Targeted Plasticity Therapy for PTSD

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)

Conditions

PTSD, Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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)

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

Targeted Plasticity Therapy for PTSD

Condition
PTSD, Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

Austin

The University of Texas Health Austin Ambulatory Surgery Center, Austin, Texas, United States, 78712

Dallas

Baylor University Medical Center, Dallas, Texas, United States, 75246

Richardson

Texas Biomedical Device Center, Richardson, Texas, United States, 75080

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
  • 2. Failed at least one standard first-line PTSD treatment per APA (American Psychological Association) guidelines
  • 3. PCL-5 score greater than 33
  • 4. Age 22-79 years
  • 5. Appropriate surgical candidate for VNS device implantation
  • 6. Willing and able to comply with study protocol
  • 7. Able to provide informed consent.
  • 1. Currently undergoing prolonged exposure therapy elsewhere
  • 2. Concurrent participation in another interventional clinical trial
  • 3. Prior injury to vagus nerve
  • 4. Prior or current treatment with vagus nerve stimulation
  • 5. Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
  • 6. Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
  • 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:
  • * may pose a significant or undue risk to the person,
  • * make it unlikely the person will complete all the study requirements per protocol, or
  • * may adversely impact the integrity of the data or the validity of the study results
  • 8. Persons with a neck circumference larger than 18.5 inches
  • 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
  • 10. Non-English speaking
  • 11. As determined by the principal investigator, is under current incarceration or legal detention

Ages Eligible for Study

22 Years to 79 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2026-06