Purpose

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.

Condition

Eligibility

Eligible Ages
Between 24 Years and 45 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosis of recurrent Major Depressive Disorder with a current active depressive episode - Currently not taking psychiatric medications or on a stable therapeutic dose of psychiatric medication for at least 30 days prior to entering the study

Exclusion Criteria

  • History of cardio-, cerebro-, or peripheral vascular disease, diabetes mellitus, morbid obesity (BMI > 40 kg/m2), kidney or liver failure, history of unexplained fainting spells - Any psychiatric disorder involving a history of psychosis (e.g. schizophrenia, bipolar disorders, severe personality disorders) - Any chronic condition affecting movement, speech and/or ability to read or follow written instructions - Substance use disorder, either mild, moderate, or severe within the past 12 months (excludes nicotine) - History of suicide attempt within the last year or current active suicidal ideation - History of a clinically defined neurological disorder including, but not limited to: Any condition likely to be associated with increased intracranial pressure; space occupying brain lesion; History of cerebrovascular accident; Transient ischemic attack within two years; Cerebral aneurysm; Dementia; Parkinson's Disease; Huntington's chorea; or Multiple sclerosis. - Pregnant or nursing - Metallic implants or devices contraindicating tVNS

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active tVNS - 2 Hz
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 2 Hz stimulation frequency
  • Other: Active transcutaneous vagus nerve stimulation
    respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
    Other names:
    • Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS)
    • transcutaneous vagus nerve stimulation
Experimental
Active tVNS - 8 Hz
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 8 Hz stimulation frequency
  • Other: Active transcutaneous vagus nerve stimulation
    respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
    Other names:
    • Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS)
    • transcutaneous vagus nerve stimulation
Experimental
Active tVNS - 30 Hz
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 30 Hz stimulation frequency
  • Other: Active transcutaneous vagus nerve stimulation
    respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
    Other names:
    • Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS)
    • transcutaneous vagus nerve stimulation
Experimental
Active tVNS - 100 Hz
Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 100 Hz stimulation frequency
  • Other: Active transcutaneous vagus nerve stimulation
    respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
    Other names:
    • Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS)
    • transcutaneous vagus nerve stimulation
Sham Comparator
Sham tVNS
Sham transcutaneous vagus nerve stimulation on the left auricle
  • Other: Sham transcutaneous vagus nerve stimulation
    stimulation of the auricle for 30 minutes
    Other names:
    • transcutaneous vagus nerve stimulation

Recruiting Locations

Massachusetts General Hospital
Charlestown, Massachusetts 02129
Contact:
Ronald G Garcia, MD, PhD
617-643-4265
rgarciagomez@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Ronald G Garcia, MD, PhD
617-643-4265
rgarciagomez@mgh.harvard.edu

Detailed Description

This study will compare the acute effects of respiratory-gated transcutaneous vagus nerve stimulation (tVNS) at different stimulation frequencies and sham stimulation during five sessions within a 2 week period. Heart rate variability (HRV) point process adaptive filtering estimation algorithms will be used to evaluate changes in cardiac autonomic physiology in subjects with major depression in response to tVNS. The effects of tVNS on cardiovagal regulation will be evaluated at rest and in response to an emotion reactivity task. Depression rating scales (Beck's Depression Inventory) will be used to evaluate short term effects of tVNS on depressive symptoms in these subjects. In addition, the study will evaluate the acute effects of the stimulation on serum levels of pro-inflammatory cytokines. The stimulation frequency that produces the greatest regulatory effects on depressive symptoms and physiological variables in this population will be used in a second longitudinal phase of the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.