Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT05517304
Status
Recruiting
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Conditions

  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • tcVNS — DEVICE
    Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)
  • Sham — DEVICE
    Sham stimulation

Study Details

This study effects the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) or a sham control on brain, physiology, and PTSD symptoms in Veterans with posttraumatic stress disorder (PTSD). Veterans undergo brain imaging and physiological measures in conjunction with traumatic scripts before and after three months of twice daily treatment with tcVNS or sham stimulation at home.

Key Dates

Start date
Oct 1, 2022
Status verified
Feb 2026
Primary completion
Jul 8, 2027
Completion
Nov 10, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tcVNS
    Stimulation twice daily with transcutaneous Vagal Nerve Stimulation (tcVNS)
  • Active Comparator: Sham
    Stimulation with sham

Primary Outcome Measure

Change in PTSD symptoms [ Time Frame: Baseline to three months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Doug J Bremner, MD
[email protected]
(404) 712-9569
Doug J Bremner, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GA

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