Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Stress Disorders, Post-Traumatic

Treatments: Drug: Ropivacaine injection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04302181

HSC20190878H

Details and patient eligibility

About

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 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

Full 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 assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. The stellate ganglion block injection will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration.

During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Active duty or retired military service member (age 18- 65 years)
2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
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 Brooke Army Medical Center for the stellate ganglion block.

Exclusion criteria

1. Classification as high risk for suicide
2. Current serious mental health diagnosis (e.g., bipolar or psychosis)
3. Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
4. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
5. Current anticoagulant use
6. History of bleeding disorder
7. Infection or mass at injection site
8. Myocardial infarction within 6 months of procedure
9. Pathologic bradycardia or irregularities of heart rate or rhythm;
10. Symptomatic hypotension
11. Phrenic or laryngeal nerve palsy
12. History of glaucoma
13. Uncontrolled seizure disorder
14. History of allergy to local anesthetics

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Stellate Ganglion Block

Experimental group

Description:

One time administration of a stellate ganglion block

Treatment:

Drug: Ropivacaine injection