Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baylor Research Institute
With
Defense Advanced Research Projects Agency
The University of Texas at Dallas
University of Texas Southwestern Medical Center
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients diagnosed with chronic PTSD for at least 3 months based on the DSM-5 criteria (PSSI-5 score of 9-45)
Appropriate candidate for VNS implantation
Adult, aged 18-64
Provision of signed and dated informed consent form
Willingness to comply with all study procedures and availability for the duration of the study
Right vocal cord has normal movement when assessed by laryngoscopy
Women of reproductive potential must use contraceptive protection
You may not be if
PSSI-5 score of 46 or greater (very severe symptoms)
Current substance dependence
Currently undergoing prolonged exposure therapy elsewhere
Concomitant clinically significant brain injuries
Prior injury to vagus nerve
Prior or current treatment with vagus nerve stimulation
Participant receiving any therapy (medication or otherwise) that would interfere with VNS
Planning to become pregnant, currently pregnant, or lactating
Clinical complications that hinder or contraindicate the surgical procedure
Cognitive impairment that would interfere with study participation, confirmed by medical evaluation (will be assessed through chart review and with the Cognistat)
Psychological conditions such as schizophrenia, bipolar disorder, or psychosis that could interfere with study participation and follow-up
Participation in other interventional clinical trial
Participants with known immunodeficiency including participants who are receiving or have received chronic corticosteroids, immunosuppressants, immunostimulating agents or radiation therapy within 6 months
Significant comorbidities or conditions associated with high risk for surgical or anesthetic survival (e.g. renal failure, unstable cardiac disease, poorly controlled diabetes, immunosuppression, etc.).
Active neoplastic disease.
Significant local circulatory problems that would interfere with device implantation and communication, (e.g. thrombophlebitis and lymphedema).
Any condition which, in the judgment of the Investigator, would preclude adequate evaluation of device's safety and performance.
Incarceration or legal detention
Non-English speaking
Patients who are acutely suicidal and/or have been admitted for a suicide attempt
Clareo Health | Targeted Plasticity Therapy for Posttraumatic Stress Disorder
