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

Xidian University

Status: Unknown

Conditions: Depression

Treatments: Device: Sham vagus nerve stimulation; Device: Transcutaneous electrical vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03592446

81471812

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Active-raVNS

Experimental group

Description:

Transcutaneous electrical vagus nerve stimulation at ear.

Treatment:

Device: Transcutaneous electrical vagus nerve stimulation

Sham-raVNS

Sham Comparator group

Description:

Sham vagus nerve stimulation at ear.

Treatment:

Device: Sham vagus nerve stimulation