Stellate Ganglion Block to Augment Trauma-focused Therapy Among Veterans With PTSD

NCT05107752 | Completed Phase 2 FDA Drug

• 1 other identifier: 2021H0228
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD). The primary objective of this project is to examine if stellate ganglion block (SGB) improves outcomes among military personnel and veterans receiving cognitive processing therapy (CPT), an empirically-supported psychological treatment for PTSD. To accomplish this objective, we will enroll adult military personnel and veterans with a current diagnosis of PTSD and/or subthreshold PTSD, provide CPT sessions over two weeks, administer SGB during or after CPT, and repeatedly assess key outcomes during follow-up.

Conditions

PTSD; Trauma and Stressor Related Disorders; Trauma, Psychological; Post Traumatic Stress Disorder

Keywords

veteran; military; stellate ganglion block; cognitive processing therapy; cognitive behavioral therapy

Outcome Measures

Primary Outcomes (1)

• Change in PTSD symptom severity

  PTSD symptom severity will be assessed using PTSD PCL-5. The scale includes 20 items that rate the severity of each symptom using a 5-point scale, with items summed to provide an overall metric of PTSD symptom severity.

  Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52

Secondary Outcomes (4)

• Change in depression symptom severity

  Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52

• Change in anxiety symptom severity

  Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52

• Change in somatic symptoms

  Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52

• Change in good end-state functioning

  Screening, Week 0, Week 1, Week 2, Week 4, Week 8, Week 12, Week 13, Week 14, Week 16, Week 20, Week 24, Week 52

Study Arms (2)

Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)

EXPERIMENTAL

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Behavioral: Cognitive Processing Therapy (CPT); Drug: Stellate Ganglion Block

SGB three months after completing CPT

EXPERIMENTAL

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

Behavioral: Cognitive Processing Therapy (CPT); Drug: Stellate Ganglion Block

Interventions

Cognitive Processing Therapy (CPT) BEHAVIORAL

Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.

SGB three months after completing CPT; Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)

Stellate Ganglion Block DRUG

SGB is a procedure that has demonstrated efficacy for the reduction of PTSD symptoms. SGB is performed using real-time ultrasonography with an in-plane technique, and consists of 7-10 mL of ropivacaine 0.5%, which is injected around and into the site of the ganglion at the level of the C4 and C6 anterior tubercle (Mulvaney, Curtis et al., 2020). Ropivacaine is a long-acting amide local anesthetic agent and a pure S-enantiomer with a high pKa and relatively low solubility. Patients are not sedated during the procedure. Successful sympathetic blockade is confirmed by the presence of Horner's syndrome, which is characterized by constriction of the pupil (miosis) and drooping of the upper eyelid (ptosis). If Horner's syndrome is not observed within 20 minutes of the first injection, the right-sided SGB is repeated one hour later using the same technique. If Horner's syndrome is not confirmed after the second injection, no additional injections are provided.

SGB three months after completing CPT; Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Prior or current service in the U.S. military
• Diagnosis of PTSD within the last month
• Ability to speak and understand the English language
• Stable psychotropic medication dosing for at least 3 months
• Ability to complete the informed consent process

You may not qualify if:

• Prior SGB treatment or CPT treatment
• History of schizophrenia, another psychotic disorder, or bipolar disorder
• Moderate or severe traumatic brain injury
• Moderate or severe symptoms of a substance use disorder within the preceding 30 days
• Severe suicide risk warranting suicide-focused treatment and/or inpatient hospitalization
• Impaired mental status that precludes the ability to provide informed consent
• Any ongoing stressor or condition deemed by the investigators to place the participant at risk for injury or a poor outcome

Sponsors & Collaborators

• Ohio State University: lead
• The Stellate Institute: collaborator
• Navy SEAL Foundation: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (17)

• Alino J, Kosatka D, McLean B, Hirsch K. Efficacy of stellate ganglion block in the treatment of anxiety symptoms from combat-related post-traumatic stress disorder: a case series. Mil Med. 2013 Apr;178(4):e473-6. doi: 10.7205/MILMED-D-12-00386.

  PMID: 23707834 BACKGROUND

• Harik, J. M., Grubbs, K. G., & Schnurr, P. P. (2016, November). Using graphics to communicate information about PTSD treatment effectiveness to patients. In J. L. Hamblen (Chair), Enhancing the quality of online information to support PTSD treatment engagement. Symposium presented at the 30th annual meeting of the International Society for Traumatic Stress Studies in Dallas, TX.

  BACKGROUND

• Hicky A, Hanling S, Pevney E, Allen R, McLay RN. Stellate ganglion block for PTSD. Am J Psychiatry. 2012 Jul;169(7):760. doi: 10.1176/appi.ajp.2012.11111729. No abstract available.

  PMID: 22760192 BACKGROUND

• Hoge CW, Castro CA, Messer SC, McGurk D, Cotting DI, Koffman RL. Combat duty in Iraq and Afghanistan, mental health problems, and barriers to care. N Engl J Med. 2004 Jul 1;351(1):13-22. doi: 10.1056/NEJMoa040603.

  PMID: 15229303 BACKGROUND

• Hoge CW, Terhakopian A, Castro CA, Messer SC, Engel CC. Association of posttraumatic stress disorder with somatic symptoms, health care visits, and absenteeism among Iraq war veterans. Am J Psychiatry. 2007 Jan;164(1):150-3. doi: 10.1176/ajp.2007.164.1.150.

  PMID: 17202557 BACKGROUND

• Jakupcak M, Conybeare D, Phelps L, Hunt S, Holmes HA, Felker B, Klevens M, McFall ME. Anger, hostility, and aggression among Iraq and Afghanistan War veterans reporting PTSD and subthreshold PTSD. J Trauma Stress. 2007 Dec;20(6):945-54. doi: 10.1002/jts.20258.

  PMID: 18157891 BACKGROUND

• 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.

  PMID: 19034755 BACKGROUND

• 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.

  PMID: 27612365 BACKGROUND

• McLean B. Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. Cureus. 2015 Sep 10;7(9):e320. doi: 10.7759/cureus.320.

  PMID: 26487996 BACKGROUND

• Milliken CS, Auchterlonie JL, Hoge CW. Longitudinal assessment of mental health problems among active and reserve component soldiers returning from the Iraq war. JAMA. 2007 Nov 14;298(18):2141-8. doi: 10.1001/jama.298.18.2141.

  PMID: 18000197 BACKGROUND

• Mulvaney SW, Curtis KE, Ibrahim TS (2020) Comparison C6 Stellate Ganglion versus C6 and C4 Cervical Sympathetic Chain Blocks for Treatment of Posttraumatic Stress Disorder (PTSD): Analysis of 147 Patients. J Neurol Disord Stroke 7(3): 1163.

  BACKGROUND

• 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.

  PMID: 25269132 BACKGROUND

• Mulvaney SW, McLean B, de Leeuw J. The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. Pain Pract. 2010 Jul-Aug;10(4):359-65. doi: 10.1111/j.1533-2500.2010.00373.x. Epub 2010 Apr 20.

  PMID: 20412504 BACKGROUND

• Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.

  PMID: 31693083 BACKGROUND

• Panagioti M, Gooding P, Tarrier N. Post-traumatic stress disorder and suicidal behavior: A narrative review. Clin Psychol Rev. 2009 Aug;29(6):471-82. doi: 10.1016/j.cpr.2009.05.001. Epub 2009 Jun 8.

  PMID: 19539412 BACKGROUND

• Tanielian, T., & Jaycox, L.H. (2008). Invisible Wounds of War. Rand Corporation, 1-66.

  BACKGROUND

• Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.

  PMID: 23842024 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders

Study Officials

• Craig J Bryan, PsyD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stress, Trauma, and Resilience (STAR) Professor

Model Details: All participants receive cognitive processing therapy during weeks 1 and 2. Participants will be randomly allocated to receive SGB during or 3 months after CPT.

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 4, 2021
• Study Start: January 3, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting 6 months after publication of primary results
• Access Criteria: All requests for data and/or code use will be reviewed by the PIs and co-Is and a majority vote will be used to determine whether the request is approved or not. If the request is approved, Dr. Bryan will inform the requestor, return a signed copy of the completed Data Use Request Form to the requestor, and let the requestor know that written IRB approval of the requestor's proposed study from the requestor's home institution will be required before data and/or code will be shared with the requestor. If a request is approved pending revision to the Data Use Request Form, Dr. Bryan will work with requestors to revise sections of their Data Use Request Forms in order to obtain approval. If the request is not approved, Dr. Bryan will inform the requestor and returned a signed copy of the completed Data Use Request Form to the requestor that includes an explanation for the denial.

Locations

US (1)