What side effects are associated with this type of intervention?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), which can cause side effects such as nausea, insomnia, sexual dysfunction, and weight gain. Stellate Ganglion Block, which involves injecting an anesthetic like bupivacaine into the cervical sympathetic tissue, is being studied for PTSD. Known side effects of this procedure can include temporary pain at the injection site, infection, bleeding, and in rare cases, nerve damage or complications related to the anesthetic used.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications work by altering neurotransmitter levels in the brain to help manage symptoms of PTSD. While the Stellate Ganglion Block with Bupivacaine involves an anesthetic action on cervical sympathetic tissue, there are no FDA-approved treatments for PTSD that use a similar mechanism. The current FDA-approved treatments do not include nerve blocks or anesthetic interventions targeting the sympathetic nervous system.

What other types of research exist?

Promising novel alternatives to Stellate Ganglion Block with Bupivacaine for PTSD treatment in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in reducing PTSD symptoms; 2) MDMA-assisted psychotherapy, which has demonstrated significant improvements in PTSD symptoms in clinical trials; and 3) Virtual Reality Exposure Therapy (VRET), which uses virtual reality to expose patients to trauma-related cues in a controlled environment, helping to reduce PTSD symptoms. These alternatives offer different mechanisms of action and may be suitable for patients seeking non-invasive or adjunctive treatment options.

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Local Anesthetic

Stellate Ganglion Block for Post-Traumatic Stress Disorder

Phase 4

Recruiting

Led By Paul Glimcher, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18-65 years

Be older than 18 years old

Must not have

Diagnosis of bipolar I disorder with a past year manic episode

History of stellate ganglion block treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, week 8

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing a treatment where a numbing medicine is injected into the neck to help patients with PTSD by blocking nerve signals. The goal is to see if this can reduce PTSD symptoms.

Who is the study for?

Adults aged 18-65 with chronic PTSD, as defined by DSM-5, and a CAPS-5 score of at least 26 can join. Participants must have been on stable medication for three months (excluding benzodiazepines) and be able to consent. Exclusions include allergies to certain anesthetics or contrast agents, severe mental health or substance use disorders, past stellate ganglion block treatment, pregnancy, neck surgeries, metal implants affecting MRI safety, current opioid/cocaine/benzodiazepine use, cancer diagnosis among others.

What is being tested?

The trial is testing the effects of a stellate ganglion block injection in treating PTSD symptoms. Participants will receive either bupivacaine (anesthetic) or saline (placebo) injections under ultrasound guidance. The study includes initial screening and fMRI scans before and after the intervention to assess changes in brain function related to PTSD.

What are the potential side effects?

Potential side effects from bupivacaine may include soreness at the injection site, trouble swallowing if it spreads beyond the target area; rare but serious complications could involve nerve damage or seizures if accidentally injected into blood vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with bipolar I disorder and had a manic episode in the past year.

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I have had a stellate ganglion block procedure.

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I have COPD or asthma that hasn't been treated.

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I have issues with my vocal cords or paralysis.

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I have a history of brain-related diseases, seizures, or major head injuries.

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I am currently diagnosed with cancer.

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I have had surgery on my neck or throat.

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I have been diagnosed with Parkinson's Disease.

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My BMI is over 40.

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I have been diagnosed with Guillain-Barré syndrome.

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I have been diagnosed with a psychotic disorder or have had psychotic symptoms.

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I have had heavy metal poisoning in the past.

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I have high blood pressure that hasn't been treated.

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I have heart conditions or have had heart surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Cerebral Blood Flow Levels

Skin

Secondary study objectives

Intolerance of Uncertainty Scale - Short Form (IUS-12) Score

Patient Health Questionnaire-9 (PHQ-9) Score

Posttraumatic Stress Disorder Checklist (PCL-5) Score

+1 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Stellate Ganglion Block (SGB) GroupExperimental Treatment1 Intervention

Group II: Control GroupPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacaine

2013

Completed Phase 4

~1530

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Stellate Ganglion Block (SGB) with Bupivacaine works by anesthetizing the cervical sympathetic tissue, which can modulate the autonomic nervous system and potentially reduce PTSD symptoms such as hyperarousal and anxiety. This treatment targets the sympathetic nervous system, which is often hyperactive in PTSD patients, leading to symptoms like heightened stress responses and sleep disturbances. By dampening this overactivity, SGB can help alleviate these symptoms, providing a targeted approach to managing PTSD. This is crucial for PTSD patients as it offers a potential reduction in symptoms that are otherwise difficult to manage with conventional therapies.