Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial

Authors: Albert Wing Nang Leung, Linda Chiu Wa Lam, Andrew Ka Lun Kwan, Celia Lai Lin Tsang, Hong Wei Zhang, Yuan Qi Guo, Chuan Shan Xu

Published in: Trials | Issue 1/2015

Login to get access

Abstract

Background

Mild cognitive impairment is an intermediary state between normal aging and clinical Alzheimer’s disease. Early intervention of mild cognitive impairment may be an important strategy in the management of Alzheimer’s disease. The proposal aims to evaluate if electroacupuncture would optimize cognitive function in subjects with mild cognitive impairment and understand the role of electroacupuncture in the treatment of Alzheimer’s disease.

Methods/design

A randomised patient- and assessor-blind sham-controlled trial is designed to assess whether electroacupuncture intervention decreases the rate of cognitive decline amongst older adults with mild cognitive impairment. One hundred and fifty subjects aged 65 years of age or over with a diagnosis of mild cognitive impairment are recruited from the community and elderly centre in Hong Kong. All subjects are randomly allocated into two groups (75 subjects each group): the electroacupuncture group and sham control. Participants in the electroacupuncture group receive electroacupuncture stimulation by sterile, disposable acupuncture needles inserted to the acupoints with a depth of 1 to 3 cm. The acupuncture needles are subjected to 2 Hz electroacupuncture wihtat an intensity of 5 to 10 mA. Each participant receives electroacupuncture for 8 weeks (once a day, 3 days a week) and the treatment lasts for 30 minutes each time. For sham electroacupuncture, needles are inserted to a depth of 1 to 2 mm, and connected to the electroacupuncture device without any current passing through. Outcome measures (including primary and secondary outcome measures) are collected at baseline, at the end day of intervention, and months 4 and 6 after intervention. The primary outcome is measured by the Alzheimer Disease Assessment Scale-Cognitive subscale. Secondary outcomes are measured by the mini-mental state examination, category fluency text and the Short Form 12.

Discussion

The study will provide evidence for evaluating and understanding the role of electroacupuncture in the treatment of Alzheimer’s disease.

Trial registration

This trial is registered with chictr.org (registration number: ChiCTR-TRC-12002414. Registration date: 11 August 2012.
Literature
1.
Gentile S. Second-generation antipsychotics in dementia: beyond safety concerns. A clinical, systematic review of efficacy data from randomised controlled trials. Psychopharmacology (Berl). 2010;212:119–29.CrossRef
2.
Vidovich MR, Lautenschlager NT, Flicker L, Clare L, Almeida OP. The PACE study: a randomised clinical trial of cognitive activity (CA) for older adults with mild cognitive impairment (MCI). Trials. 2009;10:114.CrossRefPubMedPubMedCentral
3.
Workman B, Dickson F, Green S. Early dementia - optimal management in general practice. Aust Fam Physician. 2010;39:722–6.PubMed
4.
Chan MC, Chong CS, Wu AY, Wong KC, Dunn EL, Tang OW, et al. Antipsychotics and risk of cerebrovascular events in treatment of behavioural and psychological symptoms of dementia in Hong Kong: a hospital-based, retrospective, cohort study. Int J Geriatr Psychiatry. 2010;25:362–70.CrossRefPubMed
5.
Chan WC, Lam LC, Tam CW, Lui VW, Chan SS, Chan WM, et al. Prevalence of neuropsychiatric symptoms in chinese older persons with mild cognitive impairment - a population-based study. Am J Geriatr Psychiatry. 2010;18:948–54.CrossRefPubMed
6.
Saxton J, Snitz BE, Lopez OL, Ives DG, Dunn LO, Fitzpatrick A, et al. GEM Study Investigators. Functional and cognitive criteria produce different rates of mild cognitive impairment and conversion to dementia. J Neurol Neurosurg Psychiatry. 2009;80:737–43.CrossRefPubMedPubMedCentral
7.
Brooks LG, Loewenstein DA. Assessing the progression of mild cognitive impairment to Alzheimer’s disease: current trends and future directions. Alzheimers Res Ther. 2010;2:28.PubMedPubMedCentral
8.
Levin OS, Yunishchenko NA, Dudarova MA. Efficacy of aktinol memantine in moderate cognitive impairments. Neurosci Behav Physiol. 2010;40:926–33.CrossRefPubMed
9.
Yeung W, Chung K, Leung Y, Zhang S, Law ACK. Traditional needle acupuncture treatment of insomnia: a systematic review of randomized controlled trials. Sleep Med. 2009;10:694–704.CrossRefPubMed
10.
Lin CC, Chen MC, Yu SN, Ju MS. Chronic electrical stimulation of four acupuncture points on rat diabetic neuropathy. Conf Proc IEEE Eng Med Biol Soc. 2005;4:4271–4.PubMed
11.
Dos Santos Jr JG, Tabosa A, Do Monte FH, Blanco MM, De Oliveira Freire A, Mello LE. Electroacupuncture prevents cognitive deficits in pilocarpine-epileptic rats. Neurosci Lett. 2005;384:234–8.CrossRefPubMed
12.
Jing XH, Chen SL, Shi H, Cai H, Jin ZG. Electroacupuncture restores learning and memory impairment induced by both diabetes mellitus and cerebral ischemia in rats. Neurosci Lett. 2008;443:193–8.CrossRefPubMed
13.
Xue WG, Ge GL, Zhang Z, Xu H, Bai LM. Effect of electroacupuncture on the behavior and hippocampal ultrastructure in APP 695 V 717 I transgenic mice. Zhen Ci Yan Jiu. 2009;34:309–14.PubMed
14.
Xue WG, Zhang Z, Bai LM, Xu H, Wu HX. Effect of electroacupuncture on the behavior and the expression of amyloid beta-protein, amyloid precursor protein and ChAT in APP 695 V 717 I transgenic mice. Zhen Ci Yan Jiu. 2009;34:152–8.PubMed
15.
Zhao L, Zhang H, Zheng Z, Huang J. Electroacupuncture on the head points for improving gnosia in patients with vascular dementia. J Tradit Chin Med. 2009;29:29–34.CrossRefPubMed
16.
Lee MS, Shin BC, Ernst E. Acupuncture for Alzheimer’s disease: a systematic review. Int J Clin Pract. 2009;63:874–9.CrossRefPubMed
17.
Peng WN, Zhao H, Liu ZS, Wang S. Acupuncture for vascular dementia. Cochrane Database Syst Rev. 2007;2:CD004987.PubMed
18.
Lam LC, Tam CW, Lui VW, Chan WC, Chan SS, Chiu HF, et al. Screening of mild cognitive impairment in Chinese older adults - a multistage validation of the Chinese abbreviated mild cognitive impairment test. Neuroepidemiology. 2008;30:6–12.CrossRefPubMed
19.
Liu XP, Liu ZY. Advances of acupuncture and moxibustion for cognitive impairment. Xinjiang J Tradit Chin Med. 2009;27:85–7.
20.
Yang CZ, Zong J, Zhu AH. Study on the syndrome of senile minor cognitive injury. J Beijing Univ Tradit Chin Med (Clin Med). 2003;10:12–6.
21.
Zhang HW, Tang JL. Design and choice of placebo acupuncture in clinical trial. Chin J Integr Tradit West Med. 2003;23:247–503.
22.
White AR, Filshie J, Cummings TM. International Acupuncture Research Forum. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001;9:237–45.CrossRefPubMed
23.
Van Uffelen JG, Hopman-Rock M, Chin A, Paw MJ, van Mechelen W. Protocol for Project FACT: a randomised controlled trial on the effect of a walking program and vitamin B supplementation on the rate of cognitive decline and psychosocial wellbeing in older adults with mild cognitive impairment [ISRCTN19227688]. BMC Geriatr. 2005;5:18.CrossRefPubMedPubMedCentral
24.
Yang BF, Zeng XH, Liu Y, Fu QN, He T, He T, et al. Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial. Trials. 2014;15:442–6.CrossRefPubMedPubMedCentral
25.
Zhu YL, Jia JP. Clinical observation on catgut implantation at acupoint for treatment of Alzheimer’s disease. Chin Acupunct Moxibustion. 2008;28:37–40.
26.
de Jong D, Jansen R, Hoefnagels W, Jellesma-Eggenkamp M, Verbeek M, Borm G, et al. No effect of one-year treatment with indomethacin on Alzheimer’s disease progression: a randomized controlled trial. PLoS One. 2008;3:e1475.CrossRefPubMedPubMedCentral
27.
Rafii MS, Walsh S, Little JT, Behan K, Reynolds B, Ward C, et al. Alzheimer’s disease cooperative study. A phase II trial of huperzine A in mild to moderate. Alzheimer Dis Neurol. 2011;76:1389–94.
Metadata
Title
Electroacupuncture for older adults with mild cognitive impairment: study protocol for a randomized controlled trial
Authors
Albert Wing Nang Leung
Linda Chiu Wa Lam
Andrew Ka Lun Kwan
Celia Lai Lin Tsang
Hong Wei Zhang
Yuan Qi Guo
Chuan Shan Xu
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0740-z

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Research

A simple technique to identify key recruitment issues in randomised controlled trials: Q-QAT - quanti-qualitative appointment timing

Study protocol

Effects of exercise training and photobiomodulation therapy (EXTRAPHOTO) on pain in women with fibromyalgia and temporomandibular disorder: study protocol for a randomized controlled trial

Study protocol

Clinical effectiveness and micro-perfusion alteration of Jingui external lotion in patients with knee osteoarthritis: study protocol for a randomized controlled trial

Study protocol

Fuzheng Kang’ai decoction combined with gefitinib in advanced non-small cell lung cancer patients with epidermal growth factor receptor mutations: study protocol for a randomized controlled trial

Study protocol

A pilot feasibility, safety and biological efficacy multicentre trial of therapeutic hypercapnia after cardiac arrest: study protocol for a randomized controlled trial

Research

Effective recruitment of participants to a phase I study using the internet and publicity releases through charities and patient organisations: analysis of the adaptive study of IL-2 dose on regulatory T cells in type 1 diabetes (DILT1D)