Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)
• Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
• In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) guidelines
• PCL-5 score greater than 33
• Age 22-79 years
• Appropriate surgical candidate for VNS device implantation
• Willing and able to comply with study protocol
• Able to provide informed consent.