Targeted Plasticity Therapy for Posttraumatic Stress Disorder
NCT ID: NCT04064762
Last Updated: 2023-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
9 participants
INTERVENTIONAL
2020-12-16
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Vagus Nerve Stimulation + Prolonged Exposure Therapy
Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.
Paired Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
Interventions
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Paired Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Appropriate candidate for VNS implantation
* Adult, aged 18-64
* Provision of signed and dated informed consent form
* Willingness to comply with all study procedures and availability for the duration of the study
* Right vocal cord has normal movement when assessed by laryngoscopy
* Women of reproductive potential must use contraceptive protection
Exclusion Criteria
* Current substance dependence
* Currently undergoing prolonged exposure therapy elsewhere
* Concomitant clinically significant brain injuries
* Prior injury to vagus nerve
* Prior or current treatment with vagus nerve stimulation
* Participant receiving any therapy (medication or otherwise) that would interfere with VNS
* Planning to become pregnant, currently pregnant, or lactating
* Clinical complications that hinder or contraindicate the surgical procedure
* Cognitive impairment that would interfere with study participation, confirmed by medical evaluation (will be assessed through chart review and with the Cognistat)
* Psychological conditions such as schizophrenia, bipolar disorder, or psychosis that could interfere with study participation and follow-up
* Participation in other interventional clinical trial
* Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months
* Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
* Active neoplastic disease.
* Significant local circulatory problems that would interfere with device implantation and communication, (e.g. thrombophlebitis and lymphedema).
* Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
* Incarceration or legal detention
* Non-English speaking
* Patients who are acutely suicidal and/or have been admitted for a suicide attempt
18 Years
64 Years
ALL
No
Sponsors
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Defense Advanced Research Projects Agency
FED
The University of Texas at Dallas
OTHER
University of Texas Southwestern Medical Center
OTHER
Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Michael Kilgard, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
Robert Rennaker, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
Seth Hays, PhD
Role: STUDY_DIRECTOR
University of Texas at Dallas
Jane Wigginton, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Michael Foreman, MD FACS
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
Mark Powers, PhD
Role: STUDY_DIRECTOR
Baylor Health Care System
Richard Naftalis, MD, FAANS, FACS
Role: STUDY_DIRECTOR
Baylor Health Care System
Ann Marie Warren, PhD
Role: STUDY_DIRECTOR
Baylor Health Care System
Jasper Smits, PhD
Role: STUDY_DIRECTOR
The University of Texas at Austin
Locations
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Baylor University Medical Center
Dallas, Texas, United States
Countries
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References
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American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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N66001-15-2-4057
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
019-280
Identifier Type: -
Identifier Source: org_study_id
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