Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Stress Disorders, Post-Traumatic Clinical Trial

— VNS in PTSD  

Official title:

Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05517304
• Other study ID #: MHBP-004-21F
• Secondary ID: I01CX002331
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 15, 2026

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: Doug J Bremner, MD
• Phone: (404) 712-9569
• Email: James.Bremner[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 15, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Device:
• tcVNS
active stimulation with transcutaneous Vagal Nerve Stimulation (tcVNS)
• sham
sham stimulation

Locations

Country	Name	City	State
United States	Atlanta VA Medical and Rehab Center, Decatur, GA	Decatur	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to three months
Primary	brain	change in brain activation in insula measured with PET in response to trauma scripts with VNS compared to sham	baseline
Secondary	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	baseline
Secondary	interleukin-6	change in interleukin 6 concentration in blood in response to traumatic scripts with stimulation with VNS versus stimulation with sham	baseline