Evaluating the Safety and Effectiveness of the gammaCore Handheld Vagus Nerve Stimulation Device for Treating Post-Traumatic Stress Disorder PTSD Symptoms in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the gammaCore non-invasive vagus nerve stimulation nVNS device as an additional treatment for adults with post-traumatic stress disorder PTSD. The device may help regulate stress and emotional responses by stimulating the vagus nerve, which connects the brain to many body organs. This open-label pilot study aims to find out if regular use of the device at home can reduce PTSD symptoms and if it is safe for this purpose. Participants will first complete a 4-week baseline period without treatment to monitor their PTSD symptoms. Then, they will begin a 12-week treatment period using the gammaCore device at home, applying it to the side of the neck twice daily for about 2 minutes each time. Throughout the study, participants will attend six visits, some in person and some remotely, for training, assessments, and safety monitoring. During the study, participants will complete questionnaires and clinician assessments to measure PTSD symptoms and quality of life. Researchers will track any side effects or medical problems related to the device. The study will help understand whether non-invasive vagus nerve stimulation could be a useful treatment option for people living with PTSD.

Non-invasive Vagus Nerve Stimulation (nVNS) for Post-Traumatic Stress Disorder (PTSD)