Targeted Plasticity Therapy for Posttraumatic Stress Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- Baylor Research Institute
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events [Device Safety]
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of Adverse Events [Device Safety]
Time Frame: 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 Outcomes
- PTSD Checklist for DSM-5 (PCL-5)(Weeks 1, 9-15, 19, 36, 62)
- Generalized Anxiety Disorder 7-item Scale (GAD-7)(Weeks 9, 15, 19, 36, 62)
- Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)(Weeks 1, 9, 15, 19, 36, 62)
- Patient Health Questionnaire-9 (PHQ-9)(Weeks 1, 9-15, 19, 36, 62)
- Posttraumatic Cognitions Inventory (PTCI)(Weeks 9-15, 19, 36, 62)