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| ID | Type | Description | Link |
|---|---|---|---|
| N66001-15-2-4057 | Other Grant/Funding Number | Defense Advanced Research Projects Agency (DARPA) |
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| Name | Class |
|---|---|
| Defense Advanced Research Projects Agency | FED |
| The University of Texas at Dallas | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vagus Nerve Stimulation + Prolonged Exposure Therapy | Experimental | Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paired Vagus Nerve Stimulation | Device | Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events [Device Safety] | 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. | From Week 1 through study follow-up, approximately two years from the date of implant |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | The CAPS-5 is a 30-item structured PTSD diagnostic interview that measures PTSD symptoms. (Weathers, Bovin, Lee, et al. 2018). | Weeks 1, 9, 15, 19, 36, 62 |
| PTSD Checklist for DSM-5 (PCL-5) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kilgard, PhD | The University of Texas at Dallas | Principal Investigator |
| Robert Rennaker, PhD | The University of Texas at Dallas | Principal Investigator |
| Seth Hays, PhD | The University of Texas at Dallas | Study Director |
| Jane Wigginton, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Michael Foreman, MD FACS | Baylor Health Care System | Principal Investigator |
| 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 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013. | ||
| 15609737 | Background | Corson K, Gerrity MS, Dobscha SK. Screening for depression and suicidality in a VA primary care setting: 2 items are better than 1 item. Am J Manag Care. 2004 Nov;10(11 Pt 2):839-45. | |
| 21228773 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 9, 2024 | Jun 5, 2024 | 16 |
| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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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).
| Weeks 1, 9-15, 19, 36, 62 |
| Patient Health Questionnaire-9 (PHQ-9) | 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. | Weeks 1, 9-15, 19, 36, 62 |
| Generalized Anxiety Disorder 7-item Scale (GAD-7) | 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. | Weeks 9, 15, 19, 36, 62 |
| Posttraumatic Cognitions Inventory (PTCI) | 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). | Weeks 9-15, 19, 36, 62 |
| Background |
| Engineer ND, Riley JR, Seale JD, Vrana WA, Shetake JA, Sudanagunta SP, Borland MS, Kilgard MP. Reversing pathological neural activity using targeted plasticity. Nature. 2011 Feb 3;470(7332):101-4. doi: 10.1038/nature09656. Epub 2011 Jan 12. |
| Background | Foa EB, Ehlers A, Clark DM, Tolin DF, Orsillo SM. The Posttraumatic Cognitions Inventory (PTCI): Development and validation. Psychol Assess 11(3): 303-314, 1999. |
| 26691504 | Background | Foa EB, McLean CP, Zang Y, Zhong J, Powers MB, Kauffman BY, Rauch S, Porter K, Knowles K. Psychometric properties of the Posttraumatic Diagnostic Scale for DSM-5 (PDS-5). Psychol Assess. 2016 Oct;28(10):1166-1171. doi: 10.1037/pas0000258. Epub 2015 Dec 21. |
| 26691507 | Background | Foa EB, McLean CP, Zang Y, Zhong J, Rauch S, Porter K, Knowles K, Powers MB, Kauffman BY. Psychometric properties of the Posttraumatic Stress Disorder Symptom Scale Interview for DSM-5 (PSSI-5). Psychol Assess. 2016 Oct;28(10):1159-1165. doi: 10.1037/pas0000259. Epub 2015 Dec 21. |
| 20855048 | Background | Gilboa-Schechtman E, Foa EB, Shafran N, Aderka IM, Powers MB, Rachamim L, Rosenbach L, Yadin E, Apter A. Prolonged exposure versus dynamic therapy for adolescent PTSD: a pilot randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2010 Oct;49(10):1034-42. doi: 10.1016/j.jaac.2010.07.014. Epub 2010 Sep 6. |
| 22238857 | Background | Goodson J, Helstrom A, Halpern JM, Ferenschak MP, Gillihan SJ, Powers MB. Treatment of posttraumatic stress disorder in U.S. combat veterans: a meta-analytic review. Psychol Rep. 2011 Oct;109(2):573-99. doi: 10.2466/02.09.15.16.PR0.109.5.573-599. |
| 24309259 | Background | Hays SA, Rennaker RL, Kilgard MP. Targeting plasticity with vagus nerve stimulation to treat neurological disease. Prog Brain Res. 2013;207:275-99. doi: 10.1016/B978-0-444-63327-9.00010-2. |
| Background | Hembree EA, Rauch SAM, Foa EB. Beyond the manual: The insider's guide to Prolonged Exposure therapy for PTSD. Cogn Behav Pract 10(1): 22-30, 2003. |
| 11556941 | Background | Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. |
| 20546985 | Background | Powers MB, Halpern JM, Ferenschak MP, Gillihan SJ, Foa EB. A meta-analytic review of prolonged exposure for posttraumatic stress disorder. Clin Psychol Rev. 2010 Aug;30(6):635-41. doi: 10.1016/j.cpr.2010.04.007. Epub 2010 May 2. |
| 9881538 | Background | Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. |
| 16717171 | Background | Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. |
| 40097094 | Derived | Powers MB, Hays SA, Rosenfield D, Porter AL, Gallaway H, Chauvette G, Smits JAJ, Warren AM, Douglas M, Naftalis R, Wigginton JG, Foreman M, Kilgard MP, Rennaker RL. Vagus nerve stimulation therapy for treatment-resistant PTSD. Brain Stimul. 2025 May-Jun;18(3):665-675. doi: 10.1016/j.brs.2025.03.007. Epub 2025 Mar 15. |