Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial

Chao-Qun Yan, Ping Zhou, Xu Wang, Jian Feng Tu, Shang-Qing Hu, Jian-Wei Huo, Zhong-Yan Wang, Guang-Xia Shi, Ya-Nan Zhang, Jun-Qiu Li, Jun Wang, Cun-Zhi Liu, Chao-Qun Yan, Ping Zhou, Xu Wang, Jian Feng Tu, Shang-Qing Hu, Jian-Wei Huo, Zhong-Yan Wang, Guang-Xia Shi, Ya-Nan Zhang, Jun-Qiu Li, Jun Wang, Cun-Zhi Liu

Abstract

Introduction: Subjective cognitive decline (SCD) refers to individuals' perceived decline in memory and/or other cognitive abilities relative to their previous level of performance, while objective neuropsychological deficits are not observed. SCD may represent a preclinical phase of Alzheimer's disease. At this very early stage of decline, intervention could slow the rate of incipient decline to prolong and preserve cognitive and functional abilities. However, there is no effective treatment recommended for individuals with SCD. Acupuncture, as a non-pharmacological intervention, has been widely employed for patients with cognitive disorders.

Methods and analysis: The proposed study is a randomised, assessor-blinded and placebo-controlled study that investigates the efficacy and mechanism of acupuncture in SCD. Sixty patients with SCD will be randomly allocated either into an acupuncture group or a sham acupuncture group. They will receive 24 sessions of real acupuncture treatment or identical treatment sessions using a placebo needle. Global cognitive changes based on a multidomain neuropsychological test battery will be evaluated to detect the clinical efficacy of acupuncture treatment at baseline and end of treatment. MRI scans will be used to explore acupuncture-related neuroplasticity changes. Correlation analyses will be performed to investigate the relationships between the changes in brain function and symptom improvement.

Ethics and dissemination: The trial was approved by the research ethics committee. The results of the study will be published in a peer-reviewed academic journal and will also be disseminated electronically through conference presentations.

Trial registration number: NCT03444896.

Keywords: Acupuncture; Clinical trial; Dementia; Magnetic Resonance Imaging; Sham acupuncture; Subjective cognitive decline.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart.
Figure 2
Figure 2
Location of acupoints or sham acupoints in the trial. BL15, Xinshu; BL45, Yixi; DU16, Fengfu; DU20, Baihui; DU24, Shengting; GB20, Fengchi; HT5, Tongli; KI6, Zhaohai; PC6, Neiguan; RN6, Qihai; RN12, Zhongwan; RN17, Danzhong; SA, sham acupoint; SP10, Xuehai; ST36, Zusanli.
Figure 3
Figure 3
MRI experimental paradigm and an illustrative diagram of the memory task. ASL, arterial spin labelling; DTI, diffusion tensor imaging.
Figure 4
Figure 4
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and the schedule of the trial. AFT, Animal Fluency Test; AVLT, Auditory Verbal Learning Test; DSST, Digit Symbol Substitution Test; SBSDS,Santa Barbara Sense of Direction Scale; HAMD, Hamilton Rating Scale forDepression; HAMA, Hamilton Rating Scale for Anxiety; PSQI, Pittsburgh Sleep Quality Index; SCDQ, Subjective Cognitive Decline Questionnaire; SCWT, Stroop Color and Word Test; TMT, Trail Making Test.

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