RECRUITING

Targeted Plasticity Therapy for PTSD

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Conditions

PTSD, Post Traumatic Stress DisorderPTSD, Post-Traumatic Stress DisorderVNS, Vagus Nerve StimulationTPT, Targeted Plasticity TherapyReStore SystemPE, Prolonged Exposure TherapyTrauma and Stressor Related DisordersMental DisordersStress Disorders, TraumaticStress Disorders, Post-Traumatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Objectives of this study are to provide continued safety assessment for the ReStore system, and to gain further estimates of the effect size of Vagus Nerve Stimulation (VNS) therapy with Prolonged Exposure Therapy (PE) compared to PE with placebo (sham) stimulation in participants with posttraumatic stress disorder (PTSD)

Official Title

Targeted Plasticity Therapy for the Treatment of Post-Traumatic Stress Disorder

Quick Facts

Study Start:2024-12-11
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06266364

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 79 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
  2. 2. Failed at least one standard first-line PTSD treatment per APA (American Psychological Association) guidelines
  3. 3. PCL-5 score greater than 33
  4. 4. Age 22-79 years
  5. 5. Appropriate surgical candidate for VNS device implantation
  6. 6. Willing and able to comply with study protocol
  7. 7. Able to provide informed consent.
  1. 1. Currently undergoing prolonged exposure therapy elsewhere
  2. 2. Concurrent participation in another interventional clinical trial
  3. 3. Prior injury to vagus nerve
  4. 4. Prior or current treatment with vagus nerve stimulation
  5. 5. Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
  6. 6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
  7. 7. Persons with a current or past: (a) medical (psychiatric, non-psychiatric) condition, disease, disorder, injury, or disability or (b) non-medical situation or circumstance that, in the opinion of the principal investigator, study participation:
  8. * may pose a significant or undue risk to the person,
  9. * make it unlikely the person will complete all the study requirements per protocol, or
  10. * may adversely impact the integrity of the data or the validity of the study results
  11. 8. Persons with a neck circumference larger than 18.5 inches
  12. 9. Females of childbearing potential who are either pregnant or planning to become pregnant and who are not using, or will not agree to use medically acceptable birth control methods
  13. 10. Non-English speaking
  14. 11. As determined by the principal investigator, is under current incarceration or legal detention

Contacts and Locations

Study Contact

Amy Porter
CONTACT
972-883-7256
alp160730@utdallas.edu
Katharine Dlouhy
CONTACT
972-883-7231
katharine.dlouhy@utdallas.edu

Principal Investigator

Jane Wigginton, MD
PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
Robert Rennaker, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas
Jasper Smits, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Mark Powers, PhD
PRINCIPAL_INVESTIGATOR
Baylor Scott & White
Michael Kilgard, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas at Dallas

Study Locations (Sites)

The University of Texas Health Austin Ambulatory Surgery Center
Austin, Texas, 78712
United States
Baylor University Medical Center
Dallas, Texas, 75246
United States
Texas Biomedical Device Center
Richardson, Texas, 75080
United States

Collaborators and Investigators

Sponsor: The University of Texas at Dallas

  • Jane Wigginton, MD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas
  • Robert Rennaker, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas
  • Jasper Smits, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas at Austin
  • Mark Powers, PhD, PRINCIPAL_INVESTIGATOR, Baylor Scott & White
  • Michael Kilgard, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas at Dallas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-11
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12-11
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • PTSD, Post-Traumatic Stress Disorder
  • VNS, Vagus Nerve Stimulation
  • TPT, Targeted Plasticity Therapy
  • ReStore System
  • PE, Prolonged Exposure Therapy
  • Trauma and Stressor Related Disorders
  • Mental Disorders
  • Stress Disorders, Traumatic
  • Stress Disorders, Post-Traumatic

Additional Relevant MeSH Terms

  • PTSD, Post Traumatic Stress Disorder