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Stellate Ganglion Block + Cognitive Processing Therapy for PTSD (SGB Trial)
N/A
Recruiting
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5
Have not previously received stellate ganglion blocks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, on average of 3 months
Awards & highlights
SGB Trial Summary
This trial is examining whether combining Cognitive Processing Therapy with a Stellate Ganglion Block, which involves a local anesthesia injection to the neck, is more effective in reducing PTSD symptoms than CPT alone.
Who is the study for?
This trial is for adults over 18 in Illinois who have PTSD from a past traumatic event and can attend daily therapy for one week. They must speak English, have safe transport to the medical center, and not be on blood thinners or have certain health conditions like unmanaged psychosis, recent heart attack, or severe emphysema.Check my eligibility
What is being tested?
The study tests if Cognitive Processing Therapy (CPT) for PTSD works better when combined with Stellate Ganglion Block (SGB), an injection that blocks pain signals. Participants will either receive CPT + SGB or CPT + placebo in a randomized controlled trial over one week.See study design
What are the potential side effects?
Possible side effects of the Stellate Ganglion Block treatment include soreness at the injection site, light-headedness, temporary voice changes due to local anesthesia effects on vocal cords, and rare complications related to needle placement.
SGB Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with PTSD by a professional using the CAPS-5.
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I have never had a stellate ganglion block procedure.
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I am willing and able to attend daily therapy sessions for one week.
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I am 18 years old or older.
SGB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, on average of 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, on average of 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician Administered PTSD Scale for DSM-5
PTSD Checklist for DSM-5 Criteria
SGB Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Stellate Ganglion BlockActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
424 Previous Clinical Trials
156,603 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with PTSD by a professional using the CAPS-5.You are currently planning or intending to harm yourself or someone else.You have been through a very upsetting event in your life.I currently have an active infection.I have completed or am currently in a recognized PTSD therapy program.I am allergic to certain medications like ropivacaine, lidocaine, or propofol.I do not have any hearing or vision problems that would stop me from joining in the study activities.I am taking blood-thinning medication or have a bleeding disorder.I have never had a stellate ganglion block procedure.I have not had a recent heart attack, glaucoma, nerve palsy, severe emphysema, or heart rhythm problems.You have a significant problem with thinking or understanding that would make it hard for you to participate in the study activities.I haven't changed my mental health medication dose for a month.I experienced a traumatic event within the last month.I have a serious health condition that might require hospitalization soon.I am willing and able to attend daily therapy sessions for one week.You have untreated severe mental illness.I am 18 years old or older.You are currently involved in a legal case related to the traumatic event that the treatment is supposed to help with.
Research Study Groups:
This trial has the following groups:- Group 1: Stellate Ganglion Block
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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.
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