Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)

NCT04607226 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-01

No results posted yet for this study

Summary

This study will evaluate the short term effects of respiratory-gated transcutaneous vagus nerve stimulation on the regulation of cardiovagal activity, depressive symptomatology and immune function in subjects with major depression and determine the optimal stimulation frequency for this population.

Conditions

Interventions

OTHER

Active transcutaneous vagus nerve stimulation

respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes

OTHER

Sham transcutaneous vagus nerve stimulation

stimulation of the auricle for 30 minutes

Sponsors & Collaborators

  • Brain & Behavior Research Foundation

    collaborator OTHER
  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Ronald G Garcia, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
24 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-10-12
Completion
2022-10-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04607226 on ClinicalTrials.gov