Stellate Ganglion Block + Therapy for PTSD

Overseen By Tabatha Blount, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Anticoagulants, Class III antiarrhythmics

Disqualifiers: Suicidal ideation, Manic episode, Substance use, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 2 weeks

140 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anticoagulants or Class III antiarrhythmics.

What data supports the effectiveness of the treatment Stellate Ganglion Block + Therapy for PTSD?

Research shows that stellate ganglion block (SGB), which involves injecting a local anesthetic like ropivacaine into the neck, has been successfully used to reduce symptoms of PTSD in several studies, including cases with combat-related PTSD. This treatment has been effective in providing immediate relief from anxiety symptoms associated with PTSD. ^{1 2 3 4 5}

Is Stellate Ganglion Block (SGB) safe for humans?

The Stellate Ganglion Block (SGB) procedure, which involves an injection in the neck to help manage stress responses, has been studied for safety and patient acceptability in treating PTSD symptoms. It is generally considered safe as an outpatient procedure, with studies focusing on its use in military personnel with PTSD. ^{2 3 4 5 6}

How does the stellate ganglion block treatment for PTSD differ from other treatments?

Stellate ganglion block (SGB) is unique because it involves an injection of a local anesthetic in the neck to temporarily block nerves that control the body's fight-or-flight response, providing immediate relief from PTSD symptoms. Unlike traditional PTSD treatments, SGB is a quick outpatient procedure with minimal side effects and has been used successfully for other conditions like chronic pain. ^{1 2 3 4 5}

Research Team

Alan Peterson, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for active duty and retired military service members aged 18-65 with PTSD, who can speak and read English. They must be eligible to receive care at a military treatment facility where the neck injection will take place.

Inclusion Criteria

I have been diagnosed with PTSD by a professional.

Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.

Able to speak and read English (due to standardization of outcome measures)

Exclusion Criteria

I am currently taking blood thinners.

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

Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Massed Prolonged Exposure therapy and either a stellate ganglion block or a sham injection

2 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at 1-, 3-, and 6-months posttreatment

Booster Sessions

Participants are offered three booster sessions to reinforce treatment

7 weeks

3 visits (in-person) at 1-, 3-, and 7-weeks posttreatment

Treatment Details

Interventions

• Ropivacaine injection

Trial Overview The study tests if adding a stellate ganglion block (a local anesthetic neck injection) to Massed Prolonged Exposure therapy improves PTSD outcomes compared to the same therapy with a sham injection.

Participant Groups

Group I: Stellate Ganglion Block Experimental Treatment 1 Intervention

One time administration of a stellate ganglion block

Group II: Sham SGB Placebo Group 1 Intervention

One time administration

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Stellate ganglion block (SGB) is a promising anesthetic treatment that has shown effectiveness in relieving symptoms of severe and chronic PTSD in some patients, despite current treatments often being ineffective or unacceptable.

The technique, which involves injecting a local anesthetic near a group of nerves in the neck, has been used since 1925 with very few side effects, but challenges remain due to a lack of randomized clinical trials and limited practitioner familiarity with its application for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the use of stellate ganglion block in the treatment of PTSD. Lipov, E., Ritchie, EC.[2018]

In a study of 205 patients with PTSD, 10 patients who did not respond to a right-sided stellate ganglion block (SGB) showed a remarkable 90% improvement in symptoms after receiving a left-sided SGB, with an average improvement of 28.3 points on the PTSD Checklist (PCL-5).

This suggests that left-sided SGB may be an effective alternative treatment for PTSD symptoms in patients who do not respond to right-sided SGB, highlighting the potential for tailored approaches in managing PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. Mulvaney, SW., Lynch, JH., Curtis, KE., et al.[2022]

Stellate ganglion blocks (SGBs) at the C6 level provided immediate and significant relief from PTSD symptoms in two soldiers, as evidenced by a substantial drop in their Post-traumatic Stress Disorder Checklist (PCL) scores after treatment.

Both patients were able to discontinue their antidepressant and antipsychotic medications while maintaining their improved mental health, suggesting that SGBs may offer a safe and effective alternative treatment for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Mulvaney, SW., McLean, B., de Leeuw, J.[2022]

In a study of 166 active duty service members with PTSD symptoms, over 70% experienced significant improvement in anxiety symptoms following stellate ganglion blocks (SGB), with effects lasting beyond 3 to 6 months.

The SGB procedure, performed at the C6 level, is considered safe and minimally invasive, offering a promising treatment option for managing PTSD-related anxiety in military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mulvaney, SW., Lynch, JH., Hickey, MJ., et al.[2018]

Stellate ganglion blocks (SGBs) were effective in reducing anxiety symptoms in four patients with combat-related PTSD, showing significant improvement in their Post-traumatic Stress Disorder Checklist (PCL) scores after treatment.

The SGB procedure, performed at the C6 level, is minimally invasive and has a strong safety profile, offering a potential alternative for patients who do not respond to traditional psychotropic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of stellate ganglion block in the treatment of anxiety symptoms from combat-related post-traumatic stress disorder: a case series. Alino, J., Kosatka, D., McLean, B., et al.[2017]

The stellate ganglion blockade (SGB) procedure for managing chronic post-traumatic stress disorder (PTSD) symptoms was performed safely on 250 patients over 18 months, with no immediate or delayed complications reported.

Patient feedback was overwhelmingly positive, with 100% satisfaction and willingness to recommend the procedure, indicating that SGB is well-tolerated and may provide significant therapeutic value for those with severe PTSD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. McLean, B.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

A review of the use of stellate ganglion block in the treatment of PTSD. [2018]

2. England pubmed.ncbi.nlm.nih.gov

The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy of stellate ganglion block in the treatment of anxiety symptoms from combat-related post-traumatic stress disorder: a case series. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. [2020]