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Vagal Nerve Stimulation in mTBI

ConditionsPTSDmTBI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Veterans with mTBI and PTSD

Disqualifiers

amnesia for the inciting event lasted longer than 24 hours

Glasgow Coma Scale Score after 30 minutes was less than 13

loss of consciousness more than 30 minutes

positive pregnancy test

Trial design

Design model

Parallel

Treatments tested in this trial

  • sham stimulation

    Device

    non invasive vagal nerve stimulation

  • nVNS

    Device

    active vns stimulation

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: nVNSExperimental treatment 1 intervention
Group B: shamSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

CAPS

The Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS) is a measure of PTSD symptoms with a range of 0-80 and higher score indicating more severe PTSD symptoms. The investigators will compare change from baseline to post treatment with active vagal nerve stimulation (VNS) or sham stimulation twice daily.

Time frame
three months
2

insula

Blood flow in the insula is measured with positron emission tomography (PET) and radiolabelled water during the performance of stress tasks. The investigators will compare blood flow in the insula to whole brain blood flow ratio during stress tasks (listening to personalized traumatic scripts) versus control tasks in the VNS versus sham groups with hypothesis of blocked insula blood flow with VNS

Time frame
10 minutes
3

HVLT-R % retention

The Hopkins Verbal Learning Test-Revised (HVLT-R) is a test of declarative memory learning that involves the learning of 12 nouns, four from each of three semantic categories, learned over three learning trials, followed 20 minutes later by a delayed free recall trial and recognition trial composed of 24 words with 12 false positives. The percent (%) retention is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3. HLVT-R % retention has a range of 0-100 with 100 being best and 0 worst performance. Baseline and three months post treatment paired with sham or active stimulation are compared.

Time frame
baseline versus three months
4

Change in IL6 Concentration in Blood with Stress

Interleukin-6 (IL6) response to stress paired with active or sham stimulation. IL6 is an inflammatory biomarker measured in blood. The investigators will compare IL6 response to stress in VNS versus sham treated groups.

Time frame
Baseline to 120 minutes after stress

Secondary outcomes

1

PPG amplitude

Photoplethysmography (PPG) amplitude is a measure of peripheral vasoconstriction which is a marker of sympathetic response to stress with active or sham. PPG amplitude is the diameter of the blood vessel in the finger, the investigators will measure change from baseline to post active vagal nerve stimulation versus sham stimulation with stress.

Time frame
Change from baseline to 5 seconds after the termination of stimulation paired with stress

Other outcomes

Sponsors and contacts

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

VA Office of Research and Development

Lead sponsor

Atlanta VA Medical Center

Collaborator

Source ClinicalTrials.gov
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