PTSD Treatment Research Study
Researchers at the University of Texas at Austin are testing a device combined with exposure therapy to treat PTSD. The study aims to see if this approach is safe and helps improve symptoms more effectively.
Fast Facts
Diagnosed With PTSD And Have Not Responded To Treatment
Currently Experiencing Avoidance Symptoms
Compensation Provided
Conducted in
UT Austin
Study Background
Can Vagus Nerve Stimulation Help Treat PTSD?
The purpose of this study is to test the safety of using the ReStore System to deliver vagus nerve stimulation during Prolonged Exposure therapy (PE, an evidence-based psychological treatment for PTSD) and see what effects (good and bad) it has on you and others with PTSD. The ReStore System consists of a very small vagus nerve stimulator that is implanted on the vagus nerve in the neck.
Prolonged exposure therapy by itself has been shown to be effective for persons diagnosed with PTSD. Adding vagus nerve stimulation (VNS) triggers the vagus nerve, which is a part of the nervous system responsible for providing signals between the brain and body. Studies in animals show that VNS enhances extinction learning, a form of learning in which fears are progressively weakened. Reduction in fear is thought to be important for the treatment of PTSD.
During therapy, you will wear a neckband to trigger VNS. You will be in the study for about one year. Long-term assessment of safety will be performed twice yearly for up to 2 years after your implant date when possible.
Your participation in this study may help researchers improve treatment approaches for PTSD. Further research today and join our compensated study!
Study Background
Can Vagus Nerve Stimulation Help Treat PTSD?
The study will use the ReStore System, which is designed to reduce risks compared to older devices. The main goal is to test how safe it is to combine VNS with PE therapy and see how it affects people with PTSD.
Researchers at the University of Texas at Austin are testing whether Vagus Nerve Stimulation (VNS) can improve the effectiveness of Prolonged Exposure (PE) therapy for PTSD. Studies in animals have shown that VNS makes exposure therapy both easier to tolerate and more effective. That may improve one aspect but not the other. VNS is already proven safe for treating conditions like epilepsy, and early studies suggest it could also help reduce PTSD symptoms.
Additional Information
This study is being done to test whether combining Vagus Nerve Stimulation (VNS) with Prolonged Exposure therapy can be done safely and to see what effects, good and bad, it may have on people with PTSD.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Adults 22-79 years old
- Diagnosed with PTSD 3+ months ago
- Attempted at least one treatment for PTSD that proved unsuccessful
- If applicable, willing to use a medically acceptable birth control method (implant, IUD, oral contraceptives, patch, ring, sterilization) for the duration of the study
- Read and speak English
Exclusion Criteria
- Currently receiving prolonged exposure therapy for PTSD elsewhere
- Currently taking part in another research study that involves medical treatments or interventions
- Experienced an injury to the vagus nerve
- Received prior or current treatment with vagus nerve stimulation
- Pregnant or planning to become pregnant in the next 6 months
- Have a cardiac pacemaker
If you participate in this study, here’s what you can expect:
Pre-Therapy Phase (6 weeks): You’ll start by completing screening and learning more about the study. You will meet with trial coordinators and provide consent to participate if you agree. If you decide to participate, you’ll have surgery to implant the VNS device. After surgery, you’ll have some time to recover, and you’ll meet with trial coordinators again to go over the next steps together.
Phase 1 (11 weeks): You’ll have 12 therapy sessions where you’ll either receive active VNS treatment or a placebo (sham) VNS. This will be assigned randomly, like flipping a coin.
Phase 2 (11 weeks): You’ll receive active VNS along with up to 12 more therapy sessions. After this phase, there will be some follow-up assessments to check on your progress.
Ongoing Check-ins: You’ll have periodic assessments throughout the study, with safety evaluations twice a year for up to 2 years after the VNS device is implanted.
Participants can receive compensation up to $1,850 for their time and effort upon completing all study activities.
There is no cost for you to participate in our research study.