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

NCT04607226 | Completed

• 2 other identifiers: 2019P00369826236
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Major Depressive Disorder

Keywords

Transcutaneous Vagus Nerve Stimulation; Cardiac autonomic function; Depressive symptomatology

Outcome Measures

Primary Outcomes (2)

• Cardiac autonomic function

  Changes in cardiac autonomic function (High Frequency power-Heart Rate Variability) between active and sham tVNS.

  1 hour

• Change in depressive symptoms assessed by the Beck Depression Inventory

  Changes from baseline to post-stimulation in the score of the Beck Depression Inventory will be compared between active and sham tVNS. (Beck depression inventory minimum score= 0, maximum score= 63; higher total scores indicate more severe depressive symptoms)

  1 hour

Secondary Outcomes (1)

• Change in serum levels of pro-inflammatory cytokines

  2 hours

Study Arms (5)

Active tVNS - 2 Hz

EXPERIMENTAL

Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 2 Hz stimulation frequency

Other: Active transcutaneous vagus nerve stimulation

Active tVNS - 8 Hz

EXPERIMENTAL

Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 8 Hz stimulation frequency

Other: Active transcutaneous vagus nerve stimulation

Active tVNS - 30 Hz

EXPERIMENTAL

Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 30 Hz stimulation frequency

Other: Active transcutaneous vagus nerve stimulation

Active tVNS - 100 Hz

EXPERIMENTAL

Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 100 Hz stimulation frequency

Other: Active transcutaneous vagus nerve stimulation

Sham tVNS

SHAM COMPARATOR

Sham transcutaneous vagus nerve stimulation on the left auricle

Other: Sham transcutaneous vagus nerve stimulation

Interventions

Active transcutaneous vagus nerve stimulation OTHER

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

Also known as: Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS), transcutaneous vagus nerve stimulation

Active tVNS - 100 Hz; Active tVNS - 2 Hz; Active tVNS - 30 Hz; Active tVNS - 8 Hz

Sham transcutaneous vagus nerve stimulation OTHER

stimulation of the auricle for 30 minutes

Also known as: transcutaneous vagus nerve stimulation

Sham tVNS

Eligibility Criteria

• Age: 24 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Ronald G Garcia, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 29, 2020
• Study Start: November 2, 2020
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)