Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

VA Office of Research and Development80 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Stress Disorders, Post-Traumatic

Interventions

tcVNSDEVICE

Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)

ShamDEVICE

Sham stimulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, United States

RECRUITING

Outcomes

Primary Outcomes

Change in PTSD symptoms

Change in PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) in tcVNS versus sham conditions

Time frame: Baseline to three months

Brain Activation

Change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham

Time frame: Baseline

Secondary Outcomes

Sympathetic function

Change in pre-ejection period (PEP) during traumatic scripts with VNS compared to sham. PEP is the time from ventricular contraction to aortic valve opening and is a measure of cardiac sympathetic tone

Time frame: Baseline

Interleukin-6

Change in interleukin 6 concentration in blood in response to traumatic scripts with stimulation with VNS versus stimulation with sham

Time frame: Baseline

Central Contacts

Doug J Bremner, MD

CONTACT

(404) 712-9569 James.Bremner@va.gov

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.