Combining Stellate Ganglion Block With Prolonged Exposure for PTSD

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889741
• Other study ID #: HSC20230087H
• Status: Recruiting
• Phase: Phase 2
• Start date: February 26, 2024
• Est. completion date: August 2026

Study information

• Verified date: February 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Amanda Flores
• Phone: 210-562-6726
• Email: floresa13[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.

Description:

Massed PE will be conducted by master-level or 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. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment.

The stellate ganglion block injection or the sham SGB 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.

Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic

Intervention

Drug:
• Ropivacaine injection
6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion
• Normal saline
6.5cc of Normal Saline one time into the stellate ganglion.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (7)

Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242. Erratum In: JAMA. 2018 Aug 21;320(7):724. — View Citation

Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402. — View Citation

Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available. — View Citation

Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518. — View Citation

Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151. — View Citation

Odosso RJ, Petta L. The Efficacy of the Stellate Ganglion Block as a Treatment Modality for Posttraumatic Stress Disorder Among Active Duty Combat Veterans: A Pilot Program Evaluation. Mil Med. 2021 Jul 1;186(7-8):e796-e803. doi: 10.1093/milmed/usaa246. — View Citation

Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; Consortium to Alleviate PTSD. Massed vs Intensive Outpatient Prolonged Exposure for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2249422. doi: 10.1001/jamanetworkopen.2022.49422. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)	A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis.	Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Primary	Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)	A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity.	Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Secondary	Patient Health Questionnaire-9 items (PHQ-9)	A 9-item self-report measure that assesses the presence and change in severity of depressive symptoms. Total scores range from 0 to 27 with higher scores reflective of greater severity.	Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Secondary	General Anxiety Disorder Screener - 7 Items (GAD-7)	A 9-item self-report measure that assesses the presence and change in severity of general anxiety symptoms. Total scores range from 0 to 21 with higher scores reflective of greater severity.	Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Secondary	Posttraumatic Cognitions Inventory (PTCI)	A 36-item self-report measure that assesses change in self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. Total scores range from 33 to 231 with higher scores reflective of more problematic cognitions.	Baseline and at 1-month, 3-month, and 6-month follow-up assessments
Secondary	Psychophysiological arousal - Galvanic Skin Response	Change in Psychophysiological data collected from a smart watch measuring galvanic skin response	Two weeks
Secondary	Psychophysiological arousal - Skin Temperature	Change in Psychophysiological data collected from a smart watch measuring skin temperature	Two weeks
Secondary	Psychophysiological arousal - Heart Rate	Change in Psychophysiological data collected from a smart watch measuring heart rate	Two weeks
Secondary	Psychophysiological arousal - Interbeat Interval	Change in Psychophysiological data collected from a smart watch measuring interbeat interval	Two weeks
Secondary	Psychophysiological arousal - Three-Dimensional Accelerometer Movement	Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement	Two weeks
Secondary	Psychophysiological arousal - Electrodermal Activity	Change in Psychophysiological data collected from a smart watch measuring electrodermal activity	Two weeks
Secondary	Psychophysiological arousal - Photoplethysmography	Change in Psychophysiological data collected from a smart watch measuring photoplethysmography	Two weeks