Stellate Ganglion Block + Cognitive Processing Therapy for PTSD

(SGB Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Rush University Medical Center

Must not be taking: Blood thinners

Disqualifiers: Recent trauma, Suicidal, Psychosis, others

Trial Summary

What is the purpose of this trial?

This trial tests whether combining Cognitive Processing Therapy (CPT) with Stellate Ganglion Block (SGB) can better help people with PTSD. CPT is a talk therapy, and SGB is an injection that numbs nerves in the neck to reduce symptoms. Stellate Ganglion Block (SGB) has been investigated in trials for its potential to reduce PTSD symptoms, showing some promise in symptom reduction.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable dose of psychotropic medication for at least one month before starting and that you do not plan to change your medications within three months of starting the study. If you are on blood-thinning medications, you cannot participate.

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

Research shows that Stellate Ganglion Block (SGB) can help reduce PTSD symptoms, especially when combined with therapy. In one study, participants who received SGB along with therapy reported significant reductions in PTSD symptoms, with many no longer meeting the criteria for PTSD after treatment. ^{1 2 3 4 5}

Is Stellate Ganglion Block safe for treating PTSD?

Stellate Ganglion Block (SGB) has been used in several studies with military service members for PTSD, and the reported adverse events (unwanted side effects) are consistent with those seen in other treatments, suggesting it is generally safe. ^{1 2 3 4 5}

How is the treatment Stellate Ganglion Block + Cognitive Processing Therapy for PTSD different from other treatments?

This treatment is unique because it combines stellate ganglion block (SGB), an anesthetic injection near nerves in the neck, with cognitive processing therapy, a type of talk therapy. SGB is a novel approach for PTSD that targets the nervous system directly, which is different from traditional therapies that primarily focus on psychological aspects. ^{1 3 4 5 6}

Research Team

Eligibility Criteria

This trial is for adults over 18 in Illinois who have PTSD from a past traumatic event and can attend daily therapy for one week. They must speak English, have safe transport to the medical center, and not be on blood thinners or have certain health conditions like unmanaged psychosis, recent heart attack, or severe emphysema.

Inclusion Criteria

I have been diagnosed with PTSD by a professional using the CAPS-5.

You have been through a very upsetting event in your life.

I have never had a stellate ganglion block procedure.

Exclusion Criteria

You are currently planning or intending to harm yourself or someone else.

I currently have an active infection.

I have completed or am currently in a recognized PTSD therapy program.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a combined 1-week massed Cognitive Processing Therapy (CPT) and Stellate Ganglion Block (SGB) treatment or a 1-week massed CPT and placebo treatment

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Placebo (Procedure)
• Stellate Ganglion Block Treatment (Procedure)

Trial Overview The study tests if Cognitive Processing Therapy (CPT) for PTSD works better when combined with Stellate Ganglion Block (SGB), an injection that blocks pain signals. Participants will either receive CPT + SGB or CPT + placebo in a randomized controlled trial over one week.

Participant Groups

Group I: Stellate Ganglion Block Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Dr. Omar B. Lateef

Rush University Medical Center

Chief Executive Officer since 2022

MD from Des Moines University, Fellowship in Pulmonary and Critical Care Medicine at Rush University Medical Center

Dr. Paul E. Casey

Rush University Medical Center

Chief Medical Officer since 2021

MD, MBA

Findings from Research

This multisite, randomized clinical trial involving 113 active-duty service members demonstrated that two stellate ganglion block (SGB) treatments significantly reduced PTSD symptoms, with an average decrease of 12.6 points on the CAPS-5 scale compared to 6.1 points in the sham group.

The study suggests that SGB could be an effective adjunct treatment for PTSD, although the mild-moderate baseline severity of symptoms and short follow-up period may limit the broader applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. Rae Olmsted, KL., Bartoszek, M., Mulvaney, S., et al.[2021]

In a nonrandomized clinical trial with 12 participants, combining stellate ganglion blocks (SGB) with prolonged exposure therapy (PE) resulted in a significant reduction in PTSD symptoms, with a mean decrease of 32 points on the PTSD Checklist for DSM-5 (PCL-5).

90.9% of participants showed clinically significant improvement, and 50% no longer met the criteria for PTSD at a 1-month follow-up, suggesting that this combined treatment may enhance the effectiveness and tolerability of trauma-focused therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial. Peterson, AL., Straud, CL., Young-McCaughan, S., et al.[2022]

In a randomized trial involving military service members with PTSD, stellate ganglion block (SGB) did not show a significant difference in reducing PTSD symptoms compared to a sham procedure, indicating limited efficacy of SGB for this condition.

While some improvement in PTSD, anxiety, and depression scores was observed over time, the lack of a meaningful difference between the SGB and control groups suggests that SGB may not be a reliable treatment for PTSD, warranting further research into its potential effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Hanling, SR., Hickey, A., Lesnik, I., et al.[2019]

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 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

Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. [2021]

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

Combining a stellate ganglion block with prolonged exposure therapy for posttraumatic stress disorder: A nonrandomized clinical trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. [2019]

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. 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]

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

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