Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT05491720
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2022-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018967', 'term': 'Risperidone'}, {'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2023-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gilliam Autism Rating Scale (GADS)', 'timeFrame': 'up to 3 months after the intervention', 'description': 'Score in the Gilliam Autism Rating Scale (GADS)\n\nAutism index scores:\n\n69 or less = unlikely 70-84 = possible 85 or higher = very likely'}, {'measure': 'verbal fluency task', 'timeFrame': 'up to 3 months after the intervention', 'description': 'Performance in the verbal fluency task as an executive and language function task'}, {'measure': 'Theory of mind', 'timeFrame': 'up to 3 months after the intervention', 'description': 'Score in the Theory of Mind Test (ToMT) Score range of subscales 1 to 3, is 0-20, 0-13, and 0-5, respectively and the total score range is 0-38.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder', 'detailedDescription': '45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist\n* being 6-16 years old\n* providing written informed consent signed by parents\n\nExclusion Criteria:\n\n* comorbidity with other neurodevelopmental disorders\n* comorbidity with other neurological disorders\n* previous history of neurosurgery\n* presence of any ferromagnetic metal in the head\n* implanted medical devices in the head or neck region\n* history of noncontrolled epilepsy with seizures in the last year'}, 'identificationModule': {'nctId': 'NCT05491720', 'briefTitle': 'Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'The National Brain Mapping Laboratory (NBML)'}, 'officialTitle': 'Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': 'IR.ARUMS.REC.1395.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS group', 'description': 'TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the left dorsolateral prefrontal cortex and cathodal electrode will be placed over the right supraorbital area.', 'interventionNames': ['Device: transcranial direct current stimulation', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Medication group', 'description': 'Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days', 'interventionNames': ['Drug: RisperiDONE 1 MG/ML', 'Device: sham transcranial direct current stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.', 'interventionNames': ['Drug: Placebo', 'Device: sham transcranial direct current stimulation']}], 'interventions': [{'name': 'RisperiDONE 1 MG/ML', 'type': 'DRUG', 'description': 'Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days', 'armGroupLabels': ['Medication group']}, {'name': 'transcranial direct current stimulation', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days', 'armGroupLabels': ['tDCS group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will receive placebo tablet (Galenus pharmaceutical company)', 'armGroupLabels': ['Control group', 'tDCS group']}, {'name': 'sham transcranial direct current stimulation', 'type': 'DEVICE', 'description': 'Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days', 'armGroupLabels': ['Control group', 'Medication group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'The National Brain Mapping Laboratory (NBML)', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The National Brain Mapping Laboratory (NBML)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ardabil University of Medical Sciences', 'class': 'OTHER'}, {'name': 'Leibniz Research Centre for Working Environment and Human Factors', 'class': 'OTHER'}, {'name': 'University of Tehran', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohammad Ali Salehinejad', 'investigatorAffiliation': 'The National Brain Mapping Laboratory (NBML)'}}}}