Status Approved
First Submitted Date
2018/12/01
Registered Date
2019/01/16
Last Updated Date
2020/08/25
1. Background
CRIS Registration Number |
KCT0003430 |
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Unique Protocol ID | DSGOH-051 |
Public/Brief Title | A clinical trial to investigate the different efficacy according to acupuncture treatment method on mild cognitive impairment |
Scientific Title | A randomized, outcome assessor blinded, parallel- arm, single center investigator initiated trial to investigate the different efficacy according to acupuncture treatment method on mild cognitive impairment |
Acronym | DSACU |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | DSGOH-051 |
Approval Date | 2018-09-17 |
Institutional Review Board Name | Institutional Review Board of DongShin University Gwangju Korean Medicine Hospital |
Institutional Review Board Address | 141, Wolsan-ro, Nam-gu, Gwangju |
Institutional Review Board Telephone | 062-350-7115 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Jae Hong Kim |
Title | associate professor |
Telephone | +82-62-350-7209 |
Affiliation | Dongshin University |
Address | Dongshin University Gwangju Korean Medicine Hospital, 141, Wolsan-ro Nam-gu Gwangju Republic of Korea |
Contact Person for Public Queries | |
Name | Jae Hong Kim |
Title | associate professor |
Telephone | +82-62-350-7209 |
Affiliation | Dongshin University |
Address | Dongshin University Gwangju Korean Medicine Hospital, 141, Wolsan-ro Nam-gu Gwangju Republic of Korea |
Contact Person for Updating Information | |
Name | Jae Hong Kim |
Title | associate professor |
Telephone | +82-62-350-7209 |
Affiliation | Dongshin University |
Address | Dongshin University Gwangju Korean Medicine Hospital, 141, Wolsan-ro Nam-gu Gwangju Republic of Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2019-02-25 Actual | |
Target Number of Participant | 32 | |
Primary Completion Date | 2020-05-26 , Actual | |
Study Completion Date | 2020-05-26 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Dongshin University Gwangju Oriental Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2019-02-25 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Ministry of Education |
Organization Type | Government |
Project ID | 2018R1D1A1B07045343 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Dongshin University |
Organization Type | University |
7. Study Summary
Lay Summary | Background:Mild cognitive impairment(MCI) is the clinical stage of cognition impairment between normal aging and Alzheimer’s disease(AD). It is important to find early and available interventions to delay the development from MCI to AD. Acupuncture has been reported to be effective in several studies on MCI. The effect of acupuncture treatment is influenced by factors such as needling sensation, psychological factors, acupoint specificity, acupuncture manipulation, and needle duration. The aim of this study is to investigate the best acupuncture treatment methods for MCI. Methods/Design: This study is a prospective, outcome assessor-blinded, parallel-arm, randomized, controlled single center(DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), clinical trial with a 1:1:1:1allocation ratio. Participants(n=32) with MCI will be randomly assigned to basic method group(n=8), acupoint specificity group(n=8), needle duration group(n=8), or electroacupuncture group(n=8). Acupuncture is administered once per day, 3 days per week (excluding Saturday and Sunday) for 8 weeks. The basic method group will receive acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 30 minutes. The acupoint specificity group will receive acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), Shenting(GV24), and Taixi(KI3) for 30 minutes. The needle duration group will receive acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 20 minutes. The electroacupuncture group will receive electroacupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 30 minutes. The primary outcome will be improvement of cognitive function assessed according to Korean version of Alzheimer’s Disease Assessment Scale – cognitive subscale(ADAS-K-cog), while Korean version of the Montreal Cognitive Assessment(MoCA-K), Center for Epidemiological Studies-Depression Scale(CES-D) Korean Activities of Daily Living(K-ADL), Korean Instrumental Activities of Daily Living(K-IADL), and European Quality of Life Five Dimension-Five Level Scale(EQ-5D-5L) score will be considered as secondary outcome measures. ADAS-K-cog, MoCA-K, CES-D, K-ADL, K-IADL, and EQ-5D-5L measurements will be performed at baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Treatment |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Single |
Blinded Subject | Subject |
Allocation | RCT |
Intervention Type | Medical Device |
Intervention Description | different acupuncture treatment once per day, 3 days per week (excluding Saturday and Sunday) for 8 weeks Basic methodgroup : acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. acupoint specificity group : acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), Shenting(GV24), Taixi(KI3) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. needle duration group : acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 20 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. electroacupuncture group : electroacupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), Shenting(GV24), Taixi(KI3) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. |
Number of Arms | 4 |
Arm 1 |
Arm Label Basic method group |
Target Number of Participant 8 |
|
Arm Type Active comparator |
|
Arm Description acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. |
|
Arm 2 |
Arm Label acupoint specificity group |
Target Number of Participant 8 |
|
Arm Type Experimental |
|
Arm Description acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), Shenting(GV24), Taixi(KI3) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. |
|
Arm 3 |
Arm Label needle duration group |
Target Number of Participant 8 |
|
Arm Type Experimental |
|
Arm Description acupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), and Shenting(GV24) for 20 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. |
|
Arm 4 |
Arm Label electroacupuncture group |
Target Number of Participant 8 |
|
Arm Type Experimental |
|
Arm Description electroacupuncture treatment at Baihui(GV20), Sishencong(EX-HN1), Fengchi(GB20), Shenting(GV24) for 30 minutes once per day, 3 days per week (excluding Saturdayand Sunday) for 8 weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (F00-F99)Mental and behavioural disorders (F06.7)Mild cognitive disorder mild cognitive impairment |
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Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 55Year~85Year |
|
Description Participants meeting all of the following criteria will be included in this trial. The inclusion criteria are as follows: 1) participants(males and females) aged 55 to 85 ; 2) participants who meet the Peterson diagnostic criteria for MCI, with memory impairments for at least 3 months; 3) Score in K-MMSE was 20-23; 4) Score in MoCA-K was 0-22;5) fluency in language sufficient to reliably complete all study assessment; 6) voluntarily signed the informed consent form. |
|
Exclusion Criteria |
Participants with a poor general condition and those who are not fit for electroacupuncture will be excluded. The exclusion criteria are as follows: 1) diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders- Ⅳ; 2) history of brain structure lesions which may cause cognitive impairment(e.g., traumatic brain injury, stroke, intracranial space-occupying lesions, congenital mental retardation); 3) complicated by cancer and serious diseases of the cardiovascular, cerobrovascular, liver, and kidney; 4) who had been treated with alcohol or drug dependency, mental diseases(e.g., schizophrenia, serious anxiety, and depression) in the past six months in the past six months; 5) Currently under treatment for MCI(e.g., medication, acupuncture, and cognitive training); 6) who have difficulties in assessment due to visual and hearing impairments; 7) who are not fit for electroacupuncture (e.g., blood clotting abnormalitiessuch as hemophilia, infection of the head skin, and pacemaker attached); 8) concurrent participation in other clinical trials |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Alzheimer's Disease Asessment Scale-Korean version-cognitive subscale (ADAS-K-cog) |
|
Timepoint | baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention |
|
Secondary Outcome(s) 1 | ||
Outcome | Korean version of the Montreal Cognitive Assessment(MoCA-K) |
|
Timepoint | baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention |
|
Secondary Outcome(s) 2 | ||
Outcome | Center for Epidemiological Studies-Depression Scale( CES-D) |
|
Timepoint | baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention |
|
Secondary Outcome(s) 3 | ||
Outcome | Korean Activities of Daily Living( K-ADL), Korean Instrumental Activities of Daily Living( K-IADL) |
|
Timepoint | baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention |
|
Secondary Outcome(s) 4 | ||
Outcome | European Quality of Life Five Dimension. Five Level Scale(EQ-5D-5L) |
|
Timepoint | baseline(before intervention), 8 weeks after the first intervention(i.e., at the end of intervention), and 12 weeks after the completion of intervention |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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