Recruiting

Targeted Plasticity Therapy

Sponsor:

The University of Texas at Dallas

Code:

NCT06266364

Conditions

PTSD, Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Active VNS stimulation

Sham VNS stimulation

Study Details

Brief summary:

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

Study ID

NCT06266364

Start date

Dec 30, 2024

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
2. In the medical opinion of the Principal Investigator (PI), failed at least one adequate course of first-line PTSD treatment per American Psychological Association (APA) 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.

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Immediate VNS Group

The participants in this arm will be implanted with the device and will receive active VNS stimulations in phase 1 as well as phase 2 of the study.

sham comparator: Delayed VNS Group

The participants in this arm will be implanted with the device but will receive sham VNS stimulations in phase 1 of the study and active VNS in phase 2 of the study.

Interventions

Active VNS stimulation

The subjects in this group will be implanted with the ReStore device and receive active Vagus nerve stimulation (VNS) in phase 1

Sham VNS stimulation

The subjects in this group will be implanted with the ReStore device and receive sham Vagus nerve stimulation (VNS) in phase 1

Primary outcome measure

  • ReStore System Safety [ Time Frame: From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first ]

Central Contacts and Locations

Locations

The University of Texas Health Austin Ambulatory Surgery Center

Recruiting

Austin, Texas, United States, 78712

Baylor University Medical Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Texas Biomedical Device Center

Recruiting

Richardson, Texas, United States, 75080

Contacts

Amy Porter

972-883-7256

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • 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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2026-06-08.