Neural Alteration Response to Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Depressed Patients

NCT ID: NCT03592446

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2020-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Active-raVNS

Transcutaneous electrical vagus nerve stimulation at ear.

Group Type EXPERIMENTAL

Transcutaneous electrical vagus nerve stimulation

Intervention Type DEVICE

All subjects receive electrical VNS stimulation at cymba conchae.

Sham-raVNS

Sham vagus nerve stimulation at ear.

Group Type SHAM_COMPARATOR

Sham vagus nerve stimulation

Intervention Type DEVICE

All subjects receive electrical stimulation at earlobe.

Interventions

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Transcutaneous electrical vagus nerve stimulation

All subjects receive electrical VNS stimulation at cymba conchae.

Intervention Type DEVICE

Sham vagus nerve stimulation

All subjects receive electrical stimulation at earlobe.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xidian University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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xuejuan Yang

Role: CONTACT

86-029-81891070

Other Identifiers

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81471812

Identifier Type: -

Identifier Source: org_study_id

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