연구정보 영문

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

Status Approved

  • First Submitted Date

    2018/12/01

  • Registered Date

    2019/01/16

  • Last Updated Date

    2020/08/25

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003430
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific 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 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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Ministry of Education
    Organization Type Government
    Project ID 2018R1D1A1B07045343
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dongshin University
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    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

    Subject Eligibility Information
    Condition(s)/Problem(s) * (F00-F99)Mental and behavioural disorders 
       (F06.7)Mild cognitive disorder 

    mild cognitive impairment
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    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

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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