Targeted Plasticity Therapy for PTSD
Recruiting now · Not applicable · Has a placebo group
Conditions studied: PTSD, Post Traumatic Stress Disorder
In brief
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)
Key facts
- Study ID
- NCT06266364
- Run by
- The University of Texas at Dallas
- People needed
- 20
- Starts
- 2024-12-30
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-06-08
Who can join
Age: 22 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The University of Texas Health Austin Ambulatory Surgery Center — Austin, Texas, United States (enrolling)
- Baylor University Medical Center — Dallas, Texas, United States (enrolling)
- Texas Biomedical Device Center — Richardson, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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