Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder (VNS in PTSD)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doug J Bremner, MD
- Phone Number: (404) 712-9569
- Email: James.Bremner@va.gov
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033-4004
- Recruiting
- Atlanta VA Medical and Rehab Center, Decatur, GA
-
Contact:
- Doug J Bremner, MD
- Phone Number: (404) 712-9569
- Email: James.Bremner@va.gov
-
Principal Investigator:
- Doug J Bremner, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: tcVNS
Stimulation twice daily with transcutaneous Vagal Nerve Stimulation (tcVNS)
|
Active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)
|
|
Active Comparator: Sham
Stimulation with sham
|
Sham stimulation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in PTSD symptoms
Time Frame: Baseline to three months
|
Change in PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and PTSD Checklist (PCL) in tcVNS versus sham conditions
|
Baseline to three months
|
|
Brain Activation
Time Frame: Baseline
|
Change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sympathetic function
Time Frame: Baseline
|
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
|
Baseline
|
|
Interleukin-6
Time Frame: Baseline
|
Change in interleukin 6 concentration in blood in response to traumatic scripts with stimulation with VNS versus stimulation with sham
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Doug J Bremner, MD, Atlanta VA Medical and Rehab Center, Decatur, GA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MHBP-004-21F
- I01CX002331 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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