Stellate Ganglion Block + Therapy for PTSD

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a nerve-blocking injection called a stellate ganglion block (SGB) can enhance treatment for PTSD when combined with Massed Prolonged Exposure therapy, a type of talk therapy. Researchers aim to determine if this combination is more effective than therapy with a placebo injection. The trial also seeks to understand how certain physical responses during therapy may influence treatment success. Military service members or retirees with PTSD who can receive care at a military facility might be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the stellate ganglion block (SGB) using ropivacaine, a type of numbing medicine, is generally safe for treating PTSD. Studies have found that SGB can help reduce PTSD symptoms without affecting cognitive abilities. No major safety concerns have been reported. Any side effects are usually mild and may include temporary discomfort at the injection site. This suggests that SGB is well-tolerated by people with PTSD. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Researchers are excited about using Stellate Ganglion Block (SGB) for PTSD because it offers a novel approach compared to traditional treatments like psychotherapy and medications such as SSRIs and SNRIs. Unlike these standard therapies that target brain chemistry over extended periods, SGB involves a one-time injection of ropivacaine into a nerve cluster in the neck, potentially providing rapid relief from PTSD symptoms. This method directly influences the nervous system to reduce the "fight or flight" response, which is often heightened in PTSD. Additionally, the use of ropivacaine, an anesthetic, could make this treatment minimally invasive with fewer systemic side effects.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that a stellate ganglion block (SGB), a type of injection, can help reduce PTSD symptoms. In some studies, one SGB treatment improved PTSD symptoms by 5.4% to 14.7%. When participants received two treatments, improvements ranged from 12.1% to 21.2%. Other research found that two SGB treatments reduced PTSD symptoms over eight weeks. In this trial, participants will receive either a real SGB injection or a sham SGB as a placebo comparator. Previous studies suggest that SGB injections lead to significantly better improvements in PTSD symptoms compared to sham treatments, indicating that SGB could be a helpful addition to PTSD therapies like Massed Prolonged Exposure. ^{1 2 3 4 6}

Who Is on the Research Team?

Alan Peterson, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK442253/

Evidence Brief: Effectiveness of Stellate Ganglion Block for ... In the RCT, the range of mean percent PTSD improvement after one round of SGB was 5.4% to 14.7%, and was 12.1% to 21.2% after the second round, which was no ...

2. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2753810

Effect of Stellate Ganglion Block Treatment on ... 2 stellate ganglion block treatments 2 weeks apart were effective in reducing Clinician-Administered PTSD Scale for DSM-5 total symptom severity scores over 8 ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK571916/

Stellate Ganglion Block for the Treatment of Post-Traumatic ... In the identified primary study, SGB injections resulted in significantly greater improvements in PCL-5 and PCL-C-IV scores at 8 weeks compared to the sham ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05107752

Stellate Ganglion Block to Augment Trauma-focused ... Our long-term goal is to improve clinical outcomes among patients receiving psychological treatment for posttraumatic stress disorder (PTSD).

5. autonomicneuroscience.com autonomicneuroscience.com/article/S1566-0702(25)00122-5/fulltext

Stellate ganglion blockade for the treatment of post ... There's some evidence that SGB can help alleviate PTSD symptoms. •. SGB may show beneficial results in situations with co-morbidities linked to PTSD, such as ...

6. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1663506/full

Effect of stellate ganglion block on the prevention ... Stellate ganglion block (SGB) has been shown to alleviate PTSD symptoms, suggesting its potential as a preventive intervention, particularly in ...