Targeted Plasticity Therapy for PTSD
ConditionPTSD, Post Traumatic Stress Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-79
SponsorThe University of Texas at Dallas
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Active VNS stimulation
- Sham VNS stimulation
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
The University of Texas at Dallas
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
Source ClinicalTrials.gov