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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

Summary

This trial will enroll people with PTSD and use fMRI to study brain function before and after they receive a treatment or placebo.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cerebral Blood Flow Levels
Skin
Secondary outcome measures
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

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

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.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,379 Previous Clinical Trials
847,991 Total Patients Enrolled
Paul Glimcher, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
397 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05391971 — Phase 4
Post-Traumatic Stress Disorder Research Study Groups: Control Group, Stellate Ganglion Block (SGB) Group
Post-Traumatic Stress Disorder Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05391971 — Phase 4
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05391971 — Phase 4
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05391971 — Phase 4
~37 spots leftby Jun 2025