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
|Condition or disease||Intervention/treatment||Phase|
|Subjective Cognitive Decline Subjective Cognitive Complaint||Device: Acupuncture group Device: Sham acupuncture group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|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.
- 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.
- 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.
- The degree of complaint in cognitive decline [ Time Frame: baseline and 12 weeks ]measured by Subjective Cognitive Decline Questionnaire.
- The sleep quality [ Time Frame: baseline and 12 weeks ]Measured by Pittsburgh Sleep Quality Index
- The depressive symptoms [ Time Frame: baseline and 12 weeks ]Measured by Geriatric depression scale
- 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
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
|Contact: Liu c zhi, PHDemail@example.com|
|Contact: Shi G xia, MDfirstname.lastname@example.org|
|School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Cun-Zhi Liu, PHD 010-52176043 email@example.com|