Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT07185451
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-22
First Post:
2025-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
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', 'interventionModelDescription': 'This study uses a parallel assignment design. Participants will be randomly allocated in a 1:1 ratio to either the active tACS group or the sham stimulation group. Both groups will continue stable pharmacotherapy throughout the study. The intervention group will receive 20 sessions of active tACS over 4 weeks, while the control group will receive sham stimulation with an identical device that delivers no current. Participants remain in their assigned group for the entire duration of the study without crossover.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2025-09-15', 'studyFirstSubmitQcDate': '2025-09-15', 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in CDRS-R (Children's Depression Rating Scale) scores from baseline", 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': 'Clinical response (≥ 50% reduction in CDRS-R scores from baseline)'}], 'secondaryOutcomes': [{'measure': 'Change in BDI-II (Baker Depression Scale) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.', 'description': 'Change in BDI-II (Baker Depression Scale) scores from baseline'}, {'measure': 'Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.', 'description': 'Improvement in anxiety (SCARED minus the scores）'}, {'measure': 'Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months.', 'description': 'The severity of the suicide risk'}, {'measure': 'Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': 'Improvement in sleep status (PSQI minus the scores）'}, {'measure': 'Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': "Improvement of children's quality of life（PedsQL4.0 minus the scores)"}, {'measure': 'Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': 'Improvement in overall clinical impression severity（ 7-point scale, with 1 being normal and 7 being among the most severely damaged）'}, {'measure': 'Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': 'Improvement of clinical general Impression scale（ 7-point scale,7 denoting a very significant deterioration）'}, {'measure': 'Change in RSS (Ruminative Responses Scale)', 'timeFrame': 'Baseline of treatment period, 1 month; The follow-up period was 1 month, 3 months', 'description': 'The level of improvement in negative thinking（he higher the total score, the more reflective thinking The more severe it is）'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depression - Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '34969856', 'type': 'BACKGROUND', 'citation': 'Clancy KJ, Andrzejewski JA, You Y, Rosenberg JT, Ding M, Li W. Transcranial stimulation of alpha oscillations up-regulates the default mode network. Proc Natl Acad Sci U S A. 2022 Jan 4;119(1):e2110868119. doi: 10.1073/pnas.2110868119.'}, {'pmid': '35940423', 'type': 'BACKGROUND', 'citation': 'Jones KT, Johnson EL, Gazzaley A, Zanto TP. Structural and functional network mechanisms of rescuing cognitive control in aging. Neuroimage. 2022 Nov 15;262:119547. doi: 10.1016/j.neuroimage.2022.119547. Epub 2022 Aug 5.'}, {'pmid': '30979801', 'type': 'BACKGROUND', 'citation': 'Yan CG, Chen X, Li L, Castellanos FX, Bai TJ, Bo QJ, Cao J, Chen GM, Chen NX, Chen W, Cheng C, Cheng YQ, Cui XL, Duan J, Fang YR, Gong QY, Guo WB, Hou ZH, Hu L, Kuang L, Li F, Li KM, Li T, Liu YS, Liu ZN, Long YC, Luo QH, Meng HQ, Peng DH, Qiu HT, Qiu J, Shen YD, Shi YS, Wang CY, Wang F, Wang K, Wang L, Wang X, Wang Y, Wu XP, Wu XR, Xie CM, Xie GR, Xie HY, Xie P, Xu XF, Yang H, Yang J, Yao JS, Yao SQ, Yin YY, Yuan YG, Zhang AX, Zhang H, Zhang KR, Zhang L, Zhang ZJ, Zhou RB, Zhou YT, Zhu JJ, Zou CJ, Si TM, Zuo XN, Zhao JP, Zang YF. Reduced default mode network functional connectivity in patients with recurrent major depressive disorder. Proc Natl Acad Sci U S A. 2019 Apr 30;116(18):9078-9083. doi: 10.1073/pnas.1900390116. Epub 2019 Apr 12.'}, {'pmid': '37339227', 'type': 'BACKGROUND', 'citation': 'Chai Y, Gehrman P, Yu M, Mao T, Deng Y, Rao J, Shi H, Quan P, Xu J, Zhang X, Lei H, Fang Z, Xu S, Boland E, Goldschmied JR, Barilla H, Goel N, Basner M, Thase ME, Sheline YI, Dinges DF, Detre JA, Zhang X, Rao H. Enhanced amygdala-cingulate connectivity associates with better mood in both healthy and depressive individuals after sleep deprivation. Proc Natl Acad Sci U S A. 2023 Jun 27;120(26):e2214505120. doi: 10.1073/pnas.2214505120. Epub 2023 Jun 20.'}, {'pmid': '38476648', 'type': 'BACKGROUND', 'citation': 'Wang J, Zhao W, Wang H, Leng H, Xue Q, Peng M, Min B, Jin X, Tan L, Gao K, Wang H. Brain-wide activation involved in 15 mA transcranial alternating current stimulation in patients with first-episode major depressive disorder. Gen Psychiatr. 2024 Mar 8;37(2):e101338. doi: 10.1136/gpsych-2023-101338. eCollection 2024.'}, {'pmid': '37682331', 'type': 'BACKGROUND', 'citation': 'Biackova N, Adamova A, Klirova M. Transcranial alternating current stimulation in affecting cognitive impairment in psychiatric disorders: a review. Eur Arch Psychiatry Clin Neurosci. 2024 Jun;274(4):803-826. doi: 10.1007/s00406-023-01687-7. Epub 2023 Sep 8.'}, {'pmid': '38880208', 'type': 'BACKGROUND', 'citation': 'Zhou J, Li D, Ye F, Liu R, Feng Y, Feng Z, Li R, Li X, Liu J, Zhang X, Zhou J, Wang G. Effect of add-on transcranial alternating current stimulation (tACS) in major depressive disorder: A randomized controlled trial. Brain Stimul. 2024 Jul-Aug;17(4):760-768. doi: 10.1016/j.brs.2024.06.004. Epub 2024 Jun 14.'}, {'pmid': '33211157', 'type': 'BACKGROUND', 'citation': 'Elyamany O, Leicht G, Herrmann CS, Mulert C. Transcranial alternating current stimulation (tACS): from basic mechanisms towards first applications in psychiatry. Eur Arch Psychiatry Clin Neurosci. 2021 Feb;271(1):135-156. doi: 10.1007/s00406-020-01209-9. Epub 2020 Nov 19.'}, {'pmid': '26782765', 'type': 'BACKGROUND', 'citation': 'Bowes L, Joinson C, Wolke D, Lewis G. Peer victimisation during adolescence and its impact on depression in early adulthood: prospective cohort study in the United Kingdom. Br J Sports Med. 2016 Feb;50(3):176-83. doi: 10.1136/bjsports-2015-h2469rep.'}, {'pmid': '23497551', 'type': 'BACKGROUND', 'citation': 'Consoli A, Peyre H, Speranza M, Hassler C, Falissard B, Touchette E, Cohen D, Moro MR, Revah-Levy A. Suicidal behaviors in depressed adolescents: role of perceived relationships in the family. Child Adolesc Psychiatry Ment Health. 2013 Mar 16;7(1):8. doi: 10.1186/1753-2000-7-8.'}, {'pmid': '25692174', 'type': 'BACKGROUND', 'citation': 'Hankin BL. Depression from childhood through adolescence: Risk mechanisms across multiple systems and levels of analysis. Curr Opin Psychol. 2015 Aug;4:13-20. doi: 10.1016/j.copsyc.2015.01.003.'}, {'pmid': '31282938', 'type': 'BACKGROUND', 'citation': 'Barker MM, Beresford B, Bland M, Fraser LK. Prevalence and Incidence of Anxiety and Depression Among Children, Adolescents, and Young Adults With Life-Limiting Conditions: A Systematic Review and Meta-analysis. JAMA Pediatr. 2019 Sep 1;173(9):835-844. doi: 10.1001/jamapediatrics.2019.1712.'}, {'pmid': '24005242', 'type': 'BACKGROUND', 'citation': 'Beardslee WR, Brent DA, Weersing VR, Clarke GN, Porta G, Hollon SD, Gladstone TR, Gallop R, Lynch FL, Iyengar S, DeBar L, Garber J. Prevention of depression in at-risk adolescents: longer-term effects. JAMA Psychiatry. 2013 Nov;70(11):1161-70. doi: 10.1001/jamapsychiatry.2013.295.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of tACS treatment. To determine whether tACS can accelerate symptom remission, improve clinical response rates, and facilitate the recovery of emotional and cognitive functions through standardized clinical assessments.\n\nTo evaluate the safety of tACS treatment. To assess adverse events and side effects in both the intervention and control groups, ensuring the safety and tolerability of tACS in adolescent populations.', 'detailedDescription': 'This randomized, double-blind, sham-controlled pilot trial will evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) combined with stable pharmacotherapy in adolescents with major depressive disorder (MDD). Eligible participants are aged ≥8 years, meet DSM-5 criteria for a current depressive episode, have a CDRS-R score ≥40, and have been on stable antidepressant treatment for at least 4 weeks.\n\nA total of 30 participants will be randomized 1:1 to receive either active tACS or sham stimulation, in addition to their ongoing medication. The active group will undergo 20 sessions over 4 weeks (5 sessions per week) using the NEXALIN ADI device (77.5 Hz, 15 mA, \\~40 minutes per session). The sham device is identical in appearance but delivers no current. Both participants and operators will remain blinded.\n\nThe primary outcomes are changes in depressive symptoms measured by the CDRS-R and BDI. Secondary outcomes include anxiety (SCARED, HAMA), global improvement (CGI-S, CGI-I), suicide risk (C-SSRS), quality of life (PedsQL), sleep (PSQI), rumination (RRS), and cognition (THINC-it). Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.\n\nThis pilot study will provide preliminary evidence on the potential of tACS as an adjunctive treatment for adolescent depression and inform future large-scale trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 12-18 years.\n2. Meet DSM-5 diagnostic criteria for a current depressive episode, as confirmed by the K-SADS-PL.\n3. Children's Depression Rating Scale-Revised (CDRS-R) score ≥40 at baseline.\n4. Stable psychotropic medication treatment for at least 4 weeks prior to enrollment and willingness to continue the same regimen throughout the study.\n\nExclusion Criteria:\n\n1. Psychiatric comorbidities other than anxiety disorders.\n2. Depression with psychotic features.\n3. Young Mania Rating Scale (YMRS) score \\>13.\n4. History of neurological disorders (e.g., epilepsy, traumatic brain injury) or severe physical illnesses (e.g., thyroid disease, lupus, diabetes, significant liver, kidney, or lung impairment, major trauma).\n5. Previous treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), tACS, or other neurostimulation therapies.\n6. Current use of antiepileptic drugs or high-dose benzodiazepines.\n7. History of alcohol or substance abuse or dependence.\n8. Pregnant or breastfeeding females.\n9. Contraindications to MRI.\n10. Current high suicide risk."}, 'identificationModule': {'nctId': 'NCT07185451', 'briefTitle': 'Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Chongqing Medical University'}, 'officialTitle': 'Efficacy and Safety of Transcranial Alternating Current Stimulation (tACS) Combined With Stable Medication in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study', 'orgStudyIdInfo': {'id': '1stChongqingMU__ZXY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tACS', 'description': 'Participants in this group will receive transcranial alternating current stimulation (tACS) in addition to their ongoing stable pharmacotherapy. tACS will be delivered using the NEXALIN ADI device (Beijing Neslin Technology Co., Ltd.) with a frequency of 77.5 Hz and current intensity of 15 mA. One electrode is placed on the forehead and two electrodes on the mastoid processes. Each session lasts approximately 40 minutes, with a total of 20 sessions administered over 4 weeks (5 sessions per week). The intervention aims to modulate cortical activity and improve depressive symptoms, cognitive function, and emotional regulation.', 'interventionNames': ['Device: tACS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Participants in this group will receive sham stimulation in addition to their ongoing stable pharmacotherapy. A sham device identical in appearance, sound, and operation to the active tACS device will be used but will not deliver any electrical current. Treatment is administered in the same schedule as the active group (20 sessions over 4 weeks, 5 sessions per week). Both participants and operators are blinded to the treatment assignment to ensure study integrity.', 'interventionNames': ['Device: tACS']}], 'interventions': [{'name': 'tACS', 'type': 'DEVICE', 'description': 'This intervention uses the NEXALIN ADI alternating current stimulation device from Beijing Naisilin Technology Co., Ltd., to deliver targeted stimulation to the prefrontal cortex and bilateral mastoid regions. The prefrontal cortex electrode directly stimulates the cerebral cortex, while the mastoid electrodes ensure the synchronized activation of bilateral neural pathways. Stimulation is applied at a frequency of 77.5 Hz and a current intensity of 15 mA, aiming to optimize brainwave synchronization and modulate brain activity.\n\nParticipants will undergo daily sessions lasting approximately 40 minutes each, for a total of 20 sessions over 4 weeks. The non-invasive nature of the intervention, combined with its precise targeting of specific brain regions, distinguishes it from other neuromodulation therapies. The treatment aims to enhance neural synchronization, promote neuroplasticity, and provide a non-pharmacological therapeutic alternative for patients.', 'armGroupLabels': ['tACS']}, {'name': 'tACS', 'type': 'DEVICE', 'description': "In the sham stimulation group, participants will receive intervention using a sham device that is identical in appearance, operation, and stimulation protocol to the real tACS device, but does not deliver any current. Both participants and operators will be unable to distinguish between real and sham stimulation based on the device's appearance, sound, or tactile feedback. Device allocation will follow a randomized code generated in advance to ensure blinding and proper group assignment.", 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40000', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Xinyu Zhou', 'role': 'CONTACT', 'email': 'zhouxinyu@cqmu.edu.cn', 'phone': '15823996993'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Xinyu Zhou', 'role': 'CONTACT', 'email': 'zhouxinyu@cqmu.edu.cn', 'phone': '15823996993'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Chongqing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xinyu Zhou', 'investigatorAffiliation': 'First Affiliated Hospital of Chongqing Medical University'}}}}