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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03444896
Other study ID # 2017BL-061-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2018
Est. completion date March 2020

Study information

Verified date June 2019
Source Beijing Hospital of Traditional Chinese Medicine
Contact Liu c zhi, PHD
Phone 010-53912201
Email lcz623780@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date March 2020
Est. primary completion date January 2020
Accepts healthy volunteers No
Gender All
Age group 55 Years to 75 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
China School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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