Key result
Combined neurofeedback and acupuncture treatment will be evaluated for its efficacy in improving cognitive function compared to acupuncture alone in a planned pilot trial of 44 patients with mild neurocognitive disorder.
Why the study?
Acupuncture and neurofeedback training are used to improve cognitive function in mild neurocognitive disorder, but their effectiveness remains controversial.
Does combined neurofeedback and acupuncture improve cognitive function in patients with mild neurocognitive disorder compared to acupuncture alone?
RCT (n=44)
Assessor-blind
Stratified block randomization
No
Does combined neurofeedback and acupuncture improve cognitive function in patients with mild neurocognitive disorder compared to acupuncture alone?
This trial protocol outlines a study to evaluate whether adding neurofeedback to acupuncture improves cognitive outcomes in patients with mild neurocognitive disorder.
Pilot data on NF-acupuncture for MND; leaves open comparative efficacy and warrants larger trials.
BACKGROUND: Mild neurocognitive disorder (MND) is an intermediate state that can progress to dementia, and the cognitive reserve of MND is an important task in preventing dementia. Acupuncture and neurofeedback (NF) training have been used to improve cognitive function and treat MND or dementia, but their effectiveness remains controversial. In this trial, we will evaluate the efficacy and safety of combined NF-acupuncture treatment in comparison with single acupuncture treatment. METHODS AND DESIGN: This study is a randomized, assessor-blind, pilot trial. It is designed in accordance with the Standards for Reporting Interventions in Controlled Trials of Acupuncture. A total of 44 MND participants who meet the inclusion and exclusion criteria will be enrolled, and each will be randomly assigned to 1 of 2 groups of 22 subjects. Each subject will visit 24 times over 12 weeks and receive either acupuncture or NF-acupuncture combined treatment. At visit 25 (week 13), a follow-up evaluation will be performed, and then the investigator will analyze the results. The primary outcome is defined by the Korean version of the Montreal Cognitive Assessment score from screening to visit 25. The secondary outcome includes the following: change in Alzheimer Disease Assessment Scale-Cognitive, the Korean version of the Beck Depression Inventory, Body Awareness Questionnaire, delayed matching to sample task scores, and functional near-infrared spectroscopy values, from visit 1 to visit 25; heart rate variability values from visit 1 to visit 5, visit 9, visit 13, visit 21, visit 25; breath per minute values from visit 1 to visit 1 to 25. DISCUSSION: We will evaluate the effectiveness and safety of combined NF-acupuncture therapy, and expect that it will serve as the basis for the use of NF together with acupuncture in the clinical setting. TRIAL REGISTRATION NUMBER: KCT0004972 (registered in Clinical Research Information Service of the Republic of Korea, https://cris.nih.go.kr/cris/search/detailSearch.do/16239).
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Jeong et al. (2021) conducted an RCT in Mild neurocognitive disorder (n=44). Combined neurofeedback and acupuncture vs. Acupuncture alone was evaluated on Change in the Korean version of Montreal Cognitive Assessment (MoCA-K) score from screening to visit 25. Combined neurofeedback and acupuncture treatment will be evaluated for its efficacy in improving cognitive function compared to acupuncture alone in a planned pilot trial of 44 patients with mild neurocognitive disorder.
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