Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder
- Registration Number
- NCT05391971
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 127
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Saline - Stellate Ganglion Block (SGB) Group Bupivacaine -
- Primary Outcome Measures
Name Time Method Change in Skin Conductance Response (SCR) Amount 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).
Change in Cerebral Blood Flow Levels 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
Name Time Method Posttraumatic Stress Disorder Checklist (PCL-5) Score 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.
Patient Health Questionnaire-9 (PHQ-9) Score 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.
State-Trait Anxiety Inventory (STAI) - Form Y1 Score 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).
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score 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.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States