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

Beijing Hospital of Traditional Chinese Medicine60 enrolled

Overview

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Subjective Cognitive Decline Subjective Cognitive Complaint

Interventions

Acupuncture groupDEVICE

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.

Sham acupuncture groupDEVICE

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female adults aged 55-75; 2. Native Chinese speakers with right-handed and at least a primary school education; 3. Self-reported persistent memory decline, which was confirmed by caregivers; 4. 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); 5. No or minimal impairment in activities of daily living; Exclusion Criteria: 1. Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ; 2. treatments that would affect cognitive function; 3. Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression; 4. Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer; 5. History of alcohol or drug abuse/addiction in nearly two years; 6. Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.); 7. Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations; 8. Currently enrolled in another research study; 9. Received acupuncture treatment in the preceding month.

Locations (1)

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Changes from baseline at 12 weeks

Secondary Outcomes

Neuroplasticity outcome

Neuroplasticity outcome changes are measured by structural MRI (including DTI), task functional MRI, resting state functional MRI and arterial spin labeling.

Time frame: baseline and 12 weeks

Central Contacts

Liu c zhi, PHD

CONTACT

010-53912201 lcz623780@126.com

Shi G xia, MD

CONTACT

010-53912201 shiguangxia2008@126.com

Data from ClinicalTrials.gov

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