Actively Recruiting
Targeted Plasticity Therapy for PTSD
Led by The University of Texas at Dallas · Updated on 2025-07-03
20
Participants Needed
3
Research Sites
178 weeks
Total Duration
On this page
Sponsors
T
The University of Texas at Dallas
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Targeted Plasticity Therapy for PTSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
- Failed at least one adequate course of first-line PTSD treatment per American Psychological Association guidelines
- PCL-5 score greater than 33
- Age 22 to 79 years
- Appropriate surgical candidate for VNS device implantation
- Willing and able to comply with study protocol
- Able to provide informed consent
You will not qualify if you...
- Currently undergoing prolonged exposure therapy elsewhere
- Participating in another interventional clinical trial
- Prior injury to vagus nerve
- Prior or current treatment with vagus nerve stimulation
- Psychiatric disorders or cognitive impairments interfering with study participation
- Moderate to high risk of suicide per Columbia-Suicide Severity Rating Scale
- Medical or non-medical conditions that pose significant risk, affect study completion, or data validity as determined by the investigator
- Neck circumference larger than 18.5 inches
- Females of childbearing potential who are pregnant, planning pregnancy, or not using medically acceptable birth control
- Non-English speaking
- Currently incarcerated or under legal detention as determined by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, United States, 78712
Actively Recruiting
2
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
3
Texas Biomedical Device Center
Richardson, Texas, United States, 75080
Actively Recruiting
Research Team
A
Amy Porter
CONTACT
K
Katharine Dlouhy
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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