Background: Mild cognitive impairment (MCI) is defined as an intermediate stage between normal aging and Alzheimer's disease (AD), and early and easily available interventions to delay the progress of MCI to AD are necessary. Feasible complementary and alternative therapies such as electroacupuncture (EA), exercise, and cognitive training have shown some beneficial effects on MCI and AD. Here we report the protocol for a randomized controlled trial of the efficacy and safety of EA combined with computer-based cognitive rehabilitation (EA-CCR) for the treatment of MCI.
Methods: The study will be a prospective, outcome assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial with a 1:1 allocation ratio. Participants with MCI will be randomized to a computer-based cognitive rehabilitation (CCR) or an EA-CCR group (n = 18 each). The CCR group will receive RehaCom cognitive rehabilitation once (30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The EA-CCR group will receive EA at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24) in addition to RehaCom cognitive rehabilitation once (EA:30 min, CCR:30 min) a day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The primary outcome will be an improvement in cognitive function assessed using the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale. Scores for the Korean version of the Montreal Cognitive Assessment scale, Center for Epidemiological Studies Depression Scale, Korean Activities of Daily Living scale, Korean Instrumental Activities of Daily Living scale, and European Quality of Life Five Dimension Five Level Scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 8 weeks after the first intervention (i.e., at the end of the intervention), and 12 weeks after completion of the intervention.
Discussion: The study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of EA-CCR for the treatment of MCI.
Trial registration: Korea Clinical Information Service, cris.nih.go.kr, KCT0003415 . Registered on 4 January 2019. Retrospectively registered, http://cris.nih.go.kr .
Keywords: Computer-based cognitive rehabilitation; Electroacupuncture; Mild cognitive impairment; Randomized controlled trial; Study protocol.