Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391971
• Other study ID #: 22-00374
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2022
• Est. completion date: August 15, 2025

Study information

• Verified date: April 2024
• Source: NYU Langone Health
• Contact: Paul Glimcher, PhD
• Phone: 212-263-8169
• Email: Paul.Glimcher[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 127
• Est. completion date: August 15, 2025
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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