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)
A prospective, multi-center, randomized, controlled, blinded trial of participants implanted with the ReStore Device for VNS Therapy. In double-blinded Phase 1, after implantation, participants will be randomized to either active VNS stimulation or sham VNS stimulation, accompanying PE therapy twice weekly for 7 weeks (12 in-office sessions, Phase 1). The therapist and the participant will be blinded of the group assignment. Following completion of Phase 1, all participants undergo two mid-therapy assessments and then advance to the open-label Phase 2. In open-label Phase 2, all participants will receive up to an additional 12 sessions of PE therapy paired with active VNS stimulation, regardless of their prior assignment in Phase 1. Post-therapy assessments will be performed 1 day, 1 month, and 6 months following the completion of the final session of PE in Phase 2. During the in-office sessions, the therapist will use a secure smart device to deliver stimulation and record audio of the session for use during homework sessions. The smart device will automatically trigger VNS during audio homework sessions at the same times that the therapist delivered VNS during the corresponding in-office session. Long-term assessment of safety will be performed up to four times annually for up to 2 years following the date of implant or until the device is FDA approved when possible. Safety assessment will only report on the presence of the implanted, non-active device and/or participant status during this period. Participants who experience a serious device-related adverse event will be removed from the identified risk but will continue to be monitored for 2 years or longer if the event has not resolved.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1
The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1
The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, United States
RECRUITINGBaylor University Medical Center
Dallas, Texas, United States
RECRUITINGTexas Biomedical Device Center
Richardson, Texas, United States
RECRUITINGReStore 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 first
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)
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)
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)
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)
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a brief self-report measure of major depressive disorder. Total scores range from 0-27, with higher scores reflecting severe depression symptom levels.
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Time frame: From baseline up to visit 33 (end of study)