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

NCT03858985 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-04-10

No results posted yet for this study

Summary

The proposal aims to determine if non-invasive vagus nerve stimulation(nVNS) will alter: 1) the peripheral inflammatory biomarker profile, 2) the neural correlates of change in pain stimuli and 3) PTSD symptom severity and 4) life quality and function in Veterans with PTSD. The planned inflammatory biomarker and neuroimaging results can 1) promote knowledge of inflammatory and neurobiological mechanisms that contribute to pain in PTSD, and 2) advance the ability to provide targeted neuromodulation based interventions that support improved life quality and function for Veterans. These goals are consistent with the VA's mission to sponsor research examining variables related to pathogenesis, diagnosis, and(ultimately) treatment of neuropsychiatric disorders.

Conditions

  • Post-traumatic Stress

Interventions

DEVICE

Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)

Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).

DEVICE

Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)

Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Imanuel R Lerman, MD MSc · VA San Diego Healthcare System, San Diego, CA

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2025-03-31
Completion
2025-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858985 on ClinicalTrials.gov