Dataset Information

Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.

ABSTRACT:

Background

Vascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND.

Methods/design

A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week (n = 108) or citicoline 300 mg/day (n = 108) in a multicenter, 6-month trial. The primary endpoint is cognition (Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)). Secondary endpoints include assessments of activities of daily living and behavioral symptoms (Clock Drawing Test (CDT), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living scale (IADL)).

Discussion

This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND. If the study confirms the effectiveness and safety of acupuncture treatment, it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare.

Trial registration

This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.

SUBMITTER: Yang BF

PROVIDER: S-EPMC4242470 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Publications

Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.

Yang Bo-Feng BF Zeng Xiang-Hong XH Liu Yan Y Fu Qing-Nan QN He Tian T Li Fang F Shi Guang-Xia GX Liu Bao-Zhen BZ Sun San-Feng SF Wang Jun J Xiao Lei L Deng Yan-Mei YM Liu Cun-Zhi CZ

Trials 20141113

<h4>Background</h4>Vascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality ...[more]

PMID: 25391431

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Project description:BackgroundMild cognitive impairment (MCI) is defined as a decline in cognitive state with preservation of activities of daily living. Medications such as donepezil and rivastigmine have been commonly prescribed for MCI, but their use is controversial. Acupuncture has been widely used in Korea and has been shown to improve cognitive function. The aim of this study is to evaluate the efficacy of acupuncture for MCI and investigate the effect of acupuncture on structural and functional brain changes in patients with MCI.MethodsThis study is a randomized, assessor-blinded, sham-controlled trial. Fifty participants with MCI will be randomly assigned to the acupuncture group (n = 25) or sham acupuncture group (n = 25). The acupuncture group will receive acupuncture treatment at nine acupuncture points (GV20, EX-HN1, bilateral LI4, and ST36) twice a week for 12 weeks. The sham acupuncture group will receive sham acupuncture treatment at the same points with non-penetrating sham needles. Both groups will be restricted from all other treatments for the improvement of cognitive function. The primary outcome measure is the Digit Span Test (DST). The secondary outcome measures are the Digit Symbol Substitution Test (DSST), Korean version of Montreal Cognitive Assessment (MoCA-K), Seoul Neuropsychological Screening Battery-II (SNSB-II), Beck Depression Inventory-II (BDI-II), State-Trait Anxiety Inventory (STAI), working memory (WM) task performance score, and structural/functional brain changes. Outcomes will be assessed at screening, baseline, 4 and 8 weeks, and after the end of treatment. We will also observe adverse events. In the statistical analysis, a full analysis set and per-protocol analysis will be performed.DiscussionThis randomized clinical trial aims to examine the efficacy of acupuncture treatment for MCI. Neuropsychological tests, psychological inventories for measuring depression and anxiety, and magnetic resonance imaging will be performed to investigate the underlying neurological mechanisms and the association between cognition, emotion, and brain networks following acupuncture treatment. The results of the trial will provide evidence supporting the efficacy of acupuncture and also add to the neurobiological understanding of acupuncture treatment for MCI.Trial registrationClinical Research Information Service, KCT0002896 . Registered on 25 May 2018.

Project description:BackgroundMild cognitive impairment and cognitive impairment, no dementia, are emerging terms that encompass the clinical state between normal cognition and dementia in elderly people. Controversy surrounds their characterization, definition and application in clinical practice. In this article, we provide physicians with practical guidance on the definition, diagnosis and treatment of mild cognitive impairment and cognitive impairment, no dementia, based on recommendations from the Third Canadian Consensus Conference on the Diagnosis and Treatment of Dementia, held in March 2006.MethodsWe developed evidence-based guidelines using systematic literature searches, with specific criteria for study selection and quality assessment, and a clear and transparent decision-making process. We selected studies published from January 1996 to December 2005 that had mild cognitive impairment or cognitive impairment, no dementia, as the outcome. Subsequent to the conference, we searched for additional articles published between January 2006 and January 2008. We graded the strength of evidence using the criteria of the Canadian Task Force on Preventive Health Care.ResultsWe identified 2483 articles, of which 314 were considered to be relevant and of good or fair quality. From a synthesis of the evidence in these studies, we made 16 recommendations. In brief, family physicians should be aware that most types of dementia are preceded by a recognizable phase of mild cognitive decline. They should be familiar with the concepts of mild cognitive impairment and of cognitive impairment, no dementia. Patients with these conditions should be closely monitored because of their increased risk for dementia. Leisure activities, cognitive stimulation and physical activity could be promoted as part of a healthy lifestyle in elderly people and those with mild cognitive impairment. Vascular risk factors should be treated optimally. No other specific therapies can yet be recommended.InterpretationPhysicians will increasingly see elderly patients with mild memory loss, and learning an approach to diagnosing states such as mild cognitive impairment is now warranted. Close monitoring for progression to dementia, promotion of a healthy lifestyle and treatment of vascular risk factors are recommended for the management of patients with mild cognitive impairment.

Project description:BACKGROUND:Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer's disease, which is the world's most common form of dementia. It is important to identify early and easily available interventions to delay the progression of MCI to Alzheimer's disease. Acupuncture has been reported to improve the clinical outcomes of MCI treatment. Acupuncture is a complex intervention, involving both specific and non-specific factors associated with therapeutic benefits. Therefore, we intend to obtain basic data for developing an optimal acupuncture treatment for MCI by comparing the effects of different acupuncture treatment methods on cognitive function in MCI patients. METHODS:This study will be a prospective, outcome-assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), randomized controlled clinical trial. Thirty-two participants with MCI will be randomized in equal numbers to four groups (basic acupuncture (BA), acupoint specificity (AS), needle duration (ND), or electroacupuncture (EA)) and receive acupuncture treatment once per day, 3 days/week for 8 weeks. The BA and ND groups will receive acupuncture treatment for 30 and 20?min, respectively, at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24). The EA group will receive electroacupuncture treatment at the same acupoints for 30?min. The AS group will receive acupuncture treatment at GV20, EX-HN1, GB20, GV24, and Taixi (KI3) for 30?min. The outcome measured will be scores on the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale, the Korean version of the Montreal Cognitive Assessment, the Center for Epidemiological Studies Depression scale, the Korean Activities of Daily Living scale, the Korean Instrumental Activities of Daily Living scale, and the European Quality of Life Five Dimension Five Level scale. All scores will be recorded before intervention, 8 weeks after the first intervention, and 12 weeks after completing the intervention. DISCUSSION:Four acupuncture protocols will be assessed and compared as potential MCI treatments. This study is expected to provide data to be used in developing an optimal acupuncture method for MCI treatment. TRIAL REGISTRATION:Clinical Research Information Service, KCT0003430 . Registered on 16 January 2019. http://cris.nih.go.kr ).

Dataset Information

Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.

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