Targeted Plasticity Therapy for PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of the ReStore system, which utilizes Vagus Nerve Stimulation (VNS) therapy combined with Prolonged Exposure Therapy (PE) for individuals with post-traumatic stress disorder (PTSD). Participants will be randomly assigned to receive either active VNS stimulation or sham stimulation during their therapy sessions. The study consists of a double-blinded Phase 1 followed by an open-label Phase 2, where all participants will receive active VNS stimulation. Assessments will be conducted at various intervals post-therapy to evaluate outcomes and safety over time.

Why it matters

Who can join: the full rules

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 interventional clinical trial
3. Prior injury to vagus nerve
4. Prior or current treatment with vagus nerve stimulation
5. Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
7. 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
8. Persons with a neck circumference larger than 18.5 inches
9. 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
10. Non-English speaking
11. As determined by the principal investigator, is under current incarceration or legal detention

Where it's running

• The University of Texas Health Austin Ambulatory Surgery Center
  Austin, Texas, United States Recruiting
• Baylor University Medical Center
  Dallas, Texas, United States Recruiting
• Texas Biomedical Device Center
  Richardson, Texas, United States Recruiting

Study contacts

• Principal investigator: Jane Wigginton, MD — The University of Texas at Dallas
• Study coordinator: Amy Porter
• Email: alp160730@utdallas.edu
• Phone: 972-883-7256

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.