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

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

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 Overview

• Status: Unknown
• Conditions: Subjective Cognitive Decline; Subjective Cognitive Complaint
• Intervention / Treatment: Device: Acupuncture group; Device: Sham acupuncture group

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu c zhi, PHD; Phone Number: 010-53912201; Email: lcz623780@126.com
• Study Contact Backup: Name: Shi G xia, MD; Phone Number: 010-53912201; Email: shiguangxia2008@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
      • Contact: Cun-Zhi Liu, PHD; Phone Number: 010-52176043; Email: lcz623780@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture group	Device: Acupuncture group; 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.
Placebo Comparator: Sham acupuncture group	Device: Sham acupuncture group; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The degree of complaint in cognitive decline	measured by Subjective Cognitive Decline Questionnaire.	baseline and 12 weeks
The sleep quality	Measured by Pittsburgh Sleep Quality Index	baseline and 12 weeks
The depressive symptoms	Measured by Geriatric depression scale	baseline and 12 weeks
The face recognition ability and sense of direction	Measured by Face recognition questionnaire and Santa Barbara Sense of Direction scale	baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Beijing Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Yan CQ, Zhou P, Wang X, Tu JF, Hu SQ, Huo JW, Wang ZY, Shi GX, Zhang YN, Li JQ, Wang J, Liu CZ. Efficacy and neural mechanism of acupuncture treatment in older adults with subjective cognitive decline: study protocol for a randomised controlled clinical trial. BMJ Open. 2019 Oct 10;9(10):e028317. doi: 10.1136/bmjopen-2018-028317.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2018
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 2017BL-061-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No