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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03444896
Recruitment Status : Recruiting
First Posted : February 26, 2018
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ping Zhou, Beijing Hospital of Traditional Chinese Medicine

Brief 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 .

Condition or disease Intervention/treatment Phase
Subjective Cognitive Decline Subjective Cognitive Complaint Device: Acupuncture group Device: Sham acupuncture group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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.




Primary Outcome Measures :
  1. Change in cognitive function [ Time Frame: Changes from baseline at 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Neuroplasticity outcome [ Time Frame: baseline and 12 weeks ]
    Neuroplasticity outcome changes are measured by structural MRI (including DTI), task functional MRI, resting state functional MRI and arterial spin labeling.


Other Outcome Measures:
  1. The degree of complaint in cognitive decline [ Time Frame: baseline and 12 weeks ]
    measured by Subjective Cognitive Decline Questionnaire.

  2. The sleep quality [ Time Frame: baseline and 12 weeks ]
    Measured by Pittsburgh Sleep Quality Index

  3. The depressive symptoms [ Time Frame: baseline and 12 weeks ]
    Measured by Geriatric depression scale

  4. The face recognition ability and sense of direction [ Time Frame: baseline and 12 weeks ]
    Measured by Face recognition questionnaire and Santa Barbara Sense of Direction scale



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444896


Contacts
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Contact: Liu c zhi, PHD 010-53912201 lcz623780@126.com
Contact: Shi G xia, MD 010-53912201 shiguangxia2008@126.com

Locations
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China, Beijing
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine Recruiting
Beijing, Beijing, China, 100029
Contact: Cun-Zhi Liu, PHD    010-52176043    lcz623780@126.com   
Sponsors and Collaborators
Beijing Hospital of Traditional Chinese Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ping Zhou, doctor, Beijing Hospital of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03444896    
Other Study ID Numbers: 2017BL-061-03
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders