Effect of acupuncture on patients with mild cognitive impairment assessed using functional near-infrared spectroscopy on week 12 (close-out): a pilot study protocol

Background: Currently, there is no clearly established therapy to treat mild cognitive impairment (MCI); consequently, alternative therapies, such as acupuncture, have been attempted. In many clinical studies, the potential benefits of acupuncture for cognitive improvement have been identified in clinical outcomes; however, the mechanism remains unclear. Accordingly, this study aims to investigate the therapeutic mechanism of acupuncture therapy using functional near-infrared spectroscopy and its feasibility in treating individuals with impaired cognitive function. Methods: This study is designed to be a prospective, two-arm, parallel clinical trial involving 24 participants. The patient group will be treated with acupuncture twice per week for 12 weeks; meanwhile, the healthy control group will not undergo acupuncture treatment. Functional near-infrared spectroscopy assessment and a working memory test will be performed at baseline and every 6 weeks to investigate the therapeutic mechanism of acupuncture. The primary outcome will be measured using the Korean version of the Montreal Cognitive Assessment. The secondary outcomes will be the Alzheimer's Disease Assessment Scale-cognitive subscale score, working memory task accuracy, response rate, response time, and hemodynamic response of the prefrontal lobe. The outcomes will be evaluated at baseline, and at 6 and 12 weeks after subject allocation. Discussion: This clinical pilot trial is designed to determine the feasibility of acupuncture as an effective and safe treatment for improving cognitive function in patients with MCI. Results of this study may provide guidance for future larger-scale clinical trials. Trial registration: Clinical Research Information Service (CRIS), Republic of Korea: KCT0002451. Registered September 5, 2017. Keywords: Acupuncture, Functional near-infrared spectroscopy, Mild cognitive impairment