Health TrialsbyHealthPanel

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

ConditionStress Disorders, Post-Traumatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria

Disqualifiers

a history of mild traumatic brain injury (mTBI) based on VA Criteria

moderate or greater TBI

positive pregnancy test

meningitis or other neurological disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • tcVNS

    Device

    Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)

  • Sham

    Device

    Sham stimulation

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: tcVNSExperimental treatment 1 intervention
Group B: ShamActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in PTSD symptoms

Change in PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) in tcVNS versus sham conditions

Time frame
Baseline to three months
2

Brain Activation

Change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham

Time frame
Baseline

Secondary outcomes

1

Sympathetic function

Change in pre-ejection period (PEP) during traumatic scripts with VNS compared to sham. PEP is the time from ventricular contraction to aortic valve opening and is a measure of cardiac sympathetic tone

Time frame
Baseline
2

Interleukin-6

Change in interleukin 6 concentration in blood in response to traumatic scripts with stimulation with VNS versus stimulation with sham

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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