PTSD Trial, Recruiting NCT06266364 Sponsor: The University of Texas at Dallas Condition: PTSD
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PTSD Trial, Recruiting

NCT06266364
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with chronic PTSD (post-traumatic stress disorder) for at least 3 months, based on standard medical criteria
  • In the lead doctor's opinion, at least one standard, recommended PTSD treatment has not worked well enough for you
  • Your score on a standard PTSD symptom questionnaire (called the PCL-5) is greater than 33
  • You are between 22 and 79 years old
  • A doctor has determined you are a suitable candidate for a small device to be surgically implanted
  • You are willing and able to follow all the study requirements
  • You are able to understand and sign a consent form agreeing to take part

Who may not be able to join:

  • You are currently receiving a specific type of therapy called prolonged exposure therapy somewhere else
  • You are currently taking part in another clinical trial that involves a treatment or procedure
  • You have had a previous injury to the vagus nerve (a major nerve in the neck and body)
  • You have previously had, or are currently receiving, vagus nerve stimulation treatment
  • You have a mental health condition or thinking/memory problem that would make it difficult to take part, as decided by a doctor
  • You are considered to be at moderate or high risk of suicide, based on a standard assessment tool
  • You have a medical or personal situation that the lead doctor believes could put you at significant risk, make it unlikely you would complete the study, or affect the reliability of the study results (confirm with trial site)
  • Your neck measurement is larger than 18.5 inches around
  • You are a woman who could become pregnant and are currently pregnant, planning to become pregnant, or unwilling to use an accepted form of birth control during the study
  • You do not speak English
  • You are currently in prison or held in legal detention, as determined by the lead doctor

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 16 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jane Wigginton, MD, The University of Texas at Dallas

Phone: 972-883-7256

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
The University of Texas at Dallas
Registry
ClinicalTrials.gov
Start date
30 December 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

ReStore System Safety

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 16 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov