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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 : September 17, 2019
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Baylor Research Institute

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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Device: Paired Vagus Nerve Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeted Plasticity Therapy for Posttraumatic Stress Disorder
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • VNS
  • vagus nerve stimulation
  • paired VNS




Primary Outcome Measures :
  1. Incidence of Serious Device Related Adverse Events [Device Feasibility] [ Time Frame: Week 35 (Six months post VNS+PE therapy intervention) ]
    Device will be considered safe if 25% or fewer participants experience a serious device related adverse event that requires the explant of the device.


Secondary Outcome Measures :
  1. Demographic Data [ Time Frame: Week 1 ]
    Participant demographic variables will be obtained through a standard self-report form or the patient's medical record at baseline and will include age, race, ethnicity, marital status, education level, employment, income, insurance status, veteran status, premorbid psychiatric history, and history of substance use.

  2. PTSD Symptom Scale for DSM-5 (PSSI-5) [ Time Frame: Week 1, 5, 11, 15, 23 ,35 ]
    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").

  3. MINI International Neuropsychiatric Interview (MINI) [ Time Frame: Week 5, 11, 15, 23, 35 ]
    The MINI is a structured clinical interview that has been effectively validated using the Structured Clinical Interview for DSM-III-R (SCID) and the Composite International Diagnostic Interview with good concordance (Hergueta et al., 1998). It assesses multiple diagnoses including Posttraumatic Stress Disorder, Major Depressive Depression, and Generalized Anxiety Disorder.

  4. Posttraumatic Diagnostic Scale for DSM-5 (PDS-5) [ Time Frame: Week 5-11, 15, 23, 35 ]
    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.

  5. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Week 5-11, 15, 23, 35 ]
    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.

  6. Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Week 5-11, 15, 23, 35 ]
    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).

  7. Generalized Anxiety Disorder 7-item Scale (GAD-7) [ Time Frame: Week 5, 11, 15, 23, 35 ]
    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.



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with PTSD based on the PSSI-5 interview
  • Appropriate candidate for VNS implantation
  • Male or female, 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
  • 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).
  • Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months
  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Mark Powers, PhD 214-865-2409 mark.powers1@bswhealth.org
Contact: Emma Turner, BA 214-865-2416 emma.turner@bswhealth.org

Locations
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United States, Texas
Baylor University Medical Center Not yet recruiting
Dallas, Texas, United States, 75246
Contact: Mark Powers, PhD       mark.powers1@bswhealth.org   
Contact: Emma Turner, BA       emma.turner@bswhealth.org   
Principal Investigator: Michael Foreman, MD         
Sub-Investigator: Mark Powers, PhD         
Sponsors and Collaborators
Baylor Research Institute
Defense Advanced Research Projects Agency
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Investigators
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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: Richard Naftalis, MD FAANS FACS Baylor Health Care System
Study Director: Mark Powers, PhD Baylor Health Care System
Study Director: Ann Marie Warren, PhD Baylor Health Care System

Publications:
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
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.
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.

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT04064762     History of Changes
Other Study ID Numbers: 019-280
N66001-15-2-4057 ( Other Grant/Funding Number: Defense Advanced Research Projects Agency (DARPA) )
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Baylor Research Institute:
Vagus Nerve Stimulation (VNS)
Prolonged Exposure Therapy (PE)
PTSD
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders