Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT06127056
Status:
UNKNOWN
Last Update Posted:
2023-11-14
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-12', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2023-11-07', 'lastUpdatePostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the number, frequency, and impulsivity of self-injurious behaviors', 'timeFrame': 'baseline and immediately after the intervention', 'description': 'Adolescent Non-suicidal self-injury Assessment Questionnaire consisted of 2 dimensions and 12 items, with 5 options for each item, namely, "none, occasional, sometimes, often, and always", and was scored on a 5-point Likert scale from 0 to 4. The score for each item was summed up as the total score of the questionnaire, and the total mean score was divided by the number of items. The total mean score was divided by the number of items, and the higher the total mean score, the more serious the patients\' non-suicidal Likert 5 self-injurious behaviors were.'}], 'secondaryOutcomes': [{'measure': 'Change in Hamilton Depression Rating Scale (HAMD) Score', 'timeFrame': 'baseline and immediately after the intervention', 'description': 'The HAMD is a clinician-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.'}, {'measure': 'Change in Hamilton Anxiety Scale (HAMA) Score', 'timeFrame': 'baseline and immediately after the intervention', 'description': 'The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.'}, {'measure': 'Change in Patient Health Questionnaire-15 (PHQ-15) Score', 'timeFrame': 'baseline and immediately after the intervention', 'description': 'The PHQ-15 is a 15-item scale to measure the severity of somatic symptoms, where each item is rated on a scale from 0 to 2. The PHQ-15 total score ranges from 0 to 30, with lower scores indicating less somatic symptoms.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transcranial Alternating Current Stimulation', 'Non-suicidal Self-injury']}, 'descriptionModule': {'briefSummary': 'To investigate the intervention effect of high-definition transcranial alternating current stimulation (HD-tACS) on patients with Non-suicidal Self-injury (NSSI) and its underlying neural mechanism by magnetic resonance imaging (MRI).', 'detailedDescription': 'Forty patients with Non-suicidal Self-injury (NSSI) diagnosed by DSM-5 were recruited from the Second Affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving high-definition transcranial alternating current stimulation (HD-tACS) treatment after meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, magnetic resonance imaging (MRI), and HD-tACS treatment conducted by trained researchers at the Second Affiliated Hospital of Anhui Medical University. All the participants were randomized (1:1) to receive an "active HD-tACS" or "sham HD-tACS" treatment protocol. tACS: the central electrode was placed over F3 with return electrodes placed at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as individual alpha frequency (IAF). Sham HD-tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 15 and 15 seconds.\n\nBefore and after the treatments, the patients received a battery measure of neuropsychological tests, and MRI scans in multimodalities. The neuropsychological assessment included the Ottawa Self-injury Inventory (OSI), the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ), the Hamilton Depression Rating Scale (HAMD), the Hamilton Anxiety Rating Scale (HAMA), and Patient Health Questionnaire-15 (PHQ-15) etc.Multimodal MRI includes 3D-T1, rs-fMRI, and DTI. The symptoms of the patients were followed up one and two months after the end of treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months.\n\n12-18 years of age.\n\nThe medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level.\n\nExclusion Criteria:\n\nThe patient has suicidal ideation or has committed suicidal behavior\n\nT1 or T2 weighted phase magnetic resonance images show focal brain lesions\n\npatients had neurological disorders such as epilepsy, or serious physical illnesses\n\npatients had a history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months\n\npatients had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months or received electroconvulsive therapy in the last 6 months\n\npatients had previous significant head trauma or EEG abnormality in the last 1 month\n\nbody-mounted devices unsuitable for treatment, such as pacemakers, artificial valves, and other metal implants.'}, 'identificationModule': {'nctId': 'NCT06127056', 'briefTitle': 'Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)', 'organization': {'class': 'OTHER', 'fullName': 'Anhui Medical University'}, 'officialTitle': 'Intervention Effect of High-Definition Transcranial Alternating Current Stimulation (HD-tACS) on Non-suicidal Self-injury (NSSI)', 'orgStudyIdInfo': {'id': 'AHMU-tACS-NSSI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'real stimulation', 'description': 'The central electrode was placed over F3, with return electrodes at Fp1, Fz, F7 and C3. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 15 and 15 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as IAF.', 'interventionNames': ['Device: High-Definition Transcranial Alternating Current Stimulation (HD-tACS)']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham stimulation', 'description': 'In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15 and 15 s); no current was delivered during the 20-minute intervention. Participants will receive sham tACS twice daily for two weeks.', 'interventionNames': ['Device: sham High-Definition Transcranial Alternating Current Stimulation (HD-tACS)']}], 'interventions': [{'name': 'High-Definition Transcranial Alternating Current Stimulation (HD-tACS)', 'type': 'DEVICE', 'description': 'tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.', 'armGroupLabels': ['real stimulation']}, {'name': 'sham High-Definition Transcranial Alternating Current Stimulation (HD-tACS)', 'type': 'DEVICE', 'description': 'In the sham condition, tACS was delivered only during the ramp-up and ramp-down periods (15s and 15s); no current was delivered during the 20-minute intervention.', 'armGroupLabels': ['sham stimulation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kai Wang, PhD', 'role': 'CONTACT', 'email': 'wangkai1964@126.com', 'phone': '+86-0551-62923704'}, {'name': 'Yanghua Tian, PhD', 'role': 'CONTACT', 'email': 'ayfytyh@126.com', 'phone': '+8613955188448'}], 'facility': 'Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}], 'centralContacts': [{'name': 'Kai Wang, PhD', 'role': 'CONTACT', 'email': 'wangkai1964@126.com', 'phone': '+86-0551-62923704'}, {'name': 'Yanghua Tian, PhD', 'role': 'CONTACT', 'email': 'ayfytyh@126.com', 'phone': '+8613955188448'}], 'overallOfficials': [{'name': 'Yanghua Tian, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Anhui Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anhui Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC', 'investigatorFullName': 'WANG KAI', 'investigatorAffiliation': 'Anhui Medical University'}}}}