Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial
Introduction Depression is characterised by disruptions in brain circuitry, and interventions like intermittent theta burst stimulation (iTBS) offer the potential for normalising these circuits and improving clinical symptoms. However, personalised treatment targets for depression remain underexplor...
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BMJ Publishing Group
2025-07-01
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| Online Access: | https://bmjopen.bmj.com/content/15/7/e098155.full |
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| author | Ling Zhang Ping Zhang Wuxiang Xie Hao Cheng Kai Wang Yongbo Hu Qiyong Gong Weihong Kuang Meiyun Wang Gang Wang Liang Li Wen Qin Weihua Yue Dai Zhang Lijuan Chen Gongjun Ji Hesheng Liu Meiling Li Chunshui Yu Ziqiang Li Yuyanan Zhang Yansheng Jiang Sixiang Liang Xiaoyue Sun Zekun Yang |
| author_facet | Ling Zhang Ping Zhang Wuxiang Xie Hao Cheng Kai Wang Yongbo Hu Qiyong Gong Weihong Kuang Meiyun Wang Gang Wang Liang Li Wen Qin Weihua Yue Dai Zhang Lijuan Chen Gongjun Ji Hesheng Liu Meiling Li Chunshui Yu Ziqiang Li Yuyanan Zhang Yansheng Jiang Sixiang Liang Xiaoyue Sun Zekun Yang |
| author_sort | Ling Zhang |
| collection | DOAJ |
| description | Introduction Depression is characterised by disruptions in brain circuitry, and interventions like intermittent theta burst stimulation (iTBS) offer the potential for normalising these circuits and improving clinical symptoms. However, personalised treatment targets for depression remain underexplored. This trial aims to evaluate the clinical efficacy of iTBS as an additional treatment to a stable antidepressant regimen in patients with treatment-resistant depression (TRD) by modulating brain circuits identified through personalized brain functional sectors compared with sham treatment. This work is a part of the China Study to Predict Optimised Treatment bioMarkers of Individualised Neuromodulation in Depression project.Methods and analysis This is a multi-centre, double-blind, sham-controlled randomised trial, with a 2:1 allocation ratio to 21 days of active or sham iTBS. A total of 360 eligible participants, diagnosed with current treatment-resistant unipolar major depressive disorder, who have been on a stable antidepressant regimen for at least 4 weeks and are experiencing moderate-to-severe depressive episodes, will be recruited from seven clinical centres in China. The primary outcome is the change in the Montgomery–Asberg Depression Rating Scale immediately following 21-day treatment. Secondary outcomes include response rate and remission rate, change in the Hamilton Rating Scale for Depression, efficacy sustainability and recurrence within 6 months post-treatment. Additionally, safety, blinding, dropout and potential moderators of response will be examined.Ethics and dissemination The study has been approved by each centre’s ethics committee, with the first ethical approval granted by the Ethics Committee of Beijing Anding Hospital on 30 December 2022 (approval 2022206FS-2). Written informed consent will be obtained from all participants prior to enrolment. The study results will be published in relevant peer-reviewed journals. |
| format | Article |
| id | doaj-art-79932f5d5b1b4ee885c1e2b456b628ec |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-79932f5d5b1b4ee885c1e2b456b628ec2025-08-20T02:43:36ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2024-098155Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trialLing Zhang0Ping Zhang1Wuxiang Xie2Hao Cheng3Kai Wang4Yongbo Hu5Qiyong Gong6Weihong Kuang7Meiyun Wang8Gang Wang9Liang Li10Wen Qin11Weihua Yue12Dai Zhang13Lijuan Chen14Gongjun Ji15Hesheng Liu16Meiling Li17Chunshui Yu18Ziqiang Li19Yuyanan Zhang20Yansheng Jiang21Sixiang Liang22Xiaoyue Sun23Zekun Yang24Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital Capital Medical University, Beijing, ChinaNeural Galaxy, Beijing, ChinaClinical Research Institute, Institute of Advanced Clinical Medicine, Peking University, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDepartment of Neurology, First Affiliated Hospital of Anhui Medical University, Hefei, ChinaDepartment of Radiology, Huaxi MR Research Center (HMRRC), Institute of Radiology, Functional and Molecular Imaging Key Laboratory of Sichuan Province, West China Hospital of Sichuan University, Chengdu, ChinaDepartment of Radiology, Huaxi MR Research Center (HMRRC), Institute of Radiology, Functional and Molecular Imaging Key Laboratory of Sichuan Province, West China Hospital of Sichuan University, Chengdu, ChinaDepartment of Psychiatry, West China Hospital of Sichuan University, Chengdu, ChinaDepartment of Radiology, Henan Provincial People’s Hospital, Zhengzhou, ChinaBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital Capital Medical University, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDepartment of Radiology and Tianjin Key Laboratory of Functional Imaging, Tianjin Medical University General Hospital, Tianjin, ChinaPeking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDepartment of Radiology, Henan Provincial People’s Hospital, Zhengzhou, ChinaSchool of Mental Health and Psychological Sciences, Anhui Medical University, Hefei, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDepartment of Radiology and Tianjin Key Laboratory of Functional Imaging, Tianjin Medical University General Hospital, Tianjin, ChinaPsychiatry Department, The 5th People’s Hospital of Luoyang, Luoyang, ChinaPeking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Beijing, ChinaPsychiatry Department, The 5th People’s Hospital of Luoyang, Luoyang, ChinaBeijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital Capital Medical University, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaIntroduction Depression is characterised by disruptions in brain circuitry, and interventions like intermittent theta burst stimulation (iTBS) offer the potential for normalising these circuits and improving clinical symptoms. However, personalised treatment targets for depression remain underexplored. This trial aims to evaluate the clinical efficacy of iTBS as an additional treatment to a stable antidepressant regimen in patients with treatment-resistant depression (TRD) by modulating brain circuits identified through personalized brain functional sectors compared with sham treatment. This work is a part of the China Study to Predict Optimised Treatment bioMarkers of Individualised Neuromodulation in Depression project.Methods and analysis This is a multi-centre, double-blind, sham-controlled randomised trial, with a 2:1 allocation ratio to 21 days of active or sham iTBS. A total of 360 eligible participants, diagnosed with current treatment-resistant unipolar major depressive disorder, who have been on a stable antidepressant regimen for at least 4 weeks and are experiencing moderate-to-severe depressive episodes, will be recruited from seven clinical centres in China. The primary outcome is the change in the Montgomery–Asberg Depression Rating Scale immediately following 21-day treatment. Secondary outcomes include response rate and remission rate, change in the Hamilton Rating Scale for Depression, efficacy sustainability and recurrence within 6 months post-treatment. Additionally, safety, blinding, dropout and potential moderators of response will be examined.Ethics and dissemination The study has been approved by each centre’s ethics committee, with the first ethical approval granted by the Ethics Committee of Beijing Anding Hospital on 30 December 2022 (approval 2022206FS-2). Written informed consent will be obtained from all participants prior to enrolment. The study results will be published in relevant peer-reviewed journals.https://bmjopen.bmj.com/content/15/7/e098155.full |
| spellingShingle | Ling Zhang Ping Zhang Wuxiang Xie Hao Cheng Kai Wang Yongbo Hu Qiyong Gong Weihong Kuang Meiyun Wang Gang Wang Liang Li Wen Qin Weihua Yue Dai Zhang Lijuan Chen Gongjun Ji Hesheng Liu Meiling Li Chunshui Yu Ziqiang Li Yuyanan Zhang Yansheng Jiang Sixiang Liang Xiaoyue Sun Zekun Yang Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial BMJ Open |
| title | Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial |
| title_full | Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial |
| title_fullStr | Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial |
| title_full_unstemmed | Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial |
| title_short | Personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment-resistant depression: a study protocol for a multi-centre, randomised, double-blind, sham-controlled clinical trial |
| title_sort | personalized brain functional sectors guided theta burst transcranial magnetic stimulation for treatment resistant depression a study protocol for a multi centre randomised double blind sham controlled clinical trial |
| url | https://bmjopen.bmj.com/content/15/7/e098155.full |
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