Stellate Ganglion Block (SGB) Group for Post Traumatic Stress Disorder (PTSD)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
NYU Langone Health, New York, NY
Post Traumatic Stress Disorder (PTSD)+2 More
Bupivacaine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Post Traumatic Stress Disorder (PTSD)

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Post Traumatic Stress Disorder (PTSD)

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Week 2, Week 8

Week 15
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
Patient Health Questionnaire-9 (PHQ-9) Score
Posttraumatic Stress Disorder Checklist (PCL-5) Score
State-Trait Anxiety Inventory (STAI) - Form Y1 Score
Week 2, Week 8
Change in Cerebral Blood Flow Levels
Change in Skin Conductance Response (SCR) Amount

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Post Traumatic Stress Disorder (PTSD)

Trial Design

2 Treatment Groups

Stellate Ganglion Block (SGB) Group
1 of 2
Control Group
1 of 2
Experimental Treatment
Non-Treatment Group

127 Total Participants · 2 Treatment Groups

Primary Treatment: Stellate Ganglion Block (SGB) Group · Has Placebo Group · Phase 4

Stellate Ganglion Block (SGB) Group
Drug
Experimental Group · 1 Intervention: Bupivacaine · Intervention Types: Drug
Control Group
Drug
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 2, week 8
Closest Location: NYU Langone Health · New York, NY
Photo of NYU Langone Health  1Photo of NYU Langone Health  2Photo of NYU Langone Health  3
2020First Recorded Clinical Trial
4 TrialsResearching Post Traumatic Stress Disorder (PTSD)
107 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are between the ages of 18 and 65.
You have persistent symptoms of post-traumatic stress disorder (PTSD) for at least one month post-trauma.
You have a CAPS-5 score of 26 or higher.
You have been taking the same medications for at least 3 months prior to study entry.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.