Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

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 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.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Bupivacaine; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 127
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Paul Glimcher, PhD; Phone Number: 212-263-8169; Email: Paul.Glimcher@nyulangone.org
• Study Contact Backup: Name: Ryan Walters; Email: ryan.walters@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Principal Investigator: Paul Glimcher, PhD
      • Sub-Investigator: Mohammed R Milad, PhD
      • Sub-Investigator: Kenway Louie, MD PhD
      • Sub-Investigator: Candace Raio, PhD
      • Sub-Investigator: Lisa Doan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	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.
Experimental: Stellate Ganglion Block (SGB) Group	Drug: 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.; Other Names: Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posttraumatic Stress Disorder Checklist (PCL-5) Score	The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.	Week 1
Posttraumatic Stress Disorder Checklist (PCL-5) Score	The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.	Week 7
Posttraumatic Stress Disorder Checklist (PCL-5) Score	The PCL-5 is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorders (DSM-5) symptoms of post-traumatic stress disorder (PTSD). The self-report rating scale is 0-4 for each symptom. Rating scale descriptors are the same: "Not at all," "A little bit," Moderately," "Quite a bit," and "Extremely." A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items; the higher the score, the more severe the PTSD symptoms.	Week 15
Patient Health Questionnaire-9 (PHQ-9) Score	PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.	Week 1
Patient Health Questionnaire-9 (PHQ-9) Score	PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.	Week 7
Patient Health Questionnaire-9 (PHQ-9) Score	PHQ-9 consists of 9 items. Participants report how often they have been bothered by each item over the last 2 weeks with a score 0 (not at all) to 3 (nearly every day). The total score range is 0-27; the higher the score, the more severe the depression.	Week 15
State-Trait Anxiety Inventory (STAI) - Form Y1 Score	STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).	Week 1
State-Trait Anxiety Inventory (STAI) - Form Y1 Score	STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).	Week 7
State-Trait Anxiety Inventory (STAI) - Form Y1 Score	STAI - Form Y1 is a commonly used measure of trait and state anxiety that consists of 20 statement which people have used to describe themselves. Each statement is scored from 1 (Not at all) to 4 (very much so). The total score range is 20-80; STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).	Week 15
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score	IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.	Week 1
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score	IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.	Week 7
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score	IUS-12 is a 12-item self-report questionnaire where items are rated on 5-point Likert scales. IUS-12 is based on a definition of general uncertainty-related reactions that may be present in different anxiety disorders. Each item is scored from 1 (not at all characteristic of me) to 5 (entirely characteristic of me). The total score range is 12-60; the higher the score, the greater the intolerance of uncertainty.	Week 15

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Paul Glimcher, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): June 10, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 23, 2022
• First Posted (Actual): May 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 22-00374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes