Overview
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 participants will receive up to an additional 12 sessions of PE therapy paired with active VNS stimulation, regardless of their prior assignment in Phase 1.
Post-therapy assessments will be performed 1 day, 1 month, and 6 months following the completion of the final session of PE in Phase 2.
During the in-office sessions, the therapist will use a secure smart device to deliver stimulation and record audio of the session for use during homework sessions. The smart device will automatically trigger VNS during audio homework sessions at the same times that the therapist delivered VNS during the corresponding in-office session.
Long-term assessment of safety will be performed up to four times annually for up to 2 years following the date of implant or until the device is FDA approved when possible. Safety assessment will only report on the presence of the implanted, non-active device and/or participant status during this period. Participants who experience a serious device-related adverse event will be removed from the identified risk but will continue to be monitored for 2 years or longer if the event has not resolved.
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Currently undergoing prolonged exposure therapy elsewhere
- Concurrent participation in another interventional clinical trial
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
- Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
- Persons with a current or past: (a) medical (psychiatric, non-psychiatric)
condition, disease, disorder, injury, or disability or (b) non-medical situation or
circumstance that, in the opinion of the principal investigator, study
- participation
-
- may pose a significant or undue risk to the person,
- make it unlikely the person will complete all the study requirements per protocol, or
- may adversely impact the integrity of the data or the validity of the study results
- Persons with a neck circumference larger than 18.5 inches
- Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods
- Non-English speaking
- As determined by the principal investigator, is under current incarceration or legal detention