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RECRUITINGINTERVENTIONAL

Targeted Plasticity Therapy for PTSD

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

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

DEVICE

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

Locations (3)

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