Status:
RECRUITING
Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
Lead Sponsor:
NYU Langone Health
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05391971
Start Date
August 1 2022
End Date
April 1 2026
Last Update
January 6 2026
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016