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Effect of Vagus Nerve Stimulation on Anti-Aging by Enhancing Antioxidant Capacity of the Elderly

Status Approved

  • First Submitted Date

    2020/02/18

  • Registered Date

    2020/05/29

  • Last Updated Date

    2020/05/29

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 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
    KCT0005070
    Unique Protocol ID CUPIRB-2017-038
    Public/Brief Title Effect of Vagus Nerve Stimulation on Anti-Aging by Enhancing Antioxidant Capacity of the Elderly
    Scientific Title Effect of Vagus Nerve Stimulation on Anti-Aging by Enhancing Antioxidant Capacity of the Elderly
    Acronym
    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 CUPIRB-2017-038
    Approval Date 2017-09-27
    Institutional Review Board Name Busan Catholic University Institutional Review Board
    Institutional Review Board Address 57, Oryundae-ro, Geumjeong-gu, Busan
    Institutional Review Board Telephone 051-510-0745
    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 Hyunju Moon
    Title researcher
    Telephone +82-55-333-6235
    Affiliation The Catholic University of Pusan
    Address # 1506-ho, 205-dong, 89, Gusan-ro 5 beon-gil, Gimhae-si, Gyeongnam
    Contact Person for Public Queries
    Name Hyunju Moon
    Title researcher
    Telephone +82-55-333-6235
    Affiliation The Catholic University of Pusan
    Address # 1506-ho, 205-dong, 89, Gusan-ro 5 beon-gil, Gimhae-si, Gyeongnam
    Contact Person for Updating Information
    Name Hyunju Moon
    Title researcher
    Telephone +82-55-333-6235
    Affiliation The Catholic University of Pusan
    Address # 1506-ho, 205-dong, 89, Gusan-ro 5 beon-gil, Gimhae-si, Gyeongnam
  • 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 Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2017-09-28 Actual
    Target Number of Participant 30
    Primary Completion Date 2017-11-30 , Actual
    Study Completion Date 2017-11-30 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kaya university
    Recruitment Status Completed
    Date of First Enrollment 2017-09-28 ,
    Recruitment Status by Participating Study Site 2
    Name of Study The Catholic University of Pusan
    Recruitment Status Completed
    Date of First Enrollment 2017-09-29 ,
  • 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 The Catholic University of Pusan
    Organization Type University
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name The Catholic University of Pusan
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Purpose: The purpose of this study was to investigate the effects of auricular vagus nerve electrical stimulation on blood lipid and systemic inflammation in the elderly.
    Subjects and Methods: Thirty elderly aged 70 or older were randomly assigned to the intervention group and the control group. The intervention group received electrical stimulation of the vagus nerve of the left ear cymba conche area and the intervention period was 30 minutes per day for 5 days per week for 4 weeks. The mean change of  total cholesterol (TC), low-density lipoprotein(LDL),high density lipoprotein(HDL),triglyceride(TG), and C-reactive protein(CRP) in the group according to the intervention was analyzed using the Wilcoxon signed-rank test, and the mean comparison difference between groups was analyzed by the Mann whitney-U test.
    Results: In the intervention group, the blood levels of TC, LDL and CRP were significantly decreased after 4 weeks of vagus nerve stimulation. TC, LDL, and CRP were significantly different between the two groups. However, there were no significant changes of blood lipid and CRP in the control group.
    Conclusion: Auricular vagus nerve electrical stimulation has been shown to reduce blood lipid and systemic inflammation levels in the elderly. These results suggest that electrical stimulation of the vagus nerves affects the lipid metabolism of the elderly and may reduce the systemic inflammation and may help the cardiovascular health of the elderly.
  • 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
    Others
    (The purpose of this study was to investigate the effects of Auricular vagus nerve electrical stimulation on blood lipids and systemic inflammation in the elderly.)
    Phase Not applicable
    Intervention Model Others (Electric nerve stimulation of the Vagus nerve five times a week for two weeks)
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device, Others (Low frequency electric stimulator)
    Intervention Description
    One week before intervention, blood samples were collected for analysis of plasma TC, LDL, HDL, TG, and CRP levels, and intervention was applied for 4 weeks. To exclude the researcher's prejudice, the application of the intervention and the analysis of the serum were commissioned to the third expert.
    The intervention was performed vagus nerve electrical stimulation in the left ear cymba conche area of the subjects of the intervention group for 30 minutes, 5 days, 4 weeks. The subjects in the control group did not apply any intervention, but maintained the same diet and lifestyle as before the experiment. After 4 weeks of intervention, subjects were sampled for analysis of serum TC, LDL, HDL, TG, and CRP levels, and the mean values before and after intervention were analyzed and compared.When the vagus nerve stimulation was applied to the ear area, the subjects were laid sideways with their left ears visible. The left ear of the subject was wiped with alcohol cotton and a 4 cm long needle was inserted into the cymba conche area. After that, the clamping electrodes of the electric needle stimulator (STN-330, Stratek, Korea) were connected to the needles and electric current was applied. The current was applied at a low frequency of 20 Hz, pulse duration of 200 μs, and a current intensity of 5 mA. After 30 minutes, the electrode needle was removed, and the ear was wiped with alcohol cotton wool.
    For the placebo stimulation of the control group, the subject was placed on the side with the left ear visible, and then a forceps-type electrode of an electric needle stimulator (STN-330, Stratek, Korea) was connected to the lobulus region of the left ear, and no current was applied.
    Number of Arms 2
    Arm 1

    Arm Label

    Vagus Nerve Stimulation Group

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    When the vagus nerve stimulation was applied to the ear area, the subjects were laid sideways with their left ears visible. The left ear of the subject was wiped with alcohol cotton and a 4 cm long needle was inserted into the cymba conche area. After that, the clamping electrodes of the electric needle stimulator (STN-330, Stratek, Korea) were connected to the needles and electric current was applied. The current was applied at a low frequency of 20 Hz, pulse duration of 200 μs, and a current intensity of 5 mA. After 30 minutes, the electrode needle was removed, and the ear was wiped with alcohol cotton wool.
    Arm 2

    Arm Label

    control group

    Target Number of Participant

    15

    Arm Type

    Placebo comparator

    Arm Description

    One week before intervention, blood samples were collected for analysis of plasma TC, LDL, HDL, TG, and CRP levels, and intervention was applied for 4 weeks. The control group connected only the electrodes without current to the lobulus region of the left ear for 4 weeks.After the intervention, blood samples were collected to analyze the blood TC, LDL, HDL, TG, and CRP levels of all subjects.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s)    Not Applicable-Etc 

    Healthy elderly
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    70Year~79Year

    Description

    The criteria for the selection of the subjects were as follows: Mini mental state evaluation(MMSE) score of 25 or more, Less than 10 points in geriatric depression scale(GDS), Those who did not have any specific disease as a result of the medical examination within 6 months, and did not take inflammatory drugs such as anti-inflammatory drugs and antibiotics at present.
    Exclusion Criteria
    Eligibility criteria are as follows.
    People with specific diseases such as cognitive defects, depressed emotions, and cancer, and those taking medications excluding blood pressure medication
    Healthy Volunteers Yes
  • 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
    Changes in blood lipids and inflammatory protein levels according to intervention
    Timepoint
    before and after intervention
    Secondary Outcome(s) 1
    Outcome
    TC,LDL,HDL,TG,CRP
    Timepoint
    before and after 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 Yes
    Results Upload
    Final Enrollment Number 30
    Number of Publication 0
    Results Upload Auricular vagus nerve electrical stimulation.docx
    Date of Posting Results 2020/05/29
    Protocol URL or File Upload
    Brief Summary
    1. General characteristics of subjects 
    There was no significant difference in the general characteristics of the two groups.
    2. Changes in blood lipids and inflammatory protein levels in the group 
    In the intervention group, the levels of TC, LDL, and CRP were significantly decreased after auricular vagus nerve electrical stimulation, and there was no significant change in any variables in the control group. 
    3. Changes in blood lipids and inflammatory proteins between groups 
    After the intervention, the changes of TC, LDL, HDL, TG, and CRP between groups were compared and the TC, LDL and CRP levels in the intervention group were significantly decreased.
    
  • 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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