Stellate Ganglion Block for PTSD

(SGB-PTSD Trial)

Recruiting at 5 trial locations

Overseen By Anastasia Krajec, RN

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

360 Participants Needed

Trial Summary

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

Research shows that stellate ganglion block (SGB), which involves an injection in the neck to calm the body's stress response, has been successfully used to reduce PTSD symptoms in several studies, including cases with combat-related anxiety. ^{1 2 3 4 5}

Is Stellate Ganglion Block safe for humans?

Research shows that Stellate Ganglion Block (SGB) is generally safe for treating symptoms of post-traumatic stress disorder (PTSD), with multiple studies reporting its safety and patient acceptability. ^{1 2 3 5 6}

How is the stellate ganglion block treatment different from other PTSD treatments?

Stellate ganglion block (SGB) is unique because it involves an injection of a local anesthetic in the neck to block nerves that control the body's fight-or-flight response, providing immediate relief from PTSD symptoms. Unlike many standard PTSD treatments, SGB is a quick outpatient procedure with few side effects and has shown promise in patients who do not respond to other therapies. ^{1 2 3 4 7}

What is the purpose of this trial?

This trial tests if an injection near neck nerves can help Veterans with chronic PTSD who need alternative treatments. The injection may calm overactive nerves, reducing PTSD symptoms quickly. This method has been explored for treating various conditions, including PTSD, with mixed evidence.

Research Team

Michael Hollifield, MD

Principal Investigator

VA Long Beach Healthcare System, Long Beach, CA

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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]

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]

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]

References

1. 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]

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. 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]

4. 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]

5. 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]

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

Clinical Guidelines for Stellate Ganglion Block to Treat Anxiety Associated With Posttraumatic Stress Disorder. [2022]

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

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