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Non-Invasive Vagus Nerve Stimulation for Post-Traumatic Stress Disorder (taVNS Trial)
taVNS Trial Summary
This trial will study whether a non-invasive vagus nerve stimulator can help people with PTSD from the World Trade Center respond better to treatment.
taVNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowtaVNS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.taVNS Trial Design
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Who is running the clinical trial?
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- My blood pressure is not controlled by medication.I have not been hospitalized for another illness in the last 30 days.I have had surgery to cut the nerves to my stomach.I have been diagnosed with PTSD by a professional using the CAPS assessment.I have a history of seizures or currently experience them.I am able to understand and agree to participate in the study.I have been diagnosed with PTSD according to the DSM.I was diagnosed with cancer, excluding non-invasive skin cancer or cervical carcinoma in-situ, within the last 5 years.I do not have any significant ongoing health issues apart from my current condition.You are currently experiencing severe mental health symptoms, such as hallucinations or extreme mood swings, or have a substance addiction.I have had serious heart issues or uncontrolled high blood pressure recently.You have shown signs of severe post-traumatic stress disorder (PTSD) based on a score higher than 44 on a questionnaire during an annual check-up between 2018 and 2020.I have a history of fainting spells due to sudden drops in heart rate and blood pressure.I am currently taking medication for mental health issues.I do not have ear problems that would stop me from using an earpiece daily.
- Group 1: taVNS Treatment
- Group 2: Sham Comparator
- 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
To what capacity has this experiment been populated?
"Affirmative. Information on clinicaltrials.gov indicates that this research project is in the process of recruiting participants and was initially posted on March 31st 2022, with a subsequent update made April 1st 2022. 30 individuals are required to be recruited from one centre for participation."
What outcomes does this medical trial hope to accomplish?
"This experiment, to be assessed over an 8 week period, seeks to explore the practicality of utilising taVNS with WTCHP Responders as measured by recruitment rates. Further metrics include acceptability (refusal rate, time-to-completion and percentage missing data) between taVNS and sham groups which will be described using frequency/percentage or mean values along with corresponding 95% confidence intervals for precision."
Are there any enrollment slots currently available for this research endeavor?
"Affirmative. According to the clinicaltrials.gov records, this clinical trial is actively enrolling participants who meet their criteria. It was first announced on March 31st 2022 and last modified on April 1st 2022; 30 patients are needed at a single medical centre for its completion."
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