Charlestown, Massachusetts 02129

  • Major Depressive Disorder

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.


Study summary:

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.


Criteria:

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 is Available At:


Original ID:

2019P003698


NCT ID:

NCT04607226


Secondary ID:

26236


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Female


Minimum Age:

24 Years


Maximum Age:

45 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Massachusetts General Hospital


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Ronald G Garcia, MD, PhD
Principal Investigator
Massachusetts General Hospital
Primary Contact:Ronald G Garcia, MD, PhD
617-643-4265
rgarciagomez@mgh.harvard.edu
Backup Contact:Colleen Sheller, BS
617-726-9725
csheller@mgh.harvard.edu

Study Dates

Start Date:November 2, 2020
Completion Date:January 14, 2023
Completion Type:Anticipated
Primary Completion Date:January 14, 2023
Primary Completion Type:Anticipated
Verification Date:March 2022
Last Changed Date:March 9, 2022
First Received Date:October 22, 2020

Study Outcomes

Outcome Type:Primary Outcome
Measure:Cardiac autonomic function
Time Frame:1 hour
Safety Issues:False
Description:Changes in cardiac autonomic function (High Frequency power-Heart Rate Variability) between active and sham tVNS.
Outcome Type:Primary Outcome
Measure:Change in depressive symptoms assessed by the Beck Depression Inventory
Time Frame:1 hour
Safety Issues:False
Description: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 symp
Outcome Type:Secondary Outcome
Measure:Change in serum levels of pro-inflammatory cytokines
Time Frame:2 hours
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Other
Name:Sham transcutaneous vagus nerve stimulation
Description:stimulation of the auricle for 30 minutes
Arm Name:Sham tVNS
Other Name:transcutaneous vagus nerve stimulation
Intervention Type:Other
Name:Active transcutaneous vagus nerve stimulation
Description:respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
Arm Name:Active tVNS - 100 Hz
Other Name:Respiratory-gated Auricular Vagal Afferent Nerve S

Study Arms

Study Arm Type:Sham Comparator
Arm Name:Sham tVNS
Description:Sham transcutaneous vagus nerve stimulation on the left auricle
Study Arm Type:Experimental
Arm Name:Active tVNS - 100 Hz
Description:Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 100 Hz stimulation frequency
Study Arm Type:Experimental
Arm Name:Active tVNS - 30 Hz
Description:Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 30 Hz stimulation frequency
Study Arm Type:Experimental
Arm Name:Active tVNS - 8 Hz
Description:Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 8 Hz stimulation frequency
Study Arm Type:Experimental
Arm Name:Active tVNS - 2 Hz
Description:Expiratory-gated transcutaneous vagus nerve stimulation on the left auricle with 2 Hz stimulation frequency

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Massachusetts General Hospital
Agency Class:Other
Agency Type:Collaborator
Agency Name:Brain & Behavior Research Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: August 16, 2022

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.