The Effect of Electroacupuncture Treatment on Cognitive Function in Adults with Amnestic Mild Cognitive Impairment
- Conditions
- Amnestic Mild Cognitive Impairment - AMCI
- Interventions
- Device: Electroacupuncture
- Registration Number
- NCT06626828
- Lead Sponsor
- Hong Kong Baptist University
- Brief Summary
Background:
Amnestic mild cognitive impairment (aMCI) is a prevalent condition, often regarded as the transitional phase between normal cognitive aging and early Alzheimer\'s disease. Conventional treatments for aMCI remain limited, with pharmacological interventions showing mixed results and often failing to halt disease progression. Electroacupuncture (EA), is believed to improve cognitive function in various neurodegenerative disorders, including aMCI. Randomized controlled trials have also reported that acupuncture can positively influence cognitive function by promoting cerebral blood flow and modulating neurotransmitter activity, potentially offering a non-pharmacological approach to managing aMCI. However, robust clinical trials are lacking, and there is a need to assess the feasibility and efficacy of EA in treating aMCI. This pilot study aims to determine the preliminary efficacy of EA in improving cognitive function, and to evaluate the feasibility of the study design for future large-scale trials.
Methods:
This trial will be a multicenter, assessor- and data analyst-blind, pilot randomized controlled trial. A total of 24 participants aged 55-75 years, diagnosed with aMCI, will be recruited and randomly assigned in a 1:1 ratio into either the EA treatment group or a control group. Participants in the EA group will receive electroacupuncture at specific acupoints, while the control group will not undergo any intervention. The intervention will last 4 weeks, with two EA sessions per week, a total of 8 sessions. Assessments will be conducted at three time points: baseline, post-treatment (Week 4), and follow-up (Week 6). All participants will continue their standard medical care throughout the trial.
The primary outcome will be the change in cognitive function as measured by the Hong Kong version of the Montreal Cognitive Assessment (HK-MoCA). Secondary outcomes will include changes in the Clinical Dementia Rating (CDR) and verbal fluency test, focusing on the memory domain. Safety and adverse events will be monitored throughout the study via follow-up assessments and questionnaires. Statistical analyses, including linear mixed models (LMM), will be performed using R and SPSS software, adhering to the intention-to-treat principle.
Expected Outcomes:
This pilot study is expected to provide preliminary data on the efficacy and safety of electroacupuncture in improving cognitive function in patients with aMCI. It will also assess the feasibility of conducting a larger-scale trial, including participant recruitment, adherence to the intervention, and the acceptability of outcome measures. Findings from this study will offer insights into the therapeutic potential of acupuncture and inform the design of future trials aimed at exploring its role as an alternative or complementary treatment for aMCI.
- Detailed Description
Ethical Considerations:
Ethical approval for this study has been obtained from the Research Ethics Committee of Hong Kong Baptist University (REC/23-24/0234). All participants will provide written informed consent before enrollment, and their confidentiality and safety will be prioritized throughout the study.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Diagnosed with an aMCI according to the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA)
- With a Clinical Dementia Scale (CDR) score of 0.5, with the memory domain larger than 0
- Within the age range of 55 to 75 years old
- With visual and auditory acuity adequate for neuropsychological testing
- Under a stable medical condition for 3 months prior to screening and baseline assessment
- Under stable medications for 4 weeks before screening and baseline assessment
- With concurrent conditions that could contribute to the cognitive deficits, including any type of dementia including Alzheimer disease, vascular dementia, or any major psychiatric disorders such as major depressive disorder, schizophrenia, delirium, psychosis, etc.
- With concurrent depression, anxiety, or suicidal thoughts within the past year
- With concurrent major neurological conditions, including stroke, epilepsy and seizures, etc.
- Currently immunocompromised due to receiving treatment for tumor, receiving immunosuppressive therapy, primary immunodeficiency, HIV infection, receiving high dose corticosteroids, etc
- With bleeding disorders, including hemophilia, von Willebrand disease, vitamin K deficiency, etc.
- With active neoplastic disease
- Currently pregnant
- Received acupuncture treatment for aMCI within a month before baseline assessment
- Experienced severe allergy after receiving acupuncture treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Electroacupuncture group Electroacupuncture After sterilization, disposable sterilized needles (0.25 × 40 mm, Taichi disposable acupuncture needles, Suzhou Shenlong Medical Apparatus Company, Suzhou, China) are inserted by the Registered Chinese Medicine Practitioner (RCMP) into the acupoints of Shenting (GV24), left Benshen (GB13), right Benshen (GB13), Baihui (GV20), and Sishencong (EX-HN 1). Acupoints are then stimulated by the Huatuo SDZ-II electroacupuncture device.
- Primary Outcome Measures
Name Time Method Domain and total score of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) adjusted by age and education level From baseline to Week 6 Comprehensively evaluates multiple cognitive domains, including memory recall, visuospatial ability, language, attention, concentration, executive function, and orientation to time and space. The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Scores are adjusted by age and education level. To mitigate the potential for practice effects, an alternate version of the HK-MoCA was employed during follow-up assessments.
- Secondary Outcome Measures
Name Time Method Total score and memory domain score of the Clinical Dementia Rating (CDR) Scale From baseline to Week 6 The CDR Scale is a widely recognized and validated instrument used to assess the severity and stage of dementia by evaluating six key cognitive domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. The overall CDR score ranges from 0 (normal cognition) to 3 (severe dementia), with higher scores indicating worse cognitive function. Specifically, a CDR score of 0.5 indicates mild cognitive impairment (MCI), while scores of 1, 2, and 3 reflect mild, moderate, and severe dementia, respectively. For this study, both the total score and the memory domain score were used to assess participants over time.
Verbal Fluency Test From baseline to Week 6 Verbal fluency was assessed by asking participants to recall as many words as possible within a specific semantic category in one minute, which serves as a measure of verbal executive function. For this study, animals and fruits were the categories used. The total number of words generated serves as the verbal fluency score, with higher scores indicating better verbal executive function. There is no predefined minimum or maximum for this test, but lower scores suggest impaired executive function and cognitive flexibility.
Trial Locations
- Locations (1)
Hong Kong Baptist University
🇭🇰Hong Kong, Hong Kong