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

Primary Purpose

Subjective Cognitive Decline, Subjective Cognitive Complaint

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture group
Sham acupuncture group
Sponsored by
Beijing Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Cognitive Decline

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acupuncture group

Sham acupuncture group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2018
Last Updated
June 13, 2019
Sponsor
Beijing Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03444896
Brief Title
The Efficacy and Mechanism of Acupuncture Treatment in Patients With Subjective Cognitive Decline
Official Title
The Efficacy and Neural Mechanism of Acupuncture Treatment in Older Adults With Subjective Cognitive Decline: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline, Subjective Cognitive Complaint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture group
Arm Type
Experimental
Arm Title
Sham acupuncture group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Acupuncture group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham acupuncture group
Intervention Description
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 Measure Information:
Title
Change in cognitive function
Description
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 Outcome Measure Information:
Title
Neuroplasticity outcome
Description
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
Other Pre-specified Outcome Measures:
Title
The degree of complaint in cognitive decline
Description
measured by Subjective Cognitive Decline Questionnaire.
Time Frame
baseline and 12 weeks
Title
The sleep quality
Description
Measured by Pittsburgh Sleep Quality Index
Time Frame
baseline and 12 weeks
Title
The depressive symptoms
Description
Measured by Geriatric depression scale
Time Frame
baseline and 12 weeks
Title
The face recognition ability and sense of direction
Description
Measured by Face recognition questionnaire and Santa Barbara Sense of Direction scale
Time Frame
baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female adults aged 55-75; Native Chinese speakers with right-handed and at least a primary school education; Self-reported persistent memory decline, which was confirmed by caregivers; 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); No or minimal impairment in activities of daily living; Exclusion Criteria: Presence of positive neurologic history (e.g., traumatic brain injury, stroke, Parkinson's disease, multiple sclerosis, etc.) ; treatments that would affect cognitive function; Presence of significant psychiatric history (e.g., bipolar disorder, schizophrenia, etc.) and/or severe anxiety and depression; Presence of serious heart, kidney, liver, gastrointestinal, infectious, endocrine disease or cancer; History of alcohol or drug abuse/addiction in nearly two years; Any contraindications for magnetic resonance imaging (MRI) scans (e.g., aneurysm clip pacemaker, etc.); Significant visual and/or auditory impairment uncorrected by aids, and unable to perform neuropsychological evaluations; Currently enrolled in another research study; Received acupuncture treatment in the preceding month.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu c zhi, PHD
Phone
010-53912201
Email
lcz623780@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shi G xia, MD
Phone
010-53912201
Email
shiguangxia2008@126.com
Facility Information:
Facility Name
School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cun-Zhi Liu, PHD
Phone
010-52176043
Email
lcz623780@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31601583
Citation
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.
Results Reference
derived

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

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