Clinical trial NCT05391971: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Traumatic Stress Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Skin Conductance Response (SCR) Amount
timeFrame: Week 2, Week 8
measure: Change in Cerebral Blood Flow Levels
timeFrame: Week 2, Week 8
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist (PCL-5) Score
timeFrame: Week 1
measure: Posttraumatic Stress Disorder Checklist (PCL-5) Score
timeFrame: Week 7
measure: Posttraumatic Stress Disorder Checklist (PCL-5) Score
timeFrame: Week 15
measure: Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Week 1
measure: Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Week 7
measure: Patient Health Questionnaire-9 (PHQ-9) Score
timeFrame: Week 15
measure: State-Trait Anxiety Inventory (STAI) - Form Y1 Score
timeFrame: Week 1
measure: State-Trait Anxiety Inventory (STAI) - Form Y1 Score
timeFrame: Week 7
measure: State-Trait Anxiety Inventory (STAI) - Form Y1 Score
timeFrame: Week 15
measure: Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
timeFrame: Week 1
measure: Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
timeFrame: Week 7
measure: Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
timeFrame: Week 15
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Paul Glimcher, PhD
role: PRINCIPAL_INVESTIGATOR
References: