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

Major Depressive Disorder Clinical Trial

Official title:

A Translational Approach to Cardiorespiratory-Gated Stimulation of the Auricular Branch of the Vagus Nerve for the Treatment of Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607226
• Other study ID #: 2019P003698
• Secondary ID: 26236
• Status: Completed
• Phase: N/A
• Start date: November 2, 2020
• Est. completion date: October 12, 2022

Study information

• Verified date: July 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 24 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Other:
• Active transcutaneous vagus nerve stimulation
respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
• Sham transcutaneous vagus nerve stimulation
stimulation of the auricle for 30 minutes

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac autonomic function	Changes in cardiac autonomic function (High Frequency power-Heart Rate Variability) between active and sham tVNS.	1 hour
Primary	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	Change in serum levels of pro-inflammatory cytokines	Changes in serum levels of proinflammatory cytokines (Interleukin 1B, Interleukin 6, Tumor necrosis factor alfa) from baseline to post-stimulation will be assessed and compared between active and sham tVNS	2 hours