Stellate Ganglion Block for PTSD

Overseen By Rebecca Gomez, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Royal's Institute of Mental Health Research

Must not be taking: Anticoagulants

Disqualifiers: Bipolar, Psychotic disorder, Substance use, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how stellate ganglion block (SGB) can reduce PTSD symptoms, such as anxiety and heightened alertness. SGB involves injecting a local anesthetic (bupivacaine, also known as Marcaine or Sensorcaine) to temporarily calm nerves near the neck. Participants will be divided into two groups: one receiving a single dose and the other receiving two doses of the treatment. The trial seeks individuals with PTSD who have persistent symptoms despite trying other treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the validation of a potentially groundbreaking treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on anticoagulants unless they can be paused before the procedure.

What prior data suggests that this procedure is safe for treating PTSD?

Research shows that the stellate ganglion block (SGB) procedure, which uses bupivacaine, is generally well-tolerated. SGB involves injecting a numbing medicine around a group of nerves in the neck to help reduce PTSD symptoms. Studies have shown that this procedure has been safely used on veterans in the United States and for other medical conditions in Canada.

These studies report no significant negative effects on thinking or memory. While the procedure can cause numbness or temporary changes in sensation, these effects do not last. Overall, evidence suggests that SGB is a safe option for treating PTSD symptoms, though more research is needed to confirm its safety in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for PTSD?

Researchers are excited about the Stellate Ganglion Block (SGB) for PTSD because it offers a unique approach by using bupivacaine to target the stellate ganglion, a collection of nerves in the neck associated with the body's stress response. Unlike standard treatments for PTSD, which often involve long-term medication like SSRIs or cognitive behavioral therapy, SGB can provide rapid relief from symptoms. The trial explores two variations: a single dose and repeated doses of bupivacaine, potentially offering flexibility in treatment duration and intensity. This innovative method could revolutionize PTSD management by offering faster and potentially longer-lasting relief without the need for daily medication.

What evidence suggests that the stellate ganglion block is effective for PTSD?

Research has shown that a treatment called stellate ganglion block (SGB) can significantly reduce PTSD symptoms. Some studies, including those involving military veterans, found that SGB quickly eases anxiety, irritability, and hyper-alertness. The treatment uses a local anesthetic, bupivacaine, to temporarily block nerve signals in the neck. Although the effect lasts only a few hours, many patients report a lasting decrease in PTSD symptoms. In this trial, participants will join one of two groups: one receiving a single SGB with a 5 mL dose of 0.5% preservative-free bupivacaine, and the other receiving repeated SGB with two such doses. The procedure is considered safe and has been used for other conditions, supporting its potential effectiveness for PTSD. Further studies are underway to confirm these promising results. ^{1 2 3 6 7}

Who Is on the Research Team?

Rebecca Gomez, MD

Principal Investigator

Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre

Are You a Good Fit for This Trial?

This trial is for individuals with PTSD who haven't improved after standard treatments or prefer trying the Stellate Ganglion Block (SGB) procedure. Participants must have a formal PTSD diagnosis and experience significant hyperarousal symptoms, and be under a mental health clinician's care.

Inclusion Criteria

I have been diagnosed with PTSD, with significant symptoms of being easily startled or tense.

I haven't improved with standard treatments and agree to try a new procedure.

Under care of a mental health clinician

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single or repeated Stellate Ganglion Block (SGB) procedure with 0.5% preservative-free bupivacaine

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in PTSD symptoms, anxiety, depression, and overall functioning

12 weeks

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine

Trial Overview The trial tests SGB, where an anesthetic called bupivacaine is injected near neck nerves to potentially reduce PTSD symptoms like anxiety and irritability. It aims to evaluate SGB's effectiveness in Canada, where it isn't yet approved for general PTSD treatment.

How Is the Trial Designed?

Group I: Single SGB Experimental Treatment 1 Intervention

This arm will receive a single 5 mL dose of 0.5% preservative-free bupivacaine.

Group II: Repeated SGB Experimental Treatment 1 Intervention

This arm will receive two 5 mL doses of 0.5% preservative-free bupivacaine.

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

The Royal's Institute of Mental Health Research

Lead Sponsor

Trials

8

Recruited

1,300+

Ottawa Hospital Research Institute

Collaborator

Trials

585

Recruited

3,283,000+

Citations

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

Evidence Brief: Effectiveness of Stellate Ganglion Block for ... A proposed explanation for the prolonged effectiveness of SGB on PTSD, as well as symptoms of hot flashes and complex regional pain syndrome, is that ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05391971?term=Stellate+ganglion+block&cond=Ptsd&draw=2

Effects of Stellate Ganglion Block in Post-traumatic Stress ... This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress ...

3. 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 ...

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/esp/ganglionblock-supplemental.pdf

Evidence Brief: Effectiveness of Stellate Ganglion Block for ... The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) ... making is that loss of PTSD diagnosis is a desired outcome.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11613001/

Optimizing clinical outcomes with stellate ganglion block ... Across the full range of existing case reports and studies, the efficacy of SGB for symptoms of trauma ranges from 70–83% of treated patients seeing clinically ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/540815

Effects of Stellate Ganglion Block in Post-traumatic Stress ... This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ...