Skip to content

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

Xidian University,China

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03592446
Enrollment
60
Registered
2018-07-19
Start date
2018-09-01
Completion date
2020-07-30
Last updated
2018-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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.

Interventions

All subjects receive electrical stimulation at earlobe.

All subjects receive electrical VNS stimulation at cymba conchae.

Sponsors

Xidian University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
actual neural activation in brain2 hoursBy using fMRI technology, the BOLD signal of brain is analyzed.

Secondary

MeasureTime frameDescription
Heart rate variability2 hoursFrequency 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.

Contacts

Primary Contactxuejuan Yang
xjyang@xidian.edu.cn86-029-81891070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026