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Targeted Plasticity Therapy for PTSD
Sponsor: The University of Texas at Dallas
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)
Official title: Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder
Key Details
Gender
All
Age Range
22 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-12-30
Completion Date
2028-06
Last Updated
2025-07-03
Healthy Volunteers
No
Conditions
Interventions
Active VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
Sham VNS stimulation
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
Locations (3)
The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Texas Biomedical Device Center
Richardson, Texas, United States