New Therapy for Posttraumatic Stress Disorder

A research study opportunity

Researchers from Baylor Scott & White Research Institute and the Texas Biomedical Device Center at The University of Texas at Dallas have teamed up to assess if implanted vagus nerve stimulation (VNS) can make Prolonged Exposure Therapy (a psychological treatment) more tolerable and effective for reducing symptom severity in participants with posttraumatic stress disorder (PTSD). Therapy will take place over six weeks and follow-ups will occur at 1, 3, and 6 months after therapy ends. Participants will be compensated for their time in the study. This device is investigational and not FDA approved.

Key Eligibility Requirements:

• Must be a person diagnosed with chronic PTSD for at least 3 months
• Must be between the ages of 18 and 64 years

For more details, contact Emma Turner at 214-865-2416 or email [email protected].

Learn more at BSWHealth.com/Research

Frequently Asked Questions

What is the purpose of the trial?

Researchers from Baylor Scott & White Research Institute and the Texas Biomedical Device Center at The University of Texas at Dallas have teamed up to assess if implanted vagus nerve stimulation (VNS) can make Prolonged Exposure Therapy (a psychological treatment) more tolerable and effective for reducing symptom severity in participants with posttraumatic stress disorder (PTSD).

What activities does the trial involve?

Before enrollment in the trial, participants will go through a few steps to determine if they are eligible to be in the trial. First will be a call with a trial staff member to go over basic information and a brief set of questions to determine if they seem like a good fit for the study. If they are, the participant will be scheduled for an initial visit to go over and sign the consent form. After consenting to the study, there will be a more in depth assessment to find out if the participant can continue in the study; this is called screening and will be in person with the trial’s Chief Medical Officer and other trial staff.

If eligible, participants will be enrolled in the study and scheduled for surgery to implant the device. This surgery is expected to take about 60 minutes and involves one small incision on the left side of the neck. Participants will be asleep during surgery.

After surgery, participants will recover for about one week before starting Prolonged Exposure Therapy. Participants will attend 12 in-office sessions with a PTSD therapist during which VNS will be delivered using a secure smart phone. Participants will also complete homework using the smart phone to listen to each recorded therapy session while receiving vagus nerve stimulation from the comfort of home. Following completion of therapy, participants will come back for follow-up visits at 1, 3, and 6 months and then will be checked on periodically for as long as the device remains implanted.

What is the device and system?

The system is called the ReStore System. It consists of a very small vagus nerve stimulator that sits on the vagus nerve in the neck and two devices used to trigger the vagus nerve stimulation: 1) the Power and Communication Device (PCM) and 2) the study phone. The PCM is worn externally in a neckband and powers, communicates with, and controls the VNS device. The study phone programs and controls the VNS device. This device is investigational and not FDA approved.

Where is the trial taking place?

The trial will take place at the Baylor University Medical Center in Dallas.

How often do the visits take place?

Participants will be asked to attend about 20 study visits total, including: a screening visit, a pre-operative visit, the outpatient surgery, a post-operative visit, a baseline assessment visit, and 12 visits over the course of 6 weeks (or two visits per week) for Prolonged Exposure Therapy paired with vagus nerve stimulation. These 12 therapy visits will take approximately 2 hours each. Participants will then return to the office for 3 follow-up visits at 1, 3, and 6 months following the end of therapy.

Participants will receive $70 for each visit and an additional $70 for completing all 20 visits. There is no cost to take part in the study. No additional funds will be provided for parking and transportation.

What kind of assessments are involved?

Throughout the study, the participant will be completing assessments with the therapist as well as assessments filled out on their own. All assessments are well validated psychological measures used to assess for PTSD, anxiety, depression, etc. All answers will be stored in a secure location with only the participant identification number at the top.

How does the therapy work?

Participants will receive 2, 60-minute sessions each week for 6 weeks (12 total sessions). Prolonged Exposure (PE) Therapy includes education about common reactions to trauma, breathing retraining, and prolonged (repeated) imaginal exposure to trauma memories. Participants will be asked to perform homework exercises in accordance with standard exposure therapy. For this trial, PE Therapy will include vagus nerve stimulation to reduce the fear response in people with PTSD.