Neurological mechanism and treatment effects prediction of acupuncture on migraine without aura: Study protocol for a randomized controlled trial

Jiahui Hong; Jingqing Sun; Liping Zhang; Zhongjian Tan; Ying Chen; Qiuyi Chen; Yupu Zhu; Yuhan Liu; Liying Zhu; Lin Zeng; Yazhuo Kong; Bin Li; Lu Liu

doi:10.3389/fneur.2022.981752

Neurological mechanism and treatment effects prediction of acupuncture on migraine without aura: Study protocol for a randomized controlled trial

Front Neurol. 2022 Sep 8:13:981752. doi: 10.3389/fneur.2022.981752. eCollection 2022.

Authors

Jiahui Hong^{1

2}, Jingqing Sun², Liping Zhang³, Zhongjian Tan³, Ying Chen², Qiuyi Chen², Yupu Zhu⁴, Yuhan Liu², Liying Zhu², Lin Zeng⁵, Yazhuo Kong⁴, Bin Li², Lu Liu²

Affiliations

¹ School of Clinical Medicine, Beijing University of Chinese Medicine, Beijing, China.
² Department of Acupuncture and Moxibustion, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Key Laboratory of Acupuncture Neuromodulation, Beijing, China.
³ Department of Radiology, Dong Zhimen Hospital Beijing University of Chinese Medicine, Beijing, China.
⁴ Department of Psychology, University of Chinese Academy of Sciences, Beijing, China.
⁵ Peking University Third Hospital, Research Centre of Clinical Epidemiology, Beijing, China.

Abstract

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].

Keywords: acupuncture; clinical trial; migraine without aura; multimodal magnetic resonance imaging; neurological mechanism; protocol; treatment effects prediction.