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
CRIS Registration Number |
KCT0005070 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 2 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | The Catholic University of Pusan |
Organization Type | University |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | The Catholic University of Pusan |
Organization Type | University |
7. Study Summary
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. |
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8. Study Design
Study Type | Interventional Study |
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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
Condition(s)/Problem(s) |
Not Applicable-Etc
Healthy elderly |
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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. |
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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)
Type of Primary Outcome | Efficacy | |
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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
Result Registered |
Yes
Results Upload |
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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 Statement | No |
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