Targeted Plasticity Therapy for PTSD

NCT06266364 | Recruiting DMC FDA Device

• 3 other identifiers: IRB-24-22HT94252310818175181
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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

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

Outcome Measures

Primary Outcomes (1)

• ReStore System Safety

  ReStore System safety by review of any adverse events

  From surgery to up to 2 years following implantation or until the device is FDA approved, whichever comes first

Secondary Outcomes (5)

• Clinician Administered PTSD Scale for DSM-5(fifth edition of the Diagnostic and Statistical Manual of Mental Disorders)(CAPS-5)

  From baseline up to visit 33 (end of study)

• PTSD Checklist for DSM-5 (PCL-5) score

  From baseline up to visit 33 (end of study)

• PostTraumatic Cognitions Inventory (PTCI)

  From baseline up to visit 33 (end of study)

• Generalized Anxiety Disorder 7-item Scale (GAD-7)

  From baseline up to visit 33 (end of study)

• Patient Health Questionnaire-9 (PHQ-9)

  From baseline up to visit 33 (end of study)

Study Arms (2)

Immediate VNS Group

ACTIVE COMPARATOR

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.

Device: Active VNS stimulation

Delayed VNS Group

SHAM COMPARATOR

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.

Device: Sham VNS stimulation

Interventions

Active VNS stimulation DEVICE

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

Immediate VNS Group

Sham VNS stimulation DEVICE

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

Delayed VNS Group

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic PTSD for at least 3 months based on DSM-5 criteria
• 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
• PCL-5 score greater than 33
• Age 22-79 years
• Appropriate surgical candidate for VNS device implantation
• Willing and able to comply with study protocol
• Able to provide informed consent.

You may not qualify if:

• Currently undergoing prolonged exposure therapy elsewhere
• Concurrent participation in another interventional clinical trial
• Prior injury to vagus nerve
• Prior or current treatment with vagus nerve stimulation
• Psychiatric disorders and/or cognitive impairments that would interfere with study participation, as assessed by medical evaluation
• Moderate-High Risk of Suicide according to Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version
• 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
• Persons with a neck circumference larger than 18.5 inches
• 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
• Non-English speaking
• As determined by the principal investigator, is under current incarceration or legal detention

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Congressionally Directed Medical Research Programs: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (3)

The University of Texas Health Austin Ambulatory Surgery Center

Austin, Texas, 78712, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

Texas Biomedical Device Center

Richardson, Texas, 75080, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders; Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic

Study Officials

• Jane Wigginton, MD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Robert Rennaker, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

• Jasper Smits, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

• Mark Powers, PhD

  Baylor Scott & White

  PRINCIPAL INVESTIGATOR

• Michael Kilgard, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Porter

CONTACT

972-883-7256; alp160730@utdallas.edu

Katharine Dlouhy

CONTACT

972-883-7231; katharine.dlouhy@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All are blinded in the RCT (Randomized Controlled Trial) phase. However, sites will need to have an unblinded programmer who is only programming the device and not collecting outcomes data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 1:1 randomization of active stimulation vs. sham stimulation for 12 sessions post randomization, followed by up to 12 sessions of open label active stimulation for all participants

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: February 20, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)