Status:
ACTIVE_NOT_RECRUITING
Targeted Plasticity Therapy for Posttraumatic Stress Disorder
Lead Sponsor:
Baylor Research Institute
Collaborating Sponsors:
Defense Advanced Research Projects Agency
The University of Texas at Dallas
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
Posttraumatic stress disorder is a debilitating condition that develops in the aftermath of a traumatic experience, leading to hyperarousal, heightened anxiety, and uncontrolled fear that can be drive...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
December 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04064762
Start Date
December 16 2020
End Date
April 1 2024
Last Update
January 5 2023
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246