Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-01-01 @ 6:49 AM
Study NCT ID:
NCT06919432
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Triple-daily 15mA tACS on Adolescent 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both clinical staff and participants were blinded to the assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present clinical protocol is designed as a double-blind, parallel, sham-controlled, randomized clinical trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-04-02', 'studyFirstSubmitQcDate': '2025-04-02', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total NSSI incidents during the 4-week follow-up period post-intervention', 'timeFrame': '6 weeks', 'description': 'It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The primary outcome is the proportion of participants achieving a ≥50% decrease in NSSI frequency within the past month at Day 42, as measured by the SITBI-R. A threshold of 50% reduction was selected based on its clinical relevance as an indicator of intervention efficacy.'}, {'measure': 'Change in mean NSSI severity levels during the 4-week follow-up period post-intervention', 'timeFrame': '6 weeks', 'description': 'It will be determined by the Suicide and Self-Injury Behavior Interview-Revised (SITBI-R). The SITBI-R assesses NSSI severity using a 5-point scale (minimum = 1, maximum = 5), where higher scores indicate more severe outcomes: Level 1 (mild NSSI without skin damage) to Level 5 (severe NSSI requiring medical intervention). Comparative analysis of severity-level changes between the active-tACS and sham-tACS groups will be conducted at the 4-week follow-up post-intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial Alternating Current Stimulation (tACS)', 'non-invasive brain stimulation'], 'conditions': ['Self-Injurious Behavior']}, 'descriptionModule': {'briefSummary': 'In order to assess the clinical efficacy of triple-daily 15mA-tACS stimulation by comparing the effects of active and sham tACS interventions on driving improvements in adolescent Nonsuicidal Self-Injury(NSSI), participants will be randomly assigned to either the active or sham tACS group. This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. The key hypothesis is that triple-daily 15mA-tACS stimulation will enhance clinical recovery compared to sham stimulation.', 'detailedDescription': 'Recognizing the clinical shortcomings of traditional methods for adolescent NSSI, study objective is to establish evidence supporting the efficacy of a triple-daily 15mA-tACS stimulation regimen targeting the forehead and both mastoids. This intervention will be administered five days a week over a four-week treatment period, with the aim of eliciting substantial clinical improvements in adolescent NSSI compared to a sham intervention. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days. Following the completion of treatment, participants will undergo follow-up observations every 7 days for 4 weeks. EEG and ECG recordings will be obtained at baseline, on day 1 after the first session, at the end of the 2-week intervention period (after 40 sessions), and at the 6-week follow-up. Throughout the sessions, all evaluations will be conducted under standardized conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of NSSI based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria section 3 diagnostic criteria.\n* Five or more NSSI episodes in the past year and at least one NSSI episode in the past month.\n* Age between 12 and 21 years.\n* Informed consent from parents or legal guardians.\n* Informed consent from participants aged 15 years and above.\n\nExclusion Criteria:\n\n* Current or history of organic brain disorders or neurological disorders.\n* Elevated or imminent suicidal risk, as assessed by clinicians during routine screening.\n* Previous or current exposure to electroconvulsive therapy (ECT), modified ECT, TMS, transcranial direct current stimulation (tDCS), tACS, or other neurostimulation treatments.\n* Presence of cochlear implants, cardiac pacemakers, implanted devices, or metal in the brain.\n* Previous or current use of psychotropic medication.\n* Pregnancy or lactation.\n* Participation in another concurrent clinical trial.\n* Refusal to provide informed consent to participate in the trial.\n* Other circumstances deemed unsuitable for participation by researchers.'}, 'identificationModule': {'nctId': 'NCT06919432', 'briefTitle': 'Efficacy of Triple-daily 15mA tACS on Adolescent NSSI', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Mental Health Center'}, 'officialTitle': 'Efficacy of Triple-daily 15mA Transcranial Alternating Current Stimulation on Adolescent Non-suicidal Self-injury (NSSI): a Double-blind, Randomized, Sham-controlled Trial', 'orgStudyIdInfo': {'id': '2024y1023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'the active-tACS group', 'description': 'This trial consists of a 2-week intensified intervention phase (40 sessions), followed by a 4-week observation period. On the first day of the intervention, participants will receive a tACS session, followed by triple-daily tACS sessions administered for 13 consecutive days.', 'interventionNames': ['Device: Active-tACS']}, {'type': 'SHAM_COMPARATOR', 'label': 'the sham-tACS group', 'description': 'Participants in the sham-tACS group will undergo the same protocol, utilizing a sham tACS incapable of delivering active stimulation. They will be kept unaware of their assigned treatment.', 'interventionNames': ['Device: Sham-tACS']}], 'interventions': [{'name': 'Active-tACS', 'type': 'DEVICE', 'description': 'Participants were comfortably positioned on a lounge chair and received alternating current stimulation using an FDA-approved tACS device (Nexalin Technology, Inc., Houston, TX, USA). Electrodes were evenly placed across the forehead and mastoid regions. Trained nurses administered the tACS according to standardized protocols.', 'armGroupLabels': ['the active-tACS group']}, {'name': 'Sham-tACS', 'type': 'DEVICE', 'description': 'The sham tACS device will resemble the active stimulation device in appearance, weight, size, color, and odor, ensuring indistinguishability for the patients. Throughout the entire intervention period, each participant will be allocated to the same tACS device, regardless of whether it delivers active or sham stimulation.', 'armGroupLabels': ['the sham-tACS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'TianHong Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhang_tianhong@126.com', 'phone': '13127577024'}], 'facility': 'Shanghai Mental Health Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'TianHong Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhang_tianhong@126.com', 'phone': '13127577024'}], 'overallOfficials': [{'name': 'TianHong Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Mental Health Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Mental Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Tianhong ZHANG', 'investigatorAffiliation': 'Shanghai Mental Health Center'}}}}