Back to resultsNeural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients
Primary Purpose
Depression
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcutaneous electrical vagus nerve stimulation
Sham vagus nerve stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Meets ICD-10 diagnosis standard;
- without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
- Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.
Exclusion Criteria:
- With current addiction to drugs;
- With other severe organic diseases, such as severe heart disease, kidney failure etc;
- disagree with the consent form.
- Cannot receive MRI scan.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active-raVNS
Sham-raVNS
Arm Description
Transcutaneous electrical vagus nerve stimulation at ear.
Sham vagus nerve stimulation at ear.
Outcomes
Primary Outcome Measures
actual neural activation in brain
By using fMRI technology, the BOLD signal of brain is analyzed.
Secondary Outcome Measures
Heart rate variability
Frequency domain methods is used to analyze the bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03592446
Brief Title
Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients
Official Title
Xidian University,China
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
July 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xidian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Electrical vagus nerve stimulation (VNS) was approved by FDA for treatment of chronic recurrent depression in 2005. Recently, non-invasive, transcutaneous auricular vagus nerve stimulation （taVNS） has already been used for depression treatment. However, the neural mechanism remains unclear, and the relationship between stimulation parameters and neural response were also unknown. The present study aims to investigate the specific brain activation in depression patients after taVNS，compared with healthy controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active-raVNS
Arm Type
Experimental
Arm Description
Transcutaneous electrical vagus nerve stimulation at ear.
Arm Title
Sham-raVNS
Arm Type
Sham Comparator
Arm Description
Sham vagus nerve stimulation at ear.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical vagus nerve stimulation
Intervention Description
All subjects receive electrical VNS stimulation at cymba conchae.
Intervention Type
Device
Intervention Name(s)
Sham vagus nerve stimulation
Intervention Description
All subjects receive electrical stimulation at earlobe.
Primary Outcome Measure Information:
Title
actual neural activation in brain
Description
By using fMRI technology, the BOLD signal of brain is analyzed.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Heart rate variability
Description
Frequency domain methods is used to analyze the bands of frequency and then count the number of NN intervals that match each band. The bands are typically high frequency (HF) from 0.15 to 0.4 Hz, low frequency (LF) from 0.04 to 0.15 Hz, and the very low frequency (VLF) from 0.0033 to 0.04 Hz.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Meets ICD-10 diagnosis standard;
without taking anti-depressive medication or other psychiatric medications 2 weeks before the experiment;
Patient has exhibited symptoms for at least 2 months, but no longer than 2 years.
Exclusion Criteria:
With current addiction to drugs;
With other severe organic diseases, such as severe heart disease, kidney failure etc;
disagree with the consent form.
Cannot receive MRI scan.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuejuan Yang
Phone
86-029-81891070
Email
xjyang@xidian.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients
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