Back to resultsEffects of Stellate Ganglion Block in Post-traumatic Stress Disorder
Primary Purpose
Post Traumatic Stress Disorder
Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Post Traumatic Stress Disorder
Eligibility Criteria
Inclusion Criteria:
- 18-65 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
Exclusion Criteria:
- 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
- Respiratory conditions such as COPD or untreated asthma
- History of heavy metal poisoning
- History of neck or throat surgeries
- Vocal cord problems or paralysis
- Untreated high blood pressure
- Current cancer diagnosis
- Diagnosis of Guillain-Barré syndrome
- Diagnosis of Parkinson's Disease
- Unable to take 7 days off of blood thinners
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Stellate Ganglion Block (SGB) Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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).
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).
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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).
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).
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).
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05391971
Brief Title
Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 27, 2022 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
127 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion Block (SGB) Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
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
Intervention Name(s)
Saline
Intervention Description
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 Measure Information:
Title
Change in Skin Conductance Response (SCR) Amount
Description
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).
Time Frame
Week 2, Week 8
Title
Change in Cerebral Blood Flow Levels
Description
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).
Time Frame
Week 2, Week 8
Secondary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Checklist (PCL-5) Score
Description
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.
Time Frame
Week 1
Title
Posttraumatic Stress Disorder Checklist (PCL-5) Score
Description
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.
Time Frame
Week 7
Title
Posttraumatic Stress Disorder Checklist (PCL-5) Score
Description
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.
Time Frame
Week 15
Title
Patient Health Questionnaire-9 (PHQ-9) Score
Description
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.
Time Frame
Week 1
Title
Patient Health Questionnaire-9 (PHQ-9) Score
Description
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.
Time Frame
Week 7
Title
Patient Health Questionnaire-9 (PHQ-9) Score
Description
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.
Time Frame
Week 15
Title
State-Trait Anxiety Inventory (STAI) - Form Y1 Score
Description
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).
Time Frame
Week 1
Title
State-Trait Anxiety Inventory (STAI) - Form Y1 Score
Description
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).
Time Frame
Week 7
Title
State-Trait Anxiety Inventory (STAI) - Form Y1 Score
Description
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).
Time Frame
Week 15
Title
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
Description
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.
Time Frame
Week 1
Title
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
Description
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.
Time Frame
Week 7
Title
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
Description
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.
Time Frame
Week 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-65 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
Exclusion Criteria:
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
Respiratory conditions such as COPD or untreated asthma
History of heavy metal poisoning
History of neck or throat surgeries
Vocal cord problems or paralysis
Untreated high blood pressure
Current cancer diagnosis
Diagnosis of Guillain-Barré syndrome
Diagnosis of Parkinson's Disease
Unable to take 7 days off of blood thinners
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Glimcher, PhD
Phone
212-263-8169
Email
Paul.Glimcher@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ryan Walters
Email
ryan.walters@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Glimcher, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Glimcher, PhD
First Name & Middle Initial & Last Name & Degree
Mohammed R Milad, PhD
First Name & Middle Initial & Last Name & Degree
Kenway Louie, MD PhD
First Name & Middle Initial & Last Name & Degree
Candace Raio, PhD
First Name & Middle Initial & Last Name & Degree
Lisa Doan, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
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