Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

NCT ID: NCT05391971

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2026-04-01

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Stellate Ganglion Block (SGB) Group

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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.

Control Group

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Marcaine

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Glimcher, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Paul Glimcher, PhD

Role: CONTACT

Paul.Glimcher@nyulangone.org

212-263-8169

Ana Varela

Role: CONTACT

ana.varela@nyulangone.org

Other Identifiers

22-00374

Identifier Type: -

Identifier Source: org_study_id