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Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
NCT05517304 · VA Office of Research and Development
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
Description: This study assesses brain function measured with High Resolution Positron Emission Tomography (HR-PET) during exposure to stressful traumatic scripts paired with tcVNS or sham stimulation, with secondary measures of blood inflammatory biomarkers, and sympathetic function. Participants then undergo three months of twice daily home treatment with repeat measures.
Drug/Device Handling: \[O-15\] radiolabeled water has a half-life of 110 seconds and is made on site at the Emory Center for Systems Imaging (CSI). Dr. Bremner holds the Investigational New Drug (IND) approval for use of radiolabeled water at Emory University. The investigators have performed hundreds of studies in human subjects at Emory and there have been no adverse events or untoward effects to date.
tcVNS with the GammaCore device is approved by the Emory IRB for a recently completed study in PTSD and others in progress for Opioid Use Disorder and was shown to be well tolerated and there have been no adverse events or untoward effects with the device. The FDA granted Breakthrough Device Designation for PTSD for the gammaCore tcVNS device based on the investigators' studies. Devices are blinded by ElectroCore and the devices and information are kept by the Data Manager under double lock and key. Device records are kept by the Data Manager and stored on Redcap or secured research drives. Devices are given to the study team along with a device schedule under direct supervision from the investigator.
Eligibility criteria
Inclusion Criteria:
* Veterans between the ages of 18 and 75 will be included with a diagnosis of PTSD based on DSM-5 criteria
Exclusion Criteria:
Subjects will be excluded with:
* a history of mild traumatic brain injury (mTBI) based on VA Criteria
* moderate or greater TBI
* positive pregnancy test
* meningitis or other neurological disorder
* alcohol or substance abuse use disorder based on DSM-5 criteria within the past 12 months
* current or lifetime history of schizophrenia, schizoaffective disorder, bipolar I disorder, anorexia nervosa or bulimia, based on DSM-5
* active suicidal ideation with a plan
* a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness that would preclude participation based on clinical judgment of the PI
* active opiate or benzodiazepine treatment
* history of structural abnormality on brain MRI or CT if one has been performed in the past
Study design
Enrollment target: 80 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2022-10-01
Estimated completion: 2027-11-10
Last updated: 2026-03-03
Interventions
Device: tcVNSDevice: Sham
Primary outcomes
- • Change in PTSD symptoms (Baseline to three months)
- • Brain Activation (Baseline)
Sponsor
VA Office of Research and Development · fed
Contacts & investigators
ContactDoug J Bremner, MD · contact · James.Bremner@va.gov · (404) 712-9569
InvestigatorDoug J Bremner, MD · principal_investigator, Atlanta VA Medical and Rehab Center, Decatur, GA
All locations (1)
Atlanta VA Medical and Rehab Center, Decatur, GARecruiting
Decatur, Georgia, United States