Vagal Nerve Stimulation in mTBI

Part of paid clinical trials in Decatur, Georgia.

Sponsor
VA Office of Research and Development
Study ID
NCT04437498
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • sham stimulation — DEVICE
    non invasive vagal nerve stimulation
  • nVNS — DEVICE
    active vns stimulation

Study Details

Mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD) are important conditions for the Veterans Administration (VA) that frequently occur together in combat Veterans from the conflicts in Afghanistan and Iraq. In many Veterans these become chronic, raising the risk the burden of neurotrauma can worsen over time. This study will examine a new intervention called non-invasive Vagal Nerve Stimulation (nVNS) and its effects on memory and symptoms of PTSD and mTBI as well as brain and physiology in Veterans with mTBI and PTSD.

Key Dates

Start date
Feb 25, 2021
Status verified
Oct 2025
Primary completion
May 21, 2026
Completion
Jul 9, 2026

Study Design

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

Arms

  • Experimental: nVNS
    non invasive vagal nerve stimulation
  • Sham Comparator: sham
    sham stimulation

Primary Outcome Measure

CAPS [ Time Frame: three months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Atlanta VA Medical and Rehab Center, Decatur, GADecaturGeorgia30033-4004
Ashley N Scales, PhD
[email protected]
(404) 321-6111
Doug J Bremner, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Decatur, GA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Atlanta VA Medical and Rehab Center, Decatur, GA· Decatur, GA

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