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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Active VNS stimulation
DeviceThe subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
Sham VNS stimulation
DeviceThe subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Immediate VNS GroupActive comparator 1 intervention
Group B: Delayed VNS GroupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
ReStore System Safety
ReStore System safety by review of any adverse events
Time frame
From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes firstSecondary outcomes
1
Clinician Administered PTSD Scale for DSM-5(fifth edition of the Diagnostic and Statistical Manual of Mental Disorders)(CAPS-5)
The CAPS-5 is a 30-item structured PTSD diagnostic interview that measures PTSD. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms symptoms.
Time frame
From baseline up to visit 33 (end of study)2
PTSD Checklist for DSM-5 (PCL-5) score
The PCL-5 is a 20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. Total scores range from 0-80, with higher scores indicating more severe PTSD symptoms symptoms.
Time frame
From baseline up to visit 33 (end of study)3
PostTraumatic Cognitions Inventory (PTCI)
The PTCI is a 33-item instrument that assesses dysfunctional post-trauma cognitions across self, world, and self-blame to yield a total score. Total scores range from 33-231, with higher scores reflecting greater endorsement of negative posttraumatic cognitions.
Time frame
From baseline up to visit 33 (end of study)4
Generalized Anxiety Disorder 7-item Scale (GAD-7)
The GAD-7 is a 7-item questionnaire that measures severity of anxiety. Total scores range from 0-21, with higher scores reflecting severe anxiety symptom levels.
Time frame
From baseline up to visit 33 (end of study)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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