Targeted Plasticity Therapy for PTSD
Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
This study is testing whether a new therapy that combines brain stimulation with talk therapy can help people with PTSD feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 22 Years to 79 Years |
| Sex | All |
| Sponsor | The University of Texas at Dallas Academic / other |
| Locations | 3 sites (Austin, Texas and 2 other locations) |
| Trial ID | NCT06266364 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 22-79 with a diagnosis of chronic PTSD who have not responded adequately to first-line treatments.
Not a fit: Patients currently undergoing prolonged exposure therapy elsewhere or those with a high risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve treatment outcomes for patients suffering from chronic PTSD.
How similar studies have performed: While the combination of VNS and PE is a novel approach, similar studies have shown promise in using VNS for various psychiatric conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Austin, Texas and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.