Search / Trial NCT06234969

A Mechanistic Trial of the Neurobiology of Extinction Learning and Intraparietal Sulcus Stimulation

Launched by UNIVERSITY OF PENNSYLVANIA · Jan 22, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help people with posttraumatic stress disorder (PTSD) feel less anxious and startled. Researchers want to see if a treatment called continuous theta burst stimulation (cTBS) can help reduce arousal symptoms, which are feelings of heightened anxiety and startle responses. The trial will compare the effects of real cTBS to a placebo (sham cTBS) and check if combining cTBS with a type of therapy called extinction training can make the treatment even more effective. The goal is to find out how well cTBS works and whether different doses have a greater impact on reducing symptoms.

To be eligible for this study, participants must be adults aged 18 to 60 who have been diagnosed with PTSD. They should not have any metal implants, seizure disorders, or certain other medical conditions that might interfere with the treatment. If you join the study, you can expect to receive either the real treatment or a placebo, and you will be monitored throughout the process. This research is important because it could lead to new ways to help people manage their PTSD symptoms and improve their quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult aged 18-60
  • Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD according to the Clinician-Administered PTSD Scale for DSM-5
  • No metal implants
  • Exclusion Criteria:
  • Pregnancy
  • Seizure disorder or epilepsy
  • Increased risk of seizure
  • Non-English speaking
  • Any medical condition that increases risk for fMRI or cTBS
  • Medical implant
  • Hearing loss sufficient to interfere with startle
  • Claustrophobia
  • Recent medication or therapy changes (in the past 8 weeks)
  • Current severe substance use disorder

Trial Officials

Lily A Brown, PhD

Principal Investigator

University of Pennsylvania

About University Of Pennsylvania

The University of Pennsylvania, a prestigious Ivy League institution located in Philadelphia, is renowned for its commitment to advancing medical research and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its extensive resources, interdisciplinary expertise, and cutting-edge facilities to conduct innovative studies across various therapeutic areas. With a focus on translating scientific discoveries into clinical applications, the University of Pennsylvania fosters collaborations among leading researchers, clinicians, and industry partners, ensuring rigorous trial design and adherence to ethical standards. Through its dedication to excellence in research and education, the university plays a pivotal role in shaping the future of medicine.

Locations

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0