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Targeted Plasticity Therapy for Posttraumatic Stress Disorder

Primary Purpose

Post Traumatic Stress Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paired Vagus Nerve Stimulation
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Vagus Nerve Stimulation (VNS), Prolonged Exposure Therapy (PE), PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Patients diagnosed with chronic PTSD for at least 3 months based on the DSM-5 criteria (PSSI-5 score of 9-45)
  • 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

  • PSSI-5 score of 46 or greater (very severe symptoms)
  • 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

Sites / Locations

  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vagus Nerve Stimulation + Prolonged Exposure Therapy

Arm Description

Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
PTSD Checklist for DSM-5 (PCL-5)
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)
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)
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)
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).

Full Information

First Posted
July 31, 2019
Last Updated
January 4, 2023
Sponsor
Baylor Research Institute
Collaborators
Defense Advanced Research Projects Agency, The University of Texas at Dallas, University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04064762
Brief Title
Targeted Plasticity Therapy for Posttraumatic Stress Disorder
Official Title
Targeted Plasticity Therapy for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Defense Advanced Research Projects Agency, The University of Texas at Dallas, University of Texas Southwestern Medical Center

4. Oversight

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Vagus Nerve Stimulation (VNS), Prolonged Exposure Therapy (PE), PTSD, Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vagus Nerve Stimulation + Prolonged Exposure Therapy
Arm Type
Experimental
Arm Description
Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.
Intervention Type
Device
Intervention Name(s)
Paired Vagus Nerve Stimulation
Other Intervention Name(s)
VNS, vagus nerve stimulation, paired VNS
Intervention Description
Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events [Device Safety]
Description
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.
Time Frame
From Week 1 through study follow-up, approximately two years from the date of implant
Secondary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Description
The CAPS-5 is a 30-item structured PTSD diagnostic interview that measures PTSD symptoms. (Weathers, Bovin, Lee, et al. 2018).
Time Frame
Weeks 1, 9, 15, 19, 36, 62
Title
PTSD Checklist for DSM-5 (PCL-5)
Description
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).
Time Frame
Weeks 1, 9-15, 19, 36, 62
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
Weeks 1, 9-15, 19, 36, 62
Title
Generalized Anxiety Disorder 7-item Scale (GAD-7)
Description
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.
Time Frame
Weeks 9, 15, 19, 36, 62
Title
Posttraumatic Cognitions Inventory (PTCI)
Description
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).
Time Frame
Weeks 9-15, 19, 36, 62

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Patients diagnosed with chronic PTSD for at least 3 months based on the DSM-5 criteria (PSSI-5 score of 9-45) 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 PSSI-5 score of 46 or greater (very severe symptoms) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Kilgard, PhD
Organizational Affiliation
University of Texas at Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Rennaker, PhD
Organizational Affiliation
University of Texas at Dallas
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seth Hays, PhD
Organizational Affiliation
University of Texas at Dallas
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jane Wigginton, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Foreman, MD FACS
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Powers, PhD
Organizational Affiliation
Baylor Health Care System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard Naftalis, MD, FAANS, FACS
Organizational Affiliation
Baylor Health Care System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ann Marie Warren, PhD
Organizational Affiliation
Baylor Health Care System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jasper Smits, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Study Director
Facility Information:
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. 5th ed. Washington, DC: American Psychiatric Association; 2013.
Results Reference
background
PubMed Identifier
15609737
Citation
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.
Results Reference
background
PubMed Identifier
21228773
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
26691504
Citation
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.
Results Reference
background
PubMed Identifier
26691507
Citation
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.
Results Reference
background
PubMed Identifier
20855048
Citation
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. Erratum In: J Am Acad Child Adolesc Psychiatry. 2016 Oct;55(10):920.
Results Reference
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PubMed Identifier
22238857
Citation
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.
Results Reference
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PubMed Identifier
24309259
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
11556941
Citation
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.
Results Reference
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PubMed Identifier
20546985
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Targeted Plasticity Therapy for Posttraumatic Stress Disorder

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