Combining a nerve block with therapy for PTSD in military personnel

Combining Stellate Ganglion Block With Prolonged Exposure for PTSD: A Randomized Clinical Trial

This study is testing if combining a nerve block with therapy can help military personnel and veterans with PTSD feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (Academic / other)
• Locations: 2 sites (Fort Hood, Texas and 1 other locations)
• Trial ID: NCT05889741 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of combining Massed Prolonged Exposure (PE), a behavioral therapy for PTSD, with a stellate ganglion block (SGB) in military service members and retirees diagnosed with PTSD. Participants will undergo ten 90-minute sessions of Massed PE, with half receiving an SGB and the other half receiving a sham injection between the first and second sessions. The study will assess treatment outcomes and psychophysiological responses to determine if the SGB enhances the effectiveness of the therapy. Assessments will occur at various intervals, including pretreatment, posttreatment, and follow-ups at 1, 3, and 6 months.

Who should consider this trial

Good fit: Ideal candidates are active duty or retired military service members aged 18-65 with a PTSD diagnosis.

Not a fit: Patients with severe suicidal ideation, current manic episodes, or significant substance use issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for military personnel suffering from PTSD.

How similar studies have performed: While the combination of SGB and behavioral therapy is a novel approach, similar studies have shown promising results in treating PTSD with various interventions.

Eligibility criteria

Inclusion Criteria:

1. Active duty and retired military service members ages 18-65 years
2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
3. Able to speak and read English (due to standardization of outcome measures)
4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.

Exclusion Criteria:

1. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
5. Pregnancy or breastfeeding
6. Current anticoagulant use
7. History of bleeding disorder
8. Infection or mass at injection site
9. Myocardial infarction within 6 months of procedure
10. Pathologic bradycardia or irregularities of heart rate or rhythm
11. Symptomatic hypotension
12. Phrenic or laryngeal nerve palsy
13. History of glaucoma
14. Uncontrolled seizure disorder
15. History of allergy to local anesthetics
16. Current use of Class III antiarrhythmics

Where this trial is running

Fort Hood, Texas and 1 other locations

• Carl R. Darnall Army Medical Center — Fort Hood, Texas, United States (Recruiting)
• University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Alan Peterson, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Amanda Flores

Conditions Stress Disorders, Post-Traumatic; SGB; Military