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Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT05391971
Recruitment Status : Recruiting
First Posted : May 26, 2022
Last Update Posted : June 30, 2022
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Drug: Bupivacaine Drug: Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : June 15, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: Marcaine

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.




Primary Outcome Measures :
  1. Change in Skin Conductance Response (SCR) Amount [ Time Frame: Week 2, Week 8 ]
    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).

  2. Change in Cerebral Blood Flow Levels [ Time Frame: Week 2, Week 8 ]
    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).


Secondary Outcome Measures :
  1. Posttraumatic Stress Disorder Checklist (PCL-5) Score [ Time Frame: Week 1 ]
    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.

  2. Posttraumatic Stress Disorder Checklist (PCL-5) Score [ Time Frame: Week 7 ]
    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.

  3. Posttraumatic Stress Disorder Checklist (PCL-5) Score [ Time Frame: Week 15 ]
    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.

  4. Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Week 1 ]
    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.

  5. Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Week 7 ]
    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.

  6. Patient Health Questionnaire-9 (PHQ-9) Score [ Time Frame: Week 15 ]
    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.

  7. State-Trait Anxiety Inventory (STAI) - Form Y1 Score [ Time Frame: Week 1 ]
    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).

  8. State-Trait Anxiety Inventory (STAI) - Form Y1 Score [ Time Frame: Week 7 ]
    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).

  9. State-Trait Anxiety Inventory (STAI) - Form Y1 Score [ Time Frame: Week 15 ]
    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).

  10. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score [ Time Frame: Week 1 ]
    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.

  11. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score [ Time Frame: Week 7 ]
    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.

  12. Intolerance of Uncertainty Scale - Short Form (IUS-12) Score [ Time Frame: Week 15 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05391971


Contacts
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Contact: Paul Glimcher, PhD 212-263-8169 Paul.Glimcher@nyulangone.org
Contact: Ryan Walters rdw304@nyu.edu

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
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         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Paul Glimcher, PhD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT05391971    
Other Study ID Numbers: 22-00374
First Posted: May 26, 2022    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

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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
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents