n\nExclusion Criteria:\n\n* Children with contraindications to tDCS (history of seizures, family history of seizures, metal implants)\n* Co-existing neurological conditions (epilepsy, stroke, etc.)","ALL","9 Years","18 Years",{"count":107,"type":108},20,"ESTIMATED","INTERVENTIONAL",[111],"PHASE2","Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that can be delivered in a home setting. It is a safe and tolerable intervention that has shown promise for improving positive social communication and self-regulation in youth with Autism Spectrum Disorder (ASD). Children and youth with ASD will be randomized to At-home tDCS or sham control stimulation for 3 weeks. We will measure the effect of At-home tDCS on the brain mechanisms and clinical measures of social communication and self-regulation..",[114],"Autism Spectrum Disorder",[49,116,117],"MRI","brain stimulation","2024-07-29",{"date":120,"type":121},"2024-07-30","ACTUAL",{"date":123,"type":121},"2023-10-20",{"date":125,"type":108},"2025-09-30",{"name":5,"class":6},1]