Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stellate Ganglion Block (SGB) Group<br> | Drug: Bupivacaine<br>* 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.<br>* Other names: Marcaine;|
| Placebo Comparator: Control Group<br> | Drug: Saline<br>* 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.<br>|

What is the study measuring?
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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 |