Stellate Ganglion Block for PTSD

(SGB-PTSD Trial)

Not currently recruiting at 5 trial locations

Overseen By Jaime Martin, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Centrally acting medications, Opiates

Disqualifiers: Psychosis, Substance dependence, Thyroid disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether Stellate Ganglion Block (SGB) can reduce symptoms of Posttraumatic Stress Disorder (PTSD) in Veterans. SGB involves an injection that early studies have shown to quickly ease PTSD symptoms, though further research is needed to confirm its effectiveness and safety. The trial will compare the effects of SGB treatment against a placebo and a wait-list group to determine its true efficacy and the duration of its benefits. Veterans diagnosed with PTSD, who have tried at least one prior treatment and still experience significant symptoms, might be suitable candidates for this study. As an unphased trial, this study offers Veterans the chance to contribute to groundbreaking research that could lead to new PTSD treatments.

Do I need to stop my current medications for the trial?

Participants must continue their current medications at the same doses for the duration of the trial. If you are on a stable medication dose for more than 8 weeks, you can continue these medications during the trial.

What prior data suggests that Stellate Ganglion Block is safe for treating PTSD?

A previous study found the Stellate Ganglion Block (SGB) treatment to be safe and well-tolerated for managing severe symptoms in people with PTSD. This treatment is already used for pain and other conditions. So far, small studies suggest it may quickly reduce PTSD symptoms.

While these smaller studies show promising safety results, larger studies have not yet clarified the effects. However, most people who try the procedure find it acceptable and manageable.

Overall, SGB has a strong safety record for other uses, and early research for PTSD is encouraging. However, more information from larger studies is needed to fully understand its safety for PTSD treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stellate Ganglion Block (SGB) is unique because it targets the sympathetic nervous system by injecting an anesthetic near a cluster of nerves in the neck. Unlike traditional PTSD treatments like psychotherapy or medications such as SSRIs and SNRIs, which can take weeks to months to show effectiveness, SGB has the potential to provide rapid symptom relief. Researchers are excited about this treatment because it offers a novel approach by directly addressing the physiological stress response, which could lead to quicker, more targeted relief for PTSD sufferers.

What evidence suggests that Stellate Ganglion Block might be an effective treatment for PTSD?

Research has shown that Stellate Ganglion Block (SGB), which participants in this trial may receive, can help reduce PTSD symptoms. One study found that PTSD symptoms improved by 5.4% to 14.7% after one SGB treatment and by 12.1% to 21.2% after a second treatment. Another study found that two SGB treatments, given two weeks apart, significantly reduced PTSD severity scores. While early results are promising, larger studies have produced mixed results, indicating that more research is needed to confirm its effectiveness. ^{3 4 5 6 7}

Who Is on the Research Team?

Michael Hollifield, MD

Principal Investigator

VA Long Beach Healthcare System, Long Beach, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with chronic PTSD who have tried at least one evidence-based treatment without sufficient relief. They must meet specific criteria for moderate PTSD severity, be willing to suspend current active psychotherapy if selected, and not have certain conditions like severe depression or substance dependence.

Inclusion Criteria

At least moderate PTSD with a total CAPS-5 score of > 26

I have been diagnosed with chronic PTSD.

At least moderate PTSD with a total CAPS-5 score of > 26

Exclusion Criteria

I have been exposed to chemicals or trauma that affected my brain or mental health.

High risk of acute suicidality

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Stellate Ganglion Block (SGB) or control interventions (Sham or Wait-List Control) to assess short-term efficacy and safety

12 weeks

Multiple visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of PTSD symptom severity and biological effects

8 weeks

Open-label extension

Participants are offered active SGB if eligible, allowing evaluation of enhanced dosing and long-term effects

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sham Stellate Ganglion Block
• Stellate Ganglion Block

Trial Overview The study tests the Stellate Ganglion Block (SGB), a procedure used for pain management that may reduce PTSD symptoms quickly. Participants will either receive SGB or a sham procedure to compare effectiveness, durability of effects, safety, and biological mechanisms behind SGB's potential benefits.

How Is the Trial Designed?

Group I: SGB Active Control 1 Intervention

SGB, the experimental procedure, is the injection of 7 cc of 0.5% ropivacaine plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

Group II: Wait-List Control (WLC) Active Control 1 Intervention

WLC, a control for time, expectancy and safety, is all study procedures without going to the procedure room for injection

Group III: Sham Placebo Group 1 Intervention

Sham, the placebo control group, is the injection of 7 cc of normal saline plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle

Stellate Ganglion Block is already approved in United States for the following indications:

Approved in United States as Stellate Ganglion Block for:

• Chronic pain management
• Posttraumatic stress disorder (PTSD) symptoms reduction

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Analydata, Inc

Collaborator

Trials

2

Recruited

450+

Analydata, Inc.

Industry Sponsor

Trials

2

Recruited

450+

Published Research Related to This Trial

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 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]

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 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]

Right-sided stellate ganglion block (SGB) has shown safety and efficacy in treating anxiety symptoms related to posttraumatic stress disorder (PTSD), based on multiple case series in medical literature.

Clinical guidelines have been developed to help healthcare providers with patient selection and education for SGB, along with a technique for performing the procedure under ultrasound guidance, although more rigorous research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Guidelines for Stellate Ganglion Block to Treat Anxiety Associated With Posttraumatic Stress Disorder. Mulvaney, SW., Lynch, JH., Kotwal, RS.[2022]

Citations

1. 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03077919

Effectiveness and Acceptability of Stellate Ganglion Block ... This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute ...

3. hsrd.research.va.gov hsrd.research.va.gov/publications/management_briefs/default.cfm?ManagementBriefsMenu=eBrief-no124&eBriefTitle=Effectiveness+of+Stellate+Ganglion+Block+for+Treatment+of+PTSD

Effectiveness of Stellate Ganglion Block for Treatment of PTSD In the aforementioned case series, SGB for PTSD had high rates of rapid clinical improvement in PTSD symptoms (70% to 75%). However, findings from the first RCT ...

4. 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 ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1566070225001225

Review Article Stellate ganglion blockade for the treatment ... There's some evidence that SGB can help alleviate PTSD symptoms. •. SGB may show beneficial results in situations with co-morbidities linked ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4601906/

Safety and Patient Acceptability of Stellate Ganglion ... The SGB procedure for PTSD is a safe, well-tolerated, and acceptable treatment adjunct in the management of severe symptoms associated with chronic treatment- ...

7. reporter.nih.gov reporter.nih.gov/project-details/10909798

Project Details - NIH RePORTER Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly ...