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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04302181
• Other study ID #: HSC20190878H
• Status: Completed
• Phase: Early Phase 1
• Start date: October 5, 2020
• Est. completion date: December 3, 2021

Study information

• Verified date: September 2022
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 3, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Ropivacaine injection
6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	Fort Sam Houston	Texas
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 (6)

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

Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017. Review. — 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. — 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CAPS-5 (Clinician-Administered PTSD Scale)	A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.	Baseline, 1 month and 3 months
Primary	Change in PCL-5 (Posttraumatic Stress Disorder Checklist)	A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5).	Baseline, 1 month and 3 months
Secondary	Change in PHQ-9 (Patient Health Questionnaire-9)	A 9-item self-report measure that assesses the presence and severity of depressive symptoms.	Baseline, 1 month and 3 months
Secondary	Change in Brief Inventory of Psychosocial Functioning	A 7-item self-report measure assessing respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living.	Baseline, 1 month and 3 months
Secondary	Change in GAD-7 (General Anxiety Disorder Screener)	A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms.	Baseline, 1 month and 3 months
Secondary	Change in PTCI (Posttraumatic Cognitions Inventory)	A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure.	Baseline, 1 month and 3 months