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

Subjective Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444896
• Other study ID #: 2017BL-061-03
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Complaint
• Subjective Cognitive Decline

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