Vagal nerve stimulation for veterans with PTSD
Transcutaneous Vagal Nerve Stimulation in Veterans With Posttraumatic Stress Disorder
NA · VA Office of Research and Development · NCT05517304
This study is testing if a new treatment using vagal nerve stimulation can help veterans with PTSD feel better by looking at changes in their brain function and symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development (fed) |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT05517304 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous cervical vagal nerve stimulation (tcVNS) on brain function and PTSD symptoms in veterans diagnosed with posttraumatic stress disorder. Participants will undergo brain imaging and physiological assessments while exposed to traumatic scripts, followed by three months of at-home treatment with either tcVNS or a sham device. The study aims to measure changes in brain activity, inflammatory biomarkers, and sympathetic function before and after the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 18 to 75 with a diagnosis of PTSD based on DSM-5 criteria.
Not a fit: Patients with a history of significant traumatic brain injury, severe psychiatric disorders, or other serious medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel non-invasive treatment option for veterans suffering from PTSD.
How similar studies have performed: Previous studies using similar approaches have shown promise, with the tcVNS device receiving Breakthrough Device Designation from the FDA for PTSD treatment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (RECRUITING)
Study contacts
- Principal investigator: Doug J Bremner, MD — Atlanta VA Medical and Rehab Center, Decatur, GA
- Study coordinator: Doug J Bremner, MD
- Email: James.Bremner@va.gov
- Phone: (404) 712-9569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stress Disorders, Post-Traumatic, PTSD, Vagus Nerve