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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Efficacy of electrical acupuncture on vascular cognitive impairment with no dementia: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Tian Li, Huangan Wu, Franscisca Soto-Aguliar, Li Huang, Wentao Li, Lixing Lao, Shifen Xu
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2458-1) contains supplementary material, which is available to authorized users.

Abstract

Background

Vascular cognitive impairment with no dementia (VCIND), manifested mainly as mild impairment of concentration and executive function, is the early phase of vascular dementia (VD). Currently, there is no specific treatment for VCIND. We hypothesize that electrical acupuncture can improve the mental and motor functions of patients with VCIND. Thus, we designed this randomized controlled trial to test this hypothesis by comparing the therapeutic effect of electrical acupuncture versus sham acupuncture in patients with VCIND.

Method/Design

In this single-center 3-year study, 120 eligible patients will be recruited and randomly assigned to receive electrical acupuncture treatment (n = 60) or sham acupuncture (n = 60) for 8 consecutive weeks (24 sessions in total), with the same acupoint prescription (DU20, EX-HN3, DU24, DU17, DU26, EX-HN1, HT7, PC6, GB20, SP6). The primary assessment is the Montreal Cognitive Assessment. The secondary assessments are the Modified Barthel Index and Event-Related Potential. All outcomes will be assessed at baseline, endpoint, and follow-up at 8 and 24 weeks after the end of treatment.

Discussion

If the outcome confirms the effectiveness and safety of electrical acupuncture in treating VCIND, this treatment is expected to be promoted in clinical practice to treat such patients.

Trial Registration

Chinese Clinical Trial Registry identifier: ChiCTR-IIR-17011513; Registered on 27 May 2017.
Zusatzmaterial
Additional file 1: The SPIRIT checklist. (DOC 107 kb)
13063_2018_2458_MOESM1_ESM.doc
Additional file 2: The informed consent form. (DOCX 15 kb)
13063_2018_2458_MOESM2_ESM.docx
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