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New treatment option for PTSD, Post Traumatic Stress Disorder
Official title Targeted Plasticity Therapy for PTSD
ClinicalTrials.gov ID: NCT06266364
What this study is testing
- What it's testing
- 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)
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 79
You may be able to join 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...
- PCL-5 score greater than 33
- Age 22-79 years
- Appropriate surgical candidate for VNS device implantation
You likely can't join if
- Currently undergoing prolonged exposure therapy elsewhere
- Concurrent participation in another treatment 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
See the full eligibility criteria
- 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.
- Currently undergoing prolonged exposure therapy elsewhere
- Concurrent participation in another treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Austin, Texas, United States
- Dallas, Texas, United States
- Richardson, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 79 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Austin, Texas, United States; Dallas, Texas, United States; Richardson, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.