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Local Anesthetic
Stellate Ganglion Block for Post-Traumatic Stress Disorder
Phase 4
Recruiting
Led By Paul Glimcher, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-65 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, week 8
Awards & highlights
Study Summary
This trial will enroll people with PTSD and use fMRI to study brain function before and after they receive a treatment or placebo.
Who is the study for?
Adults aged 18-65 with chronic PTSD, as defined by DSM-5, and a CAPS-5 score of at least 26 can join. Participants must have been on stable medication for three months (excluding benzodiazepines) and be able to consent. Exclusions include allergies to certain anesthetics or contrast agents, severe mental health or substance use disorders, past stellate ganglion block treatment, pregnancy, neck surgeries, metal implants affecting MRI safety, current opioid/cocaine/benzodiazepine use, cancer diagnosis among others.Check my eligibility
What is being tested?
The trial is testing the effects of a stellate ganglion block injection in treating PTSD symptoms. Participants will receive either bupivacaine (anesthetic) or saline (placebo) injections under ultrasound guidance. The study includes initial screening and fMRI scans before and after the intervention to assess changes in brain function related to PTSD.See study design
What are the potential side effects?
Potential side effects from bupivacaine may include soreness at the injection site, trouble swallowing if it spreads beyond the target area; rare but serious complications could involve nerve damage or seizures if accidentally injected into blood vessels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cerebral Blood Flow Levels
Skin
Secondary outcome measures
Intolerance of Uncertainty Scale - Short Form (IUS-12) Score
Patient Health Questionnaire-9 (PHQ-9) Score
Posttraumatic Stress Disorder Checklist (PCL-5) Score
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stellate Ganglion Block (SGB) GroupExperimental Treatment1 Intervention
Group II: Control GroupPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,599 Total Patients Enrolled
Paul Glimcher, PhDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
397 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with bipolar I disorder and had a manic episode in the past year.I have had a stellate ganglion block procedure.I have COPD or asthma that hasn't been treated.I have issues with my vocal cords or paralysis.I am currently undergoing therapy for trauma.I have a history of brain-related diseases, seizures, or major head injuries.I am between 18 and 65 years old.I am currently diagnosed with cancer.I have had surgery on my neck or throat.I have been diagnosed with Parkinson's Disease.My BMI is over 40.My medications have been the same for the last 3 months, except for benzodiazepines.I have been diagnosed with Guillain-Barré syndrome.I have been diagnosed with a psychotic disorder or have had psychotic symptoms.I have had heavy metal poisoning in the past.I have high blood pressure that hasn't been treated.I have heart conditions or have had heart surgery.I have had PTSD symptoms for over a month.I am between 18 and 65 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Stellate Ganglion Block (SGB) Group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05391971 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration (FDA) sanctioned Bupivacaine for public use?
"Based on the Phase 4 categorization, Bupivacaine is accepted to be safe and thus received a rating of 3."
Answered by AI
Who is qualified to participate in this clinical trial?
"Participants must meet two criteria to be accepted into this clinical study. They should have PTSD and reside within the age range of 18-65 years old. As for numbers, 127 individuals are needed in total."
Answered by AI
What is the fundamental objective of this medical investigation?
"This clinical trial will be monitored over a period of two weeks and eight weeks, with the principal aim being to measure changes in cerebral blood flow levels. Secondary objectives include ascertaining participants' state-trait anxiety inventory (STAI) - Form Y1 scores; patient health questionnaire-9 (PHQ-9) scores; and intolerance of uncertainty scale - short form (IUS-12) scores."
Answered by AI
Is this medical study enrolling individuals aged 50 and above?
"This medical trial is open to those aged 18-65. There are 46 trials specifically targeting minors and 329 studies for seniors."
Answered by AI
Is there still capacity for enrollees in this clinical study?
"Affirmative. According to the clinicaltrials.gov database, this medical trial is currently recruiting patients. It was first advertised on June 27th 2022 and has since been updated for accuracy. The study requires 127 participants from a single site of recruitment."
Answered by AI
How many people have registered for the medical trial to date?
"Affirmative. According to information on clinicaltrials.gov, this research endeavour is currently recruiting participants; the trial was initially posted and last edited on 6/27/2022. The study aims to enlist 127 individuals from one site in total."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Oregon
Other
New York
How old are they?
18 - 65
What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
What questions have other patients asked about this trial?
Will you pay for travel to the study site?
PatientReceived 1 prior treatment
Why did patients apply to this trial?
I’ve had PTSD from rape since age 18. Having considerable challenges with my PTS after several years following my retirement from the Army.
PatientReceived 2+ prior treatments
I have tried therapy, medication, and none of it works. This is new to me so I’m really hoping that this could help. Tired of the anxiety, the helplessness/hopelessness that I feel.
PatientReceived 1 prior treatment
I've tried several medications and explored other avenues to treat my PTSD with no improvement. I also want to help others that suffer with PTSD by doing my part to contribute to finding a resolution.
PatientReceived no prior treatments
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