Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-24 @ 4:18 PM
Study NCT ID:
NCT06010966
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2023-07-26
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of iTBS on Children With ADHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2023-07-26', 'studyFirstSubmitQcDate': '2023-08-24', 'lastUpdatePostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ADHD-RS', 'timeFrame': '4 weeks', 'description': 'Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.'}], 'secondaryOutcomes': [{'measure': 'fMRI', 'timeFrame': '4 weeks', 'description': 'functional magnetic resonance imaging'}, {'measure': 'Stroop color-wordtask (SCWT)', 'timeFrame': '4 weeks', 'description': 'In the SCWT, the stimuli were two Chinese color words (green and red) presented in matching or contrasting font colors. The participants were asked to respond to the color of the font as quickly and as accurately as possible when a word was presented'}, {'measure': 'TMT task', 'timeFrame': '4 weeks', 'description': 'trailmaking test,TMT；It is divided into two parts: A and B. Part A requires the participants to connect 25 numbers on the paper in order (Figure 2). Part B includes 1-13 numbers and A-L12 letters, requiring participants to alternately connect these numbers and letters in orde'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ADHD', 'rTMS']}, 'descriptionModule': {'briefSummary': 'Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity . Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis, and cognitive function before and after stimulation, This study explores its therapeutic effect on attention deficit in children and adolescents with ADHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of ADHD in accordance with DSM-V;\n* Age 6-12 years old, regardless of gender\n* Right-handed\n* Han nationality or born in the Han nationality Ghetto\n* The course of the disease is greater than 6 months\n* Webster children's intelligence ≥ 70\n* The patient's guardian agrees and signs an informed consent form.\n\nExclusion Criteria:\n\n* Concomitant mental disorders such as anxiety and depression;\n* Widespread developmental disorders and other neurological developmental related disorders;\n* Complication with other important organ diseases such as heart and lungs;\n* Suffering from diseases such as epilepsy and tic disorder;\n* Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment.\n* Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been systematic use of first-line ADHD drugs in clinical practice Webster's intelligence\\<70\n* Implantation of metal and electronic components in the body (excluding the oral cavity), such as pacemakers;"}, 'identificationModule': {'nctId': 'NCT06010966', 'briefTitle': 'Effect of iTBS on Children With ADHD', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Zhejiang University'}, 'officialTitle': 'Effect of Intermittent TBS on Children With ADHD', 'orgStudyIdInfo': {'id': 'IIT20220110C-R2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'sham group', 'description': 'receive sham itbs', 'interventionNames': ['Device: rTMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'low-dose group', 'description': 'receive low dose of itbs', 'interventionNames': ['Device: rTMS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high-dose group', 'description': 'receive high dose of itbs', 'interventionNames': ['Device: rTMS']}], 'interventions': [{'name': 'rTMS', 'type': 'DEVICE', 'description': 'intermittent theta-burst stimulation (iTBS)', 'armGroupLabels': ['high-dose group', 'low-dose group', 'sham group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hu ShaoHua', 'role': 'CONTACT', 'email': 'dorhushaohua@zju.edu.cn', 'phone': '13957162903'}], 'facility': 'Department of Psychiatry, First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Shaohua Hu, Dr', 'role': 'CONTACT', 'email': 'dorhushaohua@zju.edu.cn', 'phone': '0571-87235987'}], 'overallOfficials': [{'name': 'Shaohua Hu, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual participant data (IPD) is aviliable from Principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Hu ShaoHua', 'investigatorAffiliation': 'First Affiliated Hospital of Zhejiang University'}}}}