NCT03592446

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

July 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1.9 years

First QC Date

June 26, 2018

Last Update Submit

July 9, 2018

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

  • actual neural activation in brain

    By using fMRI technology, the BOLD signal of brain is analyzed.

    2 hours

Secondary Outcomes (1)

  • Heart rate variability

    2 hours

Study Arms (2)

Active-raVNS

EXPERIMENTAL

Transcutaneous electrical vagus nerve stimulation at ear.

Device: Transcutaneous electrical vagus nerve stimulation

Sham-raVNS

SHAM COMPARATOR

Sham vagus nerve stimulation at ear.

Device: Sham vagus nerve stimulation

Interventions

Transcutaneous electrical vagus nerve stimulationDEVICE

All subjects receive electrical VNS stimulation at cymba conchae.

Active-raVNS
Sham vagus nerve stimulationDEVICE

All subjects receive electrical stimulation at earlobe.

Sham-raVNS

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

xuejuan Yang

CONTACT

86-029-81891070xjyang@xidian.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 19, 2018

Study Start

September 1, 2018

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

July 19, 2018

Record last verified: 2018-06