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Sympathetic Overactivity in Post-traumatic Stress Disorder
Post-traumatic stress disorder (PTSD) is a highly prevalent anxiety disorder that is associated with an increased risk of cardiovascular (CV) disease and hypertension. One potential mechanism is overactivation of the sympathetic nervous system (SNS), both at rest and particularly during stress. This study will evaluate whether 8 weeks of daily DGB therapy or transcutaneous vagus nerve stimulation (tVNS) therapy improves SNS activity at rest and during stress.
Conditions:
🦠 Post-traumatic Stress Disorder 🦠 Prehypertension
🗓️ Study Start (Actual) July 2012
🗓️ Primary Completion (Estimated) December 2024
✅ Study Completion (Estimated) December 2024
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Decatur, Georgia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Prehypertensive and normotensive veterans with PTSD, and prehypertensive and normotensive veterans without PTSD (controls)

    Exclusion Criteria:

    • * heart or vascular disease
    • * illicit drug use
    • * excessive alcohol use (\>2 drinks per day)
    • * pregnancy
    • * autonomic dysfunction
    • * medications known to affect SNS (clonidine)
    • * treatment with monoamine oxidase (MAO) inhibitors within the last 14 days
    • * any serious systemic disease
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 21 June 2012
  • First Submitted that Met QC Criteria 22 June 2012
  • First Posted 25 June 2012

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 September 2023
  • Last Update Posted 11 September 2023
  • Last Verified September 2023
I'm interested ...!!