Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-30 @ 7:05 AM
Study NCT ID:
NCT06195995
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2023-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005715', 'term': 'Gambling'}], 'ancestors': [{'id': 'D012309', 'term': 'Risk-Taking'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct 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': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2023-12-24', 'studyFirstSubmitQcDate': '2023-12-24', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The change of depression', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Depression will be measured by the Patient Health Questionnaire-9(PHQ-9). The total score of PHQ-9 ranged from 0 to 27, in which higher scores mean a higher level of depression.'}, {'measure': 'The change of anxiety', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Anxiety will be measured by the questionnaire of Generalized Anxiety Disorder(GAD-7). The total score of GAD-7 ranged from 0 to 21, in which higher scores mean a higher level of anxiety.'}, {'measure': 'The change of sleep', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) rated by both patients and observers. The total score of PSQI ranged from 0 to 21, in which higher scores mean a lower level of sleep quality.'}], 'primaryOutcomes': [{'measure': 'The change of gambling behavior', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Questions including monetary loss, time, frequency and interval of gambling will be answered by patients to quantify their gambling behavior.'}, {'measure': 'The change of gambling craving', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Gambling craving will be measured by the gambling craving Visual Analog Scale (VAS). The total score of VAS ranged from 0 to 10, in which higher scores mean a higher level of gambling craving.'}, {'measure': 'The change of gambling symptom', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Gambling symptom will be measured by the Gambling Symptom Assessment Scale (G-SAS). The total score of G-SAS ranged from 0 to 48, in which higher scores mean a higher level of gambling symptom.'}, {'measure': 'The change of pathological gambling', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'Pathological gambling will be measured by the Yale-Brown Obsessive Compulsive Scale adapted for Pathological Gambling (PG-YBOCS). The total score of PG-YBOCS ranged from 0 to 40, in which higher scores mean a higher level of pathological gambling.'}], 'secondaryOutcomes': [{'measure': 'The change of self-control', 'timeFrame': 'baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention', 'description': 'The change of self-control will be measured by the stop-signal task and balloon analog risk-taking task.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transcutaneous Electric Nerve Stimulation', 'Gambling']}, 'descriptionModule': {'briefSummary': "The investigators assume that transcranial Alternating Current Stimulation (tACS) could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism.", 'detailedDescription': "Gambling disorder is become a major social and public health problem in China. Executive-control dysfunction is the main symptom of behavioral addiction like gambling disorder. Previous studies have demonstrated the relationship between cognitive dysfunction and prefrontal-ventral striatum pathway. Studies have shown that abnormal phase synchronization and phase-amplitude coupling (PAC) induced the impairment of cognition, and transcranial Alternating Current Stimulation (tACS) could improve executive-control function by adjusting the abnormal synchronization. However, it has not been verified among gambling disorder patients. The investigators assume that tACS could improve gambling disorder patients' executive-control function by adjusting the synchronization patterns and enhancing the functional connectivity of the prefrontal-ventral striatum pathway. This study intends to test the effect of tACS treatment. Three-month follow-up assessment will be conducted to test the changing of the executive-control function and its mechanism. This study will provide a practical and theoretical basis for developing a novel treatment for gambling disorder."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-60, male or female, with 9 or more years of education, and able to complete questionnaire evaluation and behavioral tests\n* Meet DSM-5 (Diagnostic and Statistical Manual of mental disorders，DSM) diagnostic criteria for gambling disorder\n* Have gambled for at least one year (at least once a week)\n* Normal vision and hearing, or within the normal range after correction\n* Agree to cooperate in the follow-up evaluation\n* No metal implantation in the head, no history of nerve problems or head injury, and no skin sensitivity\n\nExclusion Criteria:\n\n* Have severe cognitive impairment, such as a history of head trauma, cerebrovascular disease, epilepsy, etc.\n* Have used drugs promoting cognitive function in the last 6 months\n* Have impaired intelligence (Intelligence Quotient\\<70)\n* Abuse or dependence of psychoactive substances (except nicotine) in the last 5 years'}, 'identificationModule': {'nctId': 'NCT06195995', 'briefTitle': 'Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Brain Mechanism and Intervention of Executive-control Dysfunction Among Gambling Disorder', 'orgStudyIdInfo': {'id': 'JDu-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group for gambling addiction', 'description': 'A 40-minute transcranial alternating current stimulus intervention of real stimulus is conducted twice a day (at least 3 hours apart) for a total of 10 days in the intervention group of gambling addiction.', 'interventionNames': ['Device: Transcranial alternating current stimulation-true stimulus']}], 'interventions': [{'name': 'Transcranial alternating current stimulation-true stimulus', 'type': 'DEVICE', 'description': 'Three conductive electrodes are placed overhead. In the 10/20 international placement system, a 4.45 9.53 cm electrode is placed on the forehead corresponding to Fpz, Fp1 and Fp2. Two 3.18 3.81 cm electrodes are placed on the mastoid region of each side. The tACS stimulation waveform includes ramp-up and ramp-down periods of 180 and 12 s, respectively. The frequency of stimulation is 77.5Hz, and the current is 15mA.', 'armGroupLabels': ['Intervention group for gambling addiction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang Du, MD, PhD', 'role': 'CONTACT', 'email': 'dujiangdou@163.com', 'phone': '+86 021 6490 6315'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jiang Du, MD, PhD', 'role': 'CONTACT', 'email': 'dujiangdou@163.com', 'phone': '+862164906315'}], 'overallOfficials': [{'name': 'Jiang Du, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}