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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-02

Study Completion Date

2022-10-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vagus Nerve Stimulation: Integration of Behavior and Cardiac Modulation

NCT04467164

Major Depressive Disorder

COMPLETED NA

Vagus Nerve Stimulation as Treatment for Long Covid

NCT05608629

Long COVID Chronic Fatigue Syndrome

COMPLETED NA

Vagus Nerve Stimulator for Autism and Other Developmental Disorders

NCT06259201

Autism Spectrum Disorder Intellectual Disability Autonomic Nervous System +1 more

RECRUITING NA

Vagal Nerve Stimulation to Probe Inflammation and Brain in Post-traumatic Stress

NCT03858985

Post-traumatic Stress

COMPLETED PHASE1/PHASE2

Noninvasive Vagus Nerve Stimulation (VNS) for Neuromotor Adaptations

NCT03628976

Healthy Young Adults

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active tVNS - 2 Hz

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

Group Type EXPERIMENTAL

Active transcutaneous vagus nerve stimulation

Intervention Type OTHER

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

Active tVNS - 8 Hz

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

Group Type EXPERIMENTAL

Active transcutaneous vagus nerve stimulation

Intervention Type OTHER

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

Active tVNS - 30 Hz

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

Group Type EXPERIMENTAL

Active transcutaneous vagus nerve stimulation

Intervention Type OTHER

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

Active tVNS - 100 Hz

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

Group Type EXPERIMENTAL

Active transcutaneous vagus nerve stimulation

Intervention Type OTHER

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

Sham tVNS

Sham transcutaneous vagus nerve stimulation on the left auricle

Group Type SHAM_COMPARATOR

Sham transcutaneous vagus nerve stimulation

Intervention Type OTHER

stimulation of the auricle for 30 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Active transcutaneous vagus nerve stimulation

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

Intervention Type OTHER

Sham transcutaneous vagus nerve stimulation

stimulation of the auricle for 30 minutes

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) transcutaneous vagus nerve stimulation transcutaneous vagus nerve stimulation

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

24 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No