Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: tcVNS, Sham.
- Who it may be relevant to
- Registry conditions: Stress Disorders, Post-Traumatic. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Device tcVNS
Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS) - Device Sham
Sham stimulation
Primary outcome measures
- Change in PTSD symptoms [Time frame: Baseline to three months]
- Brain Activation [Time frame: Baseline]
Secondary outcome measures (2)
- Sympathetic function [Time frame: Baseline]
- Interleukin-6 [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
Identifiers
NCT: NCT05517304 · MHBP-004-21F · I01CX002331