Could a pacemaker for the vagus nerve ease PTSD?
NCT ID NCT06266364
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This early study tests whether a surgically implanted device that stimulates the vagus nerve can boost the effects of talk therapy for people with chronic PTSD. Twenty adults who have not gotten better with standard treatments will receive either active or sham stimulation alongside prolonged exposure therapy. The main goal is to check safety, but researchers will also measure changes in PTSD symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vagus nerve stimulation (VNS) device
- What this could lead to
- If it works, this could point toward a more effective treatment for PTSD by combining nerve stimulation with talk therapy.
- What could go wrong
- This is a very small early safety trial with only 20 people. It may not show clear benefit, and the device requires surgical implantation, which carries risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Baylor University Medical Center
RECRUITINGDallas, Texas, 75246, United States
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Texas Biomedical Device Center
RECRUITINGRichardson, Texas, 75080, United States
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The University of Texas Health Austin Ambulatory Surgery Center
RECRUITINGAustin, Texas, 78712, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- One-Day brain zaps plus antibiotic could rewire PTSD in first responders
- Virtual reality could open doors to trauma therapy
- Faith-Based therapy aims to heal trauma in young women
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