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Vagus Nerve Stimulation for Post-Traumatic Stress Disorder
Study Summary
This trial is testing a new device to help people with PTSD by stimulating the vagus nerve. The device is paired with exposure therapy, which is a type of therapy that helps people with PTSD by having them face their fears. The trial will assess the safety of the device and the therapy, and will also help researchers understand if the device and therapy are effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I am between 18 and 64 years old.I do not have major health issues like kidney failure or uncontrolled diabetes.I have an immunodeficiency or have been on drugs affecting my immune system in the last 6 months.You are currently feeling extremely sad and have thoughts of hurting yourself or have recently tried to hurt yourself.I have been diagnosed with chronic PTSD for over 3 months.I do not speak English.I am a suitable candidate for a vagus nerve stimulator implant.My symptoms are very severe, with a PSSI-5 score of 46 or more.I have health issues that make surgery risky for me.I don't have severe circulation issues that could affect a device being implanted.You have psychological conditions like schizophrenia, bipolar disorder, or psychosis that could make it difficult for you to participate in and keep up with the study.You are currently addicted to drugs or alcohol.I have significant brain injuries.I am willing and able to follow all study rules and be available for its duration.I have had or am currently undergoing vagus nerve stimulation treatment.I currently have active cancer.I am not on any treatments that would affect VNS therapy.You are currently receiving prolonged exposure therapy from another provider.You have had previous damage to your vagus nerve.
- Group 1: Vagus Nerve Stimulation + Prolonged Exposure Therapy
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this study permit octogenarians to participate?
"As per the stipulations of this clinical trial, participants must not exceed 64 years in age and should have surpassed 18."
Does this research offer enrollment opportunities for participants?
"As indicated by clinicaltrials.gov, this research project is still enrolling participants. It was initially listed on December 16th 2020 and its details were last modified on May 25th 2021."
Who is the ideal demographic for this research investigation?
"This clinical experiment is searching for 10 participants who have the corresponding ailment and are aged between 18 to 64."
What is the current enrollment cap for this clinical trial?
"Correct. According to clinicaltrials.gov, the medical trial which first opened its doors on December 16th 2020 is currently accepting candidates. There are 10 places available at one location for this study."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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