Stellate Ganglion Block + Cognitive Processing Therapy for PTSD

(SGB Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Must not be taking: Blood thinners

Disqualifiers: Recent trauma, Suicidal, Psychosis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new PTSD treatment by combining Cognitive Processing Therapy (CPT) and Stellate Ganglion Block (SGB). CPT is a well-known therapy for PTSD, but many patients still experience symptoms after treatment. SGB involves a local anesthetic injection near the base of the neck to reduce stress signals. The study aims to determine if adding SGB to CPT improves outcomes. The trial seeks participants with PTSD who live in Illinois and are willing to engage in a week of daily therapy. As an unphased trial, it offers a unique opportunity to contribute to innovative PTSD treatment research.

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 prior data suggests that the Stellate Ganglion Block is safe for PTSD treatment?

A previous study showed that the Stellate Ganglion Block (SGB) treatment for PTSD is safe and well-tolerated. This treatment involves an injection of numbing medicine at the base of the neck. Research indicates that this procedure is acceptable to patients and does not affect brain function. Studies have found that many patients experience quick improvement in their PTSD symptoms after receiving SGB. While no major safety concerns have been reported, discussing any concerns with a healthcare provider before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stellate Ganglion Block (SGB) for PTSD because it offers a unique approach compared to traditional treatments like psychotherapy and medication. Unlike standard care options that primarily focus on altering brain chemistry or behavior over time, SGB targets the stellate ganglion, a group of nerves in the neck, to quickly reduce symptoms by interrupting the body's stress response. This method has the potential to deliver rapid relief, making it particularly appealing for individuals who need immediate symptom management. Additionally, when combined with Cognitive Processing Therapy, SGB could enhance the effectiveness of therapy by creating an optimal state for processing traumatic memories.

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

Studies have shown that Stellate Ganglion Block (SGB), a treatment tested in this trial, can help reduce PTSD symptoms. One study found that patients who received two SGB treatments experienced a significant drop in their PTSD symptoms. Another review indicated that SGB quickly improved symptoms for 70% to 75% of patients. This trial will compare SGB to a placebo treatment to determine its effectiveness. Researchers are also investigating whether combining SGB with Cognitive Processing Therapy (CPT), which already benefits many people with PTSD, could enhance treatment outcomes. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Stellate Ganglion Block Treatment

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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]

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. 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 ...

4. 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 ...

5. 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 ...

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

Stellate ganglion blockade for the treatment of post ... Neurocognitive performance is not degraded after stellate ganglion block treatment for post-traumatic stress disorder: a case series. Mil. Med. 2015; 180 ...

8. 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).