The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline

Study Overview
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Brief Summary
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This study evaluates the efficacy and mechanism of acupuncture treatment in patients with subjective cognitive decline. Half of patients will receive acupuncture treatment for 12 weeks, while the other half will receive sham acupuncture treatment for 12 weeks .

Official Title
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The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial

Conditions
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Subjective Cognitive Decline, Subjective Cognitive Complaint

Intervention / Treatment
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* Device: Acupuncture group
* Device: Sham acupuncture group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 55-75; Native Chinese speakers with right-handed and at least a primary school education; Self-reported persistent memory decline, which was confirmed by caregivers; Normal general cognitive function and not meeting the criterion of mild cognitive impairment, as defined by performance within the normal range on both measures within at least one cognitive domain or in each of the three cognitive domains sampled (adjusted for age and education); No or minimal impairment in activities of daily living; Exclusion Criteria: Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ; treatments that would affect cognitive function; Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression; Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer; History of alcohol or drug abuse/addiction in nearly two years; Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.); Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations; Currently enrolled in another research study; Received acupuncture treatment in the preceding month.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture group<br> | Device: Acupuncture group<br>* Acupuncture needles were placed at acupoints Baihui (DU20), Shenting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Yixi (BL45), Tongli (HT5), and Zhaohai(KI6). Electrodes were attached the needle holders of the Baihui (DU20) and Shenting (DU24). The acupuncture needles are inserted through the adhesive pads and are retained for 20 minutes in every course. Treatment will be conducted over a period of 3 months, at a frequency of two times per week.<br>|
| Placebo Comparator: Sham acupuncture group<br> | Device: Sham acupuncture group<br>* Sham acupoint (SA) 1 located in the midpoint of Shuaigu and Touwei. SA2 located in the midpoint of Touwei and Yangbai. SA3 located in the midpoint of Tianyou and Tianrong. SA4 located in 4 cun above umbilicus and 1 cun right of umbilical midline (UM). SA5 located in 2 cun below umbilicus and 1 cun right of UM. SA6 1 cun outside the point 1/4 of the line between Shenmen and Shaohai. SA7 located in 1 cun outside the midpoint of Shaohai and Tongli. SA8 located in 6 cun above mediosuperior border of the patella. SA9 located in 3 cun below the Yanglingquan and middle of the gallbladder and bladder channels. SA10 located in midpoint between Jiexi and Qiuxu. SA11 and SA12 located in 2 cun from the lower border of spinous process of fifth or sixth thoracic vertebra. Electrodes were attached the needle holders of the bilateral SA 2. Procedures, and other treatment settings were the same in the acupuncture group but with no skin penetration, electricity output, or needle manipulation for de qi.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognitive function | A composite score will be computed by averaging z-scores from Animal Fluency Test, Digit Symbol Substitution Test, Trail-Making Test Parts A and B, Stroop Color Word Test C, Digit Span Test, Boston Naming Test, Clock Drawing Test and Auditory Verbal Learning Test delayed recall and delayed recognition. | Changes from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroplasticity outcome | Neuroplasticity outcome changes are measured by structural MRI (including DTI), task functional MRI, resting state functional MRI and arterial spin labeling. | baseline and 12 weeks |