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Clinical Trial NCT04437498 (VNS mTBI) for PTSD, mTBI is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Vagal Nerve Stimulation in mTBI (VNS mTBI) 100 Non-Invasive Veterans

Recruiting
Clinical Trial NCT04437498 (VNS mTBI) is an interventional study for PTSD, mTBI that is recruiting. It started on February 25, 2021 with plans to enroll 100 participants. Led by VA Office of Research and Development, it is expected to complete by July 9, 2026. The latest data from ClinicalTrials.gov was last updated on October 24, 2025.
Brief Summary
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 Stimulati...Show More
Detailed Description
This projects will assess the effects of non-invasive Vagal Nerve Stimulation (nVNS) on neurobiology and cognition in combat Veterans with mild Traumatic Brain Injury (mTBI) and co-morbid posttraumatic stress disorder (PTSD) during the performance of stressful tasks (traumatic scripts, mental arithmetic) and verbal declarative memory tasks using measurement of memory performance, peripheral inflammatory markers in bl...Show More
Official Title

Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)

Conditions
PTSDmTBI
Other Study IDs
NCT ID Number
NCT04437498
Start Date (Actual)
2021-02-25
Last Update Posted
2025-10-24
Completion Date (Estimated)
2026-07-09
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
vagus nerve
stress disorders, posttraumatic
traumatic brain injury
memory
hippocampus
emission tomography
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalnVNS
non invasive vagal nerve stimulation
nVNS
active vns stimulation
Sham Comparatorsham
sham stimulation
sham stimulation
non invasive vagal nerve stimulation
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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. We will compare change from baseline to post treatment with active vagal nerve stimulation (VNS) or sham stimulation twice daily.
three months
insula
Blood flow in the insula is measured with positron emission tomography (PET) and radiolabelled water during the performance of stress tasks. We 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
10 minutes
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.
baseline versus three months
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. We compare IL6 response to stress in VNS versus sham treated groups.
Baseline to 120 minutes after stress
hippocampal activation
Blood flow in the hippocampus is measured with positron emission tomography (PET) and radiolabelled water during the performance of declarative memory tasks. We 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
10 minutes
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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, we measure change from baseline to post active vagal nerve stimulation versus sham stimulation with stress.
Change from baseline to 5 seconds after the termination of stimulation paired with stress
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Veterans with mTBI and PTSD

  • 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
VA Office of Research and Development logoVA Office of Research and Development
Atlanta VA Medical Center logoAtlanta VA Medical Center
Study Central Contact
Contact: Doug J Bremner, MD, (404) 712-9569, [email protected]
Contact: Anna Woodbury, MD, (404) 321-6111, [email protected]
1 Study Locations in 1 Countries

Georgia

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur, Georgia, 30033-4004, United States
Ashley N Scales, PhD, Contact, (404) 321-6111, [email protected]
Doug J Bremner, MD, Principal Investigator
Recruiting