Vagal nerve stimulation for veterans with mild traumatic brain injury and PTSD
Non-Invasive Vagal Nerve Stimulation in Veterans With Mild Traumatic Brain Injury (mTBI)
This study is testing if a new treatment called Vagal Nerve Stimulation can help combat veterans with mild brain injuries and PTSD improve their memory and manage stress better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT04437498 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive Vagal Nerve Stimulation (nVNS) on memory and symptoms in combat veterans suffering from mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD). It will assess cognitive performance and physiological responses during stressful tasks, measuring memory performance, inflammatory markers, and brain activity using advanced imaging techniques. The goal is to determine whether nVNS can enhance memory and reduce stress responses compared to a sham treatment over a four-day period.
Who should consider this trial
Good fit: Ideal candidates are veterans diagnosed with both mild traumatic brain injury and posttraumatic stress disorder.
Not a fit: Patients with a history of serious neurological disorders or those currently undergoing specific psychiatric treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve memory and reduce PTSD symptoms in veterans with mTBI.
How similar studies have performed: While the approach of using nVNS is relatively novel, similar studies have shown promising results in other populations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veterans with mTBI and PTSD Exclusion Criteria: * amnesia for the inciting event lasted longer than 24 hours * Glasgow Coma Scale Score after 30 minutes was less than 13 * loss of consciousness more than 30 minutes * positive pregnancy test * meningitis or other neurological disorder other than mTBI * alcohol or substance abuse use disorder based on the SCID within the past 12 months * current or lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, anorexia nervosa or bulimia, based on the SCID * active suicidal ideation based on criteria outlined below * a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness * active neuroleptic, opiate, or benzodiazepine treatment * structural abnormality on brain MRI or CT
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.