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Safety and efficacy of acupuncture for mild cognitive impairment: a study protocol for clinical study
Jae-Hong Kim1,2, Jeong-Cheol Shin1, Ae-Ran Kim3
1Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Dongshin University, Naju, Republic of Korea.
Background:
Mild cognitive impairment (MCI) is an intermediary condition between typical cognitive decline that occurs owing to aging and dementia. It is necessary to implement an intervention to slow the progression from MCI to Alzheimer's disease. This manuscript reports the protocol for a clinical trial on the effect of acupuncture in patients with MCI.
Methods:
The trial will be a randomized, prospective, parallel-arm, active-controlled trial. Sixty-four patients with MCI will be randomized to the Rehacom or acupuncture group (n = 32 each). The participants in the acupuncture group will receive electroacupuncture at GV24 (Shenting) and GV20 (Baihui) and acupuncture at EX-HN1 (Sishencong) once (30 min) a day, twice per week for 12 weeks. The patients in the Rehacom group will receive computerized cognitive rehabilitation using RehaCom software once (30 min) daily, twice weekly for 12 weeks. The primary outcome measure is the change in the Montreal Cognitive Assessment Scale score. The secondary outcome measures are the Geriatric Depression Scale, Alzheimer's Disease Assessment Scale-Korean version-cognitive subscale-3 scores, and European Quality of Life Five Dimensions Five Level Scale. The safety outcomes will include the incidence of adverse events, blood pressure, blood chemistry parameters, and pulse rate. The efficacy outcome will be assessed at baseline and at six weeks, 13 weeks, and 24 weeks after baseline.
Discussion:
The findings of this protocol will provide information regarding the effects of acupuncture on MCI.
Clinical Trial Registration:
https://cris.nih.go.kr/cris/search/detailSearch.do?search_lang=E&focus=reset_12&search_page=M&pageSize=10&page=undefined&seq=25579&status=5&seq_group=25579, KCT0008861.
Insights
This clinical trial protocol investigates acupuncture
Area of Science:
- Neurology
- Integrative Medicine
- Clinical Trials
Background:
- Mild cognitive impairment (MCI) is a critical stage between normal aging and dementia.
- Interventions are needed to slow MCI progression to Alzheimer's disease.
Purpose of the Study:
- To report the protocol for a clinical trial assessing acupuncture's effect on MCI.
- To evaluate acupuncture as a potential intervention for managing cognitive decline.
Main Methods:
- A randomized, prospective, parallel-arm, active-controlled trial involving 64 MCI patients.
- Comparison between electroacupuncture (GV24, GV20, EX-HN1) and computerized cognitive rehabilitation (RehaCom).
- Interventions administered twice weekly for 12 weeks, with outcomes assessed over 24 weeks.
Main Results:
- Primary outcome: change in Montreal Cognitive Assessment (MoCA) Scale score.
- Secondary outcomes: Geriatric Depression Scale, ADAS-Cog-3, EQ-5D-5L scores.
- Safety outcomes: adverse events, vital signs, and blood chemistry.
Conclusions:
- This protocol will guide a trial to determine acupuncture's efficacy in treating MCI.
- Findings will inform potential therapeutic strategies for cognitive impairment.
