RecruitingPhase 4NCT05391971

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

A Randomized, Double Blind, Placebo-controlled Study of the Effects of Stellate Ganglion Block on Neural Activity and Symptoms in Participants With Post-traumatic Stress Disorder

Sponsor

NYU Langone Health

Enrollment

80 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Post Traumatic Stress Disorder

Summary

This study will enroll patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for post-traumatic stress disorder (PTSD). Following an initial screening visit, clinical assessment, and enrollment, subjects will be randomized into treatment and placebo arms. Both cohorts will undergo a pre-intervention functional magnetic resonance imaging (fMRI) of their brain. Treatment subjects will receive unilateral two-level stellate ganglion block via ultrasound-guided injection of anesthetic (bupivacaine) into the cervical sympathetic tissue; placebo subjects will receive an identical volume of saline via the same procedures. At approximately 4 weeks post-procedure, both cohorts will then undergo a post-intervention clinical assessment. Finally, both cohorts will undergo a post-intervention fMRI of their brain.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a procedure called stellate ganglion block — where a local anesthetic is injected around a cluster of nerves in the neck — can reduce PTSD symptoms. The theory is that this nerve block may "reset" an overactivated stress response in the nervous system, providing relief from PTSD even in people who haven't fully responded to medications or therapy. **You may be eligible if...** - You are between 18 and 65 years old - You have been diagnosed with PTSD lasting at least one month after a traumatic event - Your PTSD symptoms are moderate to severe (CAPS-5 score of 26 or higher) - Your medications have been stable for at least 4 weeks **You may NOT be eligible if...** - You have previously had a stellate ganglion block - You are allergic to local anesthetics or contrast agents used during imaging - You have bipolar I disorder, active psychosis, or a history of schizophrenia - You are pregnant or have active bleeding disorders Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine

At the C6 level, a total of 7cc of 0.5% bupivacaine will be injected slowly at this level, with negative aspiration every 2cc. The same procedure will be repeated at the C4 level directed towards the upper cervical ganglion ventral to the longus colli muscle with a total of 3cc of 0.5% bupivacaine.

DRUGSaline

At the C6 level, a total of 7cc of saline control will be injected slowly at this level, with negative aspiration every 2cc. The same procedure will be repeated at the C4 level directed towards the upper cervical ganglion ventral to the longus colli muscle with a total of 3cc of saline control.

Locations(1)

NYU Langone Health

New York, New York, United States

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NCT05391971

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