Targeted Plasticity Therapy for Posttraumatic Stress Disorder
- Conditions
- Post Traumatic Stress Disorder
- Interventions
- Device: Paired Vagus Nerve Stimulation
- Registration Number
- NCT04064762
- Lead Sponsor
- Baylor Research Institute
- Brief Summary
Posttraumatic stress disorder is a debilitating condition that develops in the aftermath of a traumatic experience, leading to hyperarousal, heightened anxiety, and uncontrolled fear that can be driven by intrusive memories or trauma reminders. The Texas Biomedical Device Center has developed a novel technique, termed targeted plasticity therapy (TPT), to boost neuroplasticity in conjunction with various forms of rehabilitation, including prolonged exposure therapy. The technique involves stimulation of the vagus nerve. The purpose of this open-label pilot study is to assess the safety of using a new device to deliver vagus nerve stimulation to reduce symptom severity in participants with PTSD when paired with prolonged exposure therapy. Additionally, the study will assess the prospective benefit of the system and garner an initial estimate of efficacy for a subsequent trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vagus Nerve Stimulation + Prolonged Exposure Therapy Paired Vagus Nerve Stimulation Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events [Device Safety] From Week 1 through study follow-up, approximately two years from the date of implant Review of adverse events reported throughout the trial will be used to inform the potential risks associated with the ReStore system and provide a better understanding of risk/benefit analysis.
- Secondary Outcome Measures
Name Time Method PTSD Checklist for DSM-5 (PCL-5) Weeks 1, 9-15, 19, 36, 62 The PCL-5 is a 20 item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. (Weathers, Litz, Keane, et al. 2013).
Generalized Anxiety Disorder 7-item Scale (GAD-7) Weeks 9, 15, 19, 36, 62 The GAD7 is a 7-item questionnaire that measures severity of anxiety (Spitzer et al, 2006). Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Weeks 1, 9, 15, 19, 36, 62 The CAPS-5 is a 30-item structured PTSD diagnostic interview that measures PTSD symptoms. (Weathers, Bovin, Lee, et al. 2018).
Patient Health Questionnaire-9 (PHQ-9) Weeks 1, 9-15, 19, 36, 62 The PHQ-9 is a brief self-report measure of major depressive disorder (Kroenke et al, 2001). The PHQ-9 is considered to be a valid measure of depression for population-based studies and clinical populations (Corson, Gerrity, \& Dobscha, 2004) with a cut off score of equal or greater than 10 as the diagnostic for current depression.
Posttraumatic Cognitions Inventory (PTCI) Weeks 9-15, 19, 36, 62 The PTCI is a 36-item instrument that assesses dysfunctional post-trauma cognitions across self, world, and self-blame to yield a total score (Foa et al., 1999). The scale has high internal consistencies (.97, .88, .86, .97, respectively) and correlates well with PTSD severity, anxiety, and depression (.44 to .79).
Trial Locations
- Locations (1)
Baylor University Medical Center
🇺🇸Dallas, Texas, United States