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Vagal Nerve Stimulation for mTBI and PTSD in Veterans

This study is looking at a new treatment called non-invasive Vagal Nerve Stimulation (nVNS) for veterans who have both mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD). Researchers want to see if nVNS can improve memory and reduce symptoms of PTSD and mTBI. You might be able to join if you are a veteran between 18 and 55 years old with mTBI and PTSD. The study will compare nVNS to a "sham stimulation" (a device that looks like nVNS but doesn't deliver treatment). Success would mean that nVNS improves memory, brain activity, and reduces stress responses and PTSD symptoms compared to the sham treatment. The current status of this study is unclear.

Study design
This interventional study plans to enroll 100 participants. It compares active nVNS stimulation to sham stimulation.
What's involved
Participants will undergo assessments of memory performance, blood tests for inflammatory markers, and cardiovascular measurements. Brain responses will also be measured, and treatments will be given twice daily over a four-day period.
Compensation
Not stated in the trial record.
Follow-up
Participants will have repeat assessments after three months of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04437498

Vagal Nerve Stimulation in mTBI

Recruiting
NAAges 18–55InterventionalTreatment
VA Office of Research and Development
~100 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:sham stimulationnVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CAPS
Measured over three months
+4 more outcomes measured

Conditions

PTSD
mTBI

Explore related trials

Post-Traumatic Stress DisorderTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Doug J Bremner, MD · PRINCIPAL_INVESTIGATOR · Atlanta VA Medical and Rehab Center, Decatur, GA

Who to contact

Doug J Bremner, MD
[email protected]
(404) 712-9569
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Veterans with mTBI and PTSD

Exclusion

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
meningitis or other neurological disorder other than mTBI
alcohol or substance abuse use disorder based on the SCID within the past 12 months
current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID
active suicidal ideation based on criteria outlined below
a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
active neuroleptic, opiate, or benzodiazepine treatment
structural abnormality on brain MRI or CT

What this trial measures

  • CAPSthree months

    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.

  • insula10 minutes

    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

  • HVLT-R % retentionbaseline versus three months

    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.

  • Change in IL6 Concentration in Blood with StressBaseline to 120 minutes after 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.

  • hippocampal activation10 minutes

    Blood flow in the hippocampus is measured with positron emission tomography (PET) and radiolabelled water during the performance of declarative memory tasks. The investigators will compare blood flow in the hippocampus to whole brain blood flow ratio during memory tasks versus control tasks in the VNS versus sham groups with hypothesis of increased hippocampal blood flow with VNS