Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2025-12-27 @ 9:54 PM
Study NCT ID:
NCT05578261
Status:
UNKNOWN
Last Update Posted:
2023-08-31
First Post:
2022-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-06-13', 'releaseDate': '2025-06-01'}], 'estimatedResultsFirstSubmitDate': '2025-06-01'}}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2022-10-11', 'studyFirstSubmitQcDate': '2022-10-12', 'lastUpdatePostDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse effects report form (Headache)', 'timeFrame': '1 week after iTBS (post iTBS)', 'description': 'Recording adverse effects in participants after iTBS.'}, {'measure': 'Adverse effects report form (Dizziness)', 'timeFrame': '1 week after iTBS (post iTBS)', 'description': 'Recording adverse effects in participants after iTBS.'}, {'measure': 'Adverse effects report form (Tinnitus)', 'timeFrame': '1 week after iTBS (post iTBS)', 'description': 'Recording adverse effects in participants after iTBS.'}, {'measure': 'Adverse effects report form (Seizure)', 'timeFrame': '1 week after iTBS (post iTBS)', 'description': 'Recording adverse effects in participants after iTBS.'}, {'measure': 'Adverse effects report form (Other)', 'timeFrame': '1 week after iTBS (post iTBS)', 'description': 'Recording adverse effects in participants after iTBS.'}], 'secondaryOutcomes': [{'measure': 'MRI T1', 'timeFrame': 'Within one month', 'description': 'Brain structural volumes (cm²)'}, {'measure': 'functional MRI (resting-state/biological motion task) - BOLD signal', 'timeFrame': 'Within one month', 'description': 'Blood-oxygen-level-dependent (BOLD) signal is a measurement used in fMRI, which reflects the neural activity.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder']}, 'descriptionModule': {'briefSummary': 'The investigator would like to investigate the impact of theta-burst stimulation over cerebellum in adults with autism spectrum disorder'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with autism spectrum disorder (≥18 years old), confirmed by Autism Diagnostic Observation Schedule.\n\nExclusion Criteria:\n\n* Previous or current severe neurological disorder such as epilepsy, visual or hearing impairment.\n* Previous or current severe systemic disease such as cardiovascular disease, diabetes or infection.\n* Previous or current severe brain injury\n* Implementation of metal materials such as pacemaker or medication pump\n* Previous or current severe psychiatric disorders such as schizophrenia, bipolar disorder or substance abuse\n* Pregnancy\n* Individuals with a significant brain abnormality such as intracranial space occupied lesions\n* History of brain surgery or nervous system infection, such as meningitis and encephalitis\n* Concurrent use of medications which increased the risk of seizure attack\n* Participate another clinical trial within one month\n* Skin trauma on application site\n* Individuals suffering from multiple sclerosis\n* Individuals with a large ischemic scar\n* Individuals suffering from sleep deprivation during rTMS procedures\n* Individuals with a heavy consumption of alcohol\n* Current taking antiepileptic drugs\n* Individuals with a migraine headache from increased intracranial pressure\n* Unable to complete MRI scan\n\nWithdrawal criteria:\n\n* Seizure attack during study period\n* Autistic symptoms worsened obviously during study period\n* Extreme agitation or irritability during study period\n* Participants request\n* Take antiepileptic drug during study period'}, 'identificationModule': {'nctId': 'NCT05578261', 'briefTitle': 'Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder', 'orgStudyIdInfo': {'id': '202200409A0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'All of the participants will accept one session iTBS over right Crus I/II. The total pulses of every session are 1200 pulses (600 pulses with 15 minutes interval)\n\n\\*iTBS = intermittent theta burst stimulation.', 'interventionNames': ['Device: intermittent theta burst stimulation']}], 'interventions': [{'name': 'intermittent theta burst stimulation', 'type': 'DEVICE', 'description': 'stimulatory protocol', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-06-01', 'type': 'RELEASE'}, {'date': '2025-06-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Chang Gung Memorial Hospital'}}}}