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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Paul Glimcher, PhD
Paul.Glimcher@nyulangone.org
212-263-8169
Backup
Ana Varela
ana.varela@nyulangone.org
Time Frame
Start Date: 2022-08-01
Estimated Completion Date: 2025-08-15
Participants
Target number of participants: 90
Treatments
Experimental: Stellate Ganglion Block (SGB) Group
Placebo_comparator: Control Group
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov