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

Inclusion Criteria6

18-65 years of age
Chronic (at least one month post-trauma) DSM-5 PTSD symptoms
CAPS-5 Past Month score ≥ 26
Meets current DSM-5 PTSD diagnosis
Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
Willing and able to provide informed consent

Exclusion Criteria24

History of stellate ganglion block treatment
Allergy to local anesthetics (e.g. ropivacaine, bupivacaine)
Allergy to iodinated contrast agents
Diagnosis of bipolar I disorder with a past year manic episode
Diagnosis of a psychotic disorder or psychotic symptoms
Diagnosis of current moderate or severe substance use disorder
History of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion)
Significant recent suicidal ideation or significant suicidal behavior in the past 12 months or suicidal ideation with imminent risk that warrants a higher level of care
Concurrent trauma focused psychotherapy
Pregnancy (to be ruled out by urine ß-HCG)
Metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fMRI data collection; cases will be cleared by the Principal Investigator and Center for Brain Imaging
Morbid obesity (BMI >4 kg/m2)
Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology)
Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.
Cardiac conditions or any prior heart surgeries
Respiratory conditions such as COPD or untreated asthma
History of heavy metal poisoning
History of neck or throat surgeries
Vocal cord problems or paralysis
Untreated high blood pressure
Current cancer diagnosis
Diagnosis of Guillain-Barré syndrome
Diagnosis of Parkinson's Disease
Unable to take 7 days off of blood thinners

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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.