Targeted Plasticity Therapy for Posttraumatic Stress Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04064762|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : September 30, 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 :||October 2020|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 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 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.
- 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, 9-15, 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).
- 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
|Study Director:||Richard Naftalis, MD, FAANS, FACS||Baylor Health Care System|
|Study Director:||Ann Marie Warren, PhD||Baylor Health Care System|
|Study Director:||Jasper Smits, PhD||The University of Texas at Austin|