Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT06129058
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2023-11-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and outcomes assessor will be blind to tDCS or sham condition.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized sham-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-11-08', 'studyFirstSubmitQcDate': '2023-11-08', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment', 'timeFrame': 'weeks 1-18', 'description': 'Recruitment rates of 4 participants/month are achieved with a ≥ 20% response rate'}, {'measure': 'Attrition', 'timeFrame': 'weeks 1-18', 'description': 'Attrition rates of less than 10% (i.e., ≥90% of participants successfully complete assessments).'}, {'measure': 'Adherence', 'timeFrame': 'weeks 1-18', 'description': '90% of participants who complete assessment achieve the target intensity and dose (15 tDCS sessions)'}, {'measure': 'Blinding', 'timeFrame': 'weeks 1-18', 'description': 'Blinding of participants and their parents/caregivers 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/Sham)'}], 'secondaryOutcomes': [{'measure': 'Magnetic Resonance Imaging (MRI)', 'timeFrame': '0 weeks, 6 weeks, 18 weeks', 'description': 'Diffusion imaging - change in fractional anisotropy, Resting State functional MRI change in Blood Oxygen Level Dependent (BOLD) signal'}, {'measure': 'Inhibitory control', 'timeFrame': '0 weeks, 6 weeks, 18 weeks', 'description': 'change in Go/No Task Response Time'}, {'measure': 'Overall Clinical Change', 'timeFrame': '0 weeks, 6 weeks, 18 weeks', 'description': 'Clinical Global Impression scale - 1 item on a scale from 0-7 (a change of 0.5 indicates a clinical impact of significance)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tDCS', 'MRI', 'brain stimulation'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '40301914', 'type': 'DERIVED', 'citation': 'Abbo N, Mitchell T, Tonekaboni SH, Anagnostou E, Andrade BF, Thorpe K, Beal DS. Feasibility and usability of remote transcranial direct current stimulation (tDCS) for self-regulation in children with autism: protocol for a randomized controlled pilot study. Pilot Feasibility Stud. 2025 Apr 29;11(1):57. doi: 10.1186/s40814-025-01650-4.'}]}, 'descriptionModule': {'briefSummary': '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..', 'detailedDescription': '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..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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.)'}, 'identificationModule': {'nctId': 'NCT06129058', 'briefTitle': 'Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)', 'organization': {'class': 'OTHER', 'fullName': 'Holland Bloorview Kids Rehabilitation Hospital'}, 'officialTitle': 'Home-based Transcranial Direct Current Stimulation (tDCS) to Promote Social Communication and Behaviour in Children With Autism Spectrum Disorder (ASD)', 'orgStudyIdInfo': {'id': 'ASDR02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS', 'description': 'active tDCS', 'interventionNames': ['Device: At-home transcranial direct current stimulation (tDCS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'sham tDCS', 'interventionNames': ['Device: Sham at-home tDCS']}], 'interventions': [{'name': 'At-home transcranial direct current stimulation (tDCS)', 'type': 'DEVICE', 'description': '30 minutes session 5 days/week for 3 weeks.', 'armGroupLabels': ['tDCS']}, {'name': 'Sham at-home tDCS', 'type': 'DEVICE', 'description': '30 minutes session 5 days/week for 3 weeks.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M4G1R5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Deryk Beal, PhD', 'role': 'CONTACT', 'email': 'dbeal@hollandbloorview.ca', 'phone': '416-425-6220', 'phoneExt': '3582'}, {'name': 'Evdokia Anagnostou, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Holland Bloorview Kids Rehabilitation Hosptail', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Deryk Beal, PhD', 'role': 'CONTACT', 'email': 'dbeal@hollandbloorview.ca', 'phone': '416-425-6220', 'phoneExt': '3582'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Holland Bloorview Kids Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}