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
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Change in Skin Conductance Response (SCR) Amount
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Control Group
Intervention: Saline (Drug)
Stellate Ganglion Block (SGB) Group
Intervention: Bupivacaine (Drug)
Outcomes
Primary Outcomes
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).
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 Outcomes
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 15)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 15)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 15)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 15)
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 1)
- Posttraumatic Stress Disorder Checklist (PCL-5) Score(Week 7)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 1)
- Patient Health Questionnaire-9 (PHQ-9) Score(Week 7)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 1)
- State-Trait Anxiety Inventory (STAI) - Form Y1 Score(Week 7)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 1)
- Intolerance of Uncertainty Scale - Short Form (IUS-12) Score(Week 7)