Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06208358
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for the Disrupted Interpersonal Interaction Among Gaming Disorder Individuals and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cue-induced craving', 'timeFrame': 'Two weeks,Four weeks', 'description': 'Craving was assessed by visual analog scales (VAS), with 0 mm being "no craving"and 100 mm representing "most craving ever experienced for gaming ".'}, {'measure': 'inter-brain synchronization (IBS)', 'timeFrame': 'Two weeks,Four weeks', 'description': 'IBS was assessed by fNIRS hyperscanning with WTC analysis. A higher WTC refers to a higher level of inter-brain synchronization.'}, {'measure': 'cognition measures', 'timeFrame': 'Four weeks', 'description': 'Chinese version of the CogState Battery was used to assess cognitive function. We selected five tasks: Two back task (working memory), Continuous paired association task (visual spatial working memory), Groton maze learning task (error monitoring), social emotional cognition (social emotional cognition) and Detection task (processing speed) which were displayed on a green screen with standardized instructions before each task beginning.The accuracy in Two back task, social emotional cognition, and the speed in Detection task, and total errors in Continuous paired association task, Groton maze learning task are our focus.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gaming Disorder']}, 'descriptionModule': {'briefSummary': 'Aiming at the major problems of unclear brain mechanism of gaming disorder and lack of effective assessment intervention tools, this project started by exploring the brain mechanism of abnormal interpersonal interaction and cognitive control deficit promoting and accelerating the development of gaming disorder, adopted a prospective cohort study design, combined with multi-modal brain functional imaging, cognitive function, social psychological assessment, and other means. To clarify the brain mechanism and outcome of gaming disorder. Based on the preliminary stage, for high-risk groups, risky gaming behavior, gaming disorder layout hierarchical multidimensional assessment intervention system, using science education, brief intervention, social psychological intervention, neural regulation, cognitive rehabilitation training, mobile medical treatment, and other ways, stratification and stage, early identification, prevention and treatment combination, accurate intervention to comprehensively reduce the occurrence and development of gaming disorder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1)Clinical diagnosis of severe Gaming Disorder defined in the ICD-11; (2)Normal hearing and vision, or within normal range after correction;\n\nExclusion Criteria:\n\n* (1) Clinical diagnosis of mental health disorders other than GD defined in the ICD-11 in the past 5 years；(2) Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; (3) Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria;(4)any contraindication for tACS intervention.'}, 'identificationModule': {'nctId': 'NCT06208358', 'briefTitle': 'A Study for the Disrupted Interpersonal Interaction Among Gaming Disorder Individuals and Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Brain Mechanism of Disrupted Interpersonal Interaction in Gaming Disorder Affecting Cognitive Control and Its Hierarchical Multidimensional Evaluation Intervention', 'orgStudyIdInfo': {'id': 'NZhong-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'real tACS', 'description': 'Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory', 'interventionNames': ['Device: tACS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tACS', 'description': 'Device: Transcranial Alternating Current Stimulation In recent years, transcranial alternating current stimulation (tACS) has been widely used to regulate brain neural activity and improve cognitive function because of its non-invasive, portable, and easy-to-operate characteristics. tACS can effectively improve 9 cognitive functions, including visual attention, working memory, long-term memory, executive control, fluid intelligence, learning, decision-making, motor learning, and motor memory', 'interventionNames': ['Device: tACS']}], 'interventions': [{'name': 'tACS', 'type': 'DEVICE', 'description': 'We aim to use tACS devices to improve the disrupted interpersonal interaction among gaming disorder individuals.', 'armGroupLabels': ['real tACS', 'sham tACS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Na Zhong, MD', 'role': 'CONTACT', 'email': 'winco917@hotmail.com', 'phone': '008613671644472'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}