Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

Description

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.

Conditions

Post Traumatic Stress Disorder

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Study Overview

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Study Details

Study overview

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.

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

Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

Condition
Post Traumatic Stress Disorder
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Paul Glimcher, PhD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2025-08-15