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Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial
  1. Chao-Qun Yan1,2,
  2. Ping Zhou1,
  3. Xu Wang3,
  4. Jian Feng Tu1,
  5. Shang-Qing Hu1,
  6. Jian-Wei Huo4,
  7. Zhong-Yan Wang4,
  8. Guang-Xia Shi1,
  9. Ya-Nan Zhang4,
  10. Jun-Qiu Li4,
  11. Jun Wang2,
  12. Cun-Zhi Liu1
  1. 1School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China
  2. 2Department of Acupuncture and moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China
  3. 3School of Life Sciences, Beijing University of Chinese Medicine, Beijing, China
  4. 4Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China
  1. Correspondence to Professor Cun-Zhi Liu; lcz_tg{at}126.com

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.

  • Subjective cognitive decline
  • Dementia
  • Acupuncture
  • Sham acupuncture
  • Magnetic Resonance Imaging
  • Clinical trial

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Footnotes

  • Contributors CZL and JWH conceived and designed the experiments. PZ, ZYW, SQH, CQY, GXS, JQL and YNZ performed the experiments. XW, JW and JFT analysed the data. CQY, XW and CZL wrote the paper. All authors approved the final manuscript.

  • Funding This work was supported by the National Natural Science Foundation of China (Grant No 81674055) and supported by the Fundamental Research Funds for the Central Universities (2017-JYB-JS-018).

  • Disclaimer We declared the study was only supported by the governmental funding, and the study did not receive funding/assistance from a commercial organisation.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Ethics approval Ethics Committee of the Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (Ref: 2017BL-061-02).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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