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BMJ Open. 2019 Oct 10;9(10):e028317. doi: 10.1136/bmjopen-2018-028317.

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

Author information

1
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China.
2
Department of Acupuncture and moxibustion, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
3
School of Life Sciences, Beijing University of Chinese Medicine, Beijing, China.
4
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, China.
5
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, China lcz_tg@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.

KEYWORDS:

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

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