Targeted Plasticity Therapy for Posttraumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT04064762|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Device: Paired Vagus Nerve Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Plasticity Therapy for Posttraumatic Stress Disorder|
|Estimated Study Start Date :||July 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2025|
Experimental: Vagus Nerve Stimulation + Prolonged Exposure Therapy
Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.
Device: Paired Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
- Incidence of Adverse Events [Device Safety] [ Time Frame: From Week 5 [Implantation] 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.
- PTSD Symptom Scale for DSM-5 (PSSI-5) [ Time Frame: Weeks 1, 9, 15, 19, 36, 62 ]The PSSI-5 is a 24-item, psychometrically validated, semi-structured interview that assesses PTSD symptoms in the past two weeks, and makes a diagnostic determination based on the DSM-5 criteria (Foa et al., 2016b). The PSSI-5 screens for the presence of a Criterion A traumatic event, the "index trauma," which functions as the focus of the interview, meaning that all other items refer to that event. Questions assess for PTSD symptoms corresponding to the 4 DSM-5 clusters of re-experiencing, avoidance, changes in mood and cognition, and arousal and hyperactivity, in addition to interference, distress, and duration of symptoms. The interviewer rates participant responses to symptom questions on a 5-point scale of frequency and severity, from 0 ("Not at all") to 4 ("6 or more times a week/severe").
- Posttraumatic Diagnostic Scale for DSM-5 (PDS-5) [ Time Frame: Weeks 9-15, 19, 36, 62 ]The PDS-5 is a 20-item psychometrically validated measure designed to confirm a diagnosis of PTSD and measure the severity of PTSD symptoms (Foa et al., 2016a). Severity is measured on a scale from 0 to 51. The measure is based on the DSM-5 diagnostic criteria for PTSD.
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 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) [ Time Frame: 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).
- Generalized Anxiety Disorder 7-item Scale (GAD-7) [ Time Frame: 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) [ Time Frame: 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).
- PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Weeks 1, 9, 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064762
|Contact: Emma Turner, BAemail@example.com|
|Contact: Mark Powers, PhDfirstname.lastname@example.org|
|United States, Texas|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Contact: Mark Powers, PhD email@example.com|
|Contact: Emma Turner, BA firstname.lastname@example.org|
|Principal Investigator: Michael Foreman, MD|
|Sub-Investigator: Mark Powers, PhD|
|Principal Investigator:||Michael Kilgard, PhD||University of Texas at Dallas|
|Principal Investigator:||Robert Rennaker, PhD||University of Texas at Dallas|
|Study Director:||Seth Hays, PhD||University of Texas at Dallas|
|Principal Investigator:||Jane Wigginton, MD||University of Texas Southwestern Medical Center|
|Principal Investigator:||Michael Foreman, MD FACS||Baylor Health Care System|
|Study Director:||Mark Powers, PhD||Baylor Health Care System|