Effects of Stellate Ganglion Block on PTSD

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

This study is testing whether a special injection can help people with PTSD feel better and change how their brain works.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05391971 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of a stellate ganglion block on patients diagnosed with post-traumatic stress disorder (PTSD) according to DSM-5 criteria. Participants will be randomly assigned to receive either the treatment (bupivacaine) or a placebo (saline) after undergoing initial assessments, including functional MRI scans. The study aims to evaluate changes in PTSD symptoms and brain activity following the intervention, with assessments conducted at baseline and four weeks post-procedure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 with chronic PTSD symptoms lasting at least one month.

Not a fit: Patients with a history of stellate ganglion block treatment or significant psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals suffering from PTSD.

How similar studies have performed: While the approach is relatively novel, there have been some promising results in similar studies exploring nerve blocks for PTSD.

Eligibility criteria

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

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Paul Glimcher, PhD — NYU Langone Health
• Study coordinator: Paul Glimcher, PhD

Conditions Post Traumatic Stress Disorder