PMID- 36158972 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220928 IS - 1664-2295 (Print) IS - 1664-2295 (Electronic) IS - 1664-2295 (Linking) VI - 13 DP - 2022 TI - Neurological mechanism and treatment effects prediction of acupuncture on migraine without aura: Study protocol for a randomized controlled trial. PG - 981752 LID - 10.3389/fneur.2022.981752 [doi] LID - 981752 AB - INTRODUCTION: Acupuncture is an effective treatment in migraine without aura (MWoA), but the neurological mechanism has not been investigated using multimodal magnetic resonance imaging (MRI). This trial will combine functional MRI, structural MRI, and diffusion tensor imaging to explore the potential neural mechanism of acupuncture on MWoA, and will use machine learning approach to predict acupuncture treatment effects. METHODS: In this multimodal neuroimaging randomized controlled trial, a total of 60 MWoA participants will be randomly allocated to two groups: the real acupuncture treatment group and the sham acupuncture control group. This trial will include a 4-week baseline phase, a 4-week treatment phase, and a 12-week follow-up phase. Participants will undergo 12 acupuncture or sham acupuncture sessions during the treatment phase. The Headache Diary, Migraine-Specific Quality of Life Questionnaire, Headache Impact Test, Beck Depression Inventory-II, and Beck Anxiety Inventory will be utilized to evaluate the clinical efficacy. Multimodal MRI scans will be employed to investigate the mechanism of acupuncture at baseline, at the end of treatment, and after follow-up. Multimodal MRI data will be used to predict acupuncture treatment effects using machine learning technology. DISCUSSION: This study hypothesized that acupuncture therapy may treat MWoA by restoring the neuropathological alterations in brain activity. Our finding should provide valuable scientific proof for the effects of acupuncture and demonstrate the usefulness of acupuncture in the treatment of MWoA. Moreover, acupuncture response prediction might decrease healthcare expenses and time lags for patients. TRIAL REGISTRATION NUMBER: [ChiCTR2100044251]. CI - Copyright (c) 2022 Hong, Sun, Zhang, Tan, Chen, Chen, Zhu, Liu, Zhu, Zeng, Kong, Li and Liu. FAU - Hong, Jiahui AU - Hong J AD - School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing, China. AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Sun, Jingqing AU - Sun J AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Zhang, Liping AU - Zhang L AD - Department of Radiology, Dong Zhimen Hospital Beijing University of Chinese Medicine, Beijing, China. FAU - Tan, Zhongjian AU - Tan Z AD - Department of Radiology, Dong Zhimen Hospital Beijing University of Chinese Medicine, Beijing, China. FAU - Chen, Ying AU - Chen Y AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Chen, Qiuyi AU - Chen Q AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Zhu, Yupu AU - Zhu Y AD - Department of Psychology, University of Chinese Academy of Sciences, Beijing, China. FAU - Liu, Yuhan AU - Liu Y AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Zhu, Liying AU - Zhu L AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Zeng, Lin AU - Zeng L AD - Peking University Third Hospital, Research Centre of Clinical Epidemiology, Beijing, China. FAU - Kong, Yazhuo AU - Kong Y AD - Department of Psychology, University of Chinese Academy of Sciences, Beijing, China. FAU - Li, Bin AU - Li B AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. FAU - Liu, Lu AU - Liu L AD - Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China. LA - eng PT - Journal Article DEP - 20220908 PL - Switzerland TA - Front Neurol JT - Frontiers in neurology JID - 101546899 PMC - PMC9492888 OTO - NOTNLM OT - acupuncture OT - clinical trial OT - migraine without aura OT - multimodal magnetic resonance imaging OT - neurological mechanism OT - protocol OT - treatment effects prediction COIS- The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. EDAT- 2022/09/27 06:00 MHDA- 2022/09/27 06:01 PMCR- 2022/09/08 CRDT- 2022/09/26 17:29 PHST- 2022/06/29 00:00 [received] PHST- 2022/08/22 00:00 [accepted] PHST- 2022/09/26 17:29 [entrez] PHST- 2022/09/27 06:00 [pubmed] PHST- 2022/09/27 06:01 [medline] PHST- 2022/09/08 00:00 [pmc-release] AID - 10.3389/fneur.2022.981752 [doi] PST - epublish SO - Front Neurol. 2022 Sep 8;13:981752. doi: 10.3389/fneur.2022.981752. eCollection 2022.