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ACTIVE NOT RECRUITING

NCT05391971

PHASE4

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-08-01

Completion Date

2026-06-30

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Post Traumatic Stress Disorder

Interventions

DRUG

Bupivacaine

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.

DRUG

Saline

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.

Inclusion Criteria: 1. 18-65 years of age 2. Chronic (at least one month post-trauma) DSM-5 PTSD symptoms 3. CAPS-5 Past Month score ≥ 26 4. Meets current DSM-5 PTSD diagnosis 5. Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines) 6. Willing and able to provide informed consent Exclusion Criteria: 1. History of stellate ganglion block treatment 2. Allergy to local anesthetics (e.g. ropivacaine, bupivacaine) 3. Allergy to iodinated contrast agents 4. Diagnosis of bipolar I disorder with a past year manic episode 5. Diagnosis of a psychotic disorder or psychotic symptoms 6. Diagnosis of current moderate or severe substance use disorder 7. 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) 8. 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 9. Concurrent trauma focused psychotherapy 10. Pregnancy (to be ruled out by urine ß-HCG) 11. 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 12. Morbid obesity (BMI \>4 kg/m2) 13. Current use of opioids, cocaine, or benzodiazepines (as assessed by urine toxicology) 14. Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily. 15. Cardiac conditions or any prior heart surgeries 16. Respiratory conditions such as COPD or untreated asthma 17. History of heavy metal poisoning 18. History of neck or throat surgeries 19. Vocal cord problems or paralysis 20. Untreated high blood pressure 21. Current cancer diagnosis 22. Diagnosis of Guillain-Barré syndrome 23. Diagnosis of Parkinson's Disease 24. Unable to take 7 days off of blood thinners

Locations (1)

NYU Langone Health

New York, New York, United States