Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
The University of Texas at Dallas
Summary
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)
Description
A prospective, multi-center, randomized, controlled, blinded trial of participants implanted with the ReStore Device for VNS Therapy. In double-blinded Phase 1, after implantation, participants will be randomized to either active VNS stimulation or sham VNS stimulation, accompanying PE therapy twice weekly for 7 weeks (12 in-office sessions, Phase 1). The therapist and the participant will be blinded of the group assignment. Following completion of Phase 1, all participants undergo two mid-therapy assessments and then advance to the open-label Phase 2. In open-label Phase 2, all participant…
Eligibility
- Age range
- 22–79 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria 2. 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 3. PCL-5 score greater than 33 4. Age 22-79 years 5. Appropriate surgical candidate for VNS device implantation 6. Willing and able to comply with study protocol 7. Able to provide informed consent. Exclusion Criteria: 1. Currently undergoing prolonged exposure therapy elsewhere 2. Concurrent participation in another…
Interventions
- DeviceActive VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
- DeviceSham VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
Locations (3)
- The University of Texas Health Austin Ambulatory Surgery CenterAustin, Texas
- Baylor University Medical CenterDallas, Texas
- Texas Biomedical Device CenterRichardson, Texas