Status:
COMPLETED
Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
United States Department of Defense
Conditions:
Stress Disorders, Post-Traumatic
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief Summary
This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 partic...
Detailed Description
Massed PE will be conducted by doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment a...
Eligibility Criteria
Inclusion
- Active duty or retired military service member (age 18- 65 years)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.
Exclusion
- Classification as high risk for suicide
- Current serious mental health diagnosis (e.g., bipolar or psychosis)
- Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
- Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
- Current anticoagulant use
- History of bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm;
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04302181
Start Date
October 5 2020
End Date
December 3 2021
Last Update
September 9 2022
Active Locations (2)
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1
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229