| NCT ID | NCT06266364 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas at Dallas |
| Condition | PTSD, Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-12-30 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility 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
Contact & Investigator
Jane Wigginton, MD
PRINCIPAL INVESTIGATOR
The University of Texas at Dallas
Frequently Asked Questions
Who can join the NCT06266364 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, up to 79 Years, studying PTSD, Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06266364 currently recruiting?
Yes, NCT06266364 is actively recruiting participants. Contact the research team at alp160730@utdallas.edu for enrollment information.
Where is the NCT06266364 trial being conducted?
This trial is being conducted at Austin, United States, Dallas, United States, Richardson, United States.
Who is sponsoring the NCT06266364 clinical trial?
NCT06266364 is sponsored by The University of Texas at Dallas. The principal investigator is Jane Wigginton, MD at The University of Texas at Dallas. The trial plans to enroll 20 participants.
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