Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

NCT05391971 | Active Not Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 22-00374
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in Skin Conductance Response (SCR) Amount

  SCR will be reported as the number of sweat glads that are activated. The more emotionally aroused an individual is, the more the SCR amount is increased. SCR will be measured during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).

  Week 2, Week 8

• Change in Cerebral Blood Flow Levels

  Blood flow levels will be obtained from Blood Oxygen Level Dependent (BOLD) fMRI signals during three related viewing, learning, and choice tasks, quantified as the changes between the pre-intervention fMRI scan (visit 2) and the post-intervention fMRI scan (visit 5).

  Week 2, Week 8

Secondary Outcomes (12)

• Posttraumatic Stress Disorder Checklist (PCL-5) Score

  Week 1

• Posttraumatic Stress Disorder Checklist (PCL-5) Score

  Week 7

• Posttraumatic Stress Disorder Checklist (PCL-5) Score

  Week 15

• Patient Health Questionnaire-9 (PHQ-9) Score

  Week 1

• Patient Health Questionnaire-9 (PHQ-9) Score

  Week 7

Study Arms (2)

Stellate Ganglion Block (SGB) Group

EXPERIMENTAL

Drug: Bupivacaine

Control Group

PLACEBO COMPARATOR

Drug: Saline

Interventions

Bupivacaine 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.

Also known as: Marcaine

Stellate Ganglion Block (SGB) Group

Saline 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Paul Glimcher, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 26, 2022
• Study Start: August 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data upon reasonable request. Requests should be directed to paulg@nyu.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)