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Stellate Ganglion Block for PTSD (SGB-PTSD Trial)
N/A
Recruiting
Led By Michael Hollifield, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM-5 criteria for chronic PTSD on the Clinician Administered PTSD Scale (CAPS-5)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after sgb, sham, or wlc enrollment
Awards & highlights
SGB-PTSD Trial Summary
This trial will assess whether or not Stellate Ganglion Block (SGB), a treatment established to relieve pain, can also help reduce the symptoms of Posttraumatic Stress Disorder (PTSD).
Who is the study for?
This trial is for Veterans with chronic PTSD who have tried at least one evidence-based treatment without sufficient relief. They must meet specific criteria for moderate PTSD severity, be willing to suspend current active psychotherapy if selected, and not have certain conditions like severe depression or substance dependence.Check my eligibility
What is being tested?
The study tests the Stellate Ganglion Block (SGB), a procedure used for pain management that may reduce PTSD symptoms quickly. Participants will either receive SGB or a sham procedure to compare effectiveness, durability of effects, safety, and biological mechanisms behind SGB's potential benefits.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but could include risks associated with local anesthetics or complications from injections such as soreness, infection at the injection site, or allergic reactions.
SGB-PTSD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with chronic PTSD.
SGB-PTSD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks after sgb, sham, or wlc enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after sgb, sham, or wlc enrollment
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-5
Safety - Adverse Events and Side Effects from Treatment
Secondary outcome measures
Peripheral Psychophysiology Startle Response
SGB-PTSD Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: SGBActive Control1 Intervention
SGB, the experimental procedure, is the injection of 7 cc of 0.5% ropivacaine plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle
Group II: Wait-List Control (WLC)Active Control1 Intervention
WLC, a control for time, expectancy and safety, is all study procedures without going to the procedure room for injection
Group III: ShamPlacebo Group1 Intervention
Sham, the placebo control group, is the injection of 7 cc of normal saline plus 0.5 cc contrast anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,069 Total Patients Enrolled
Analydata, IncUNKNOWN
1 Previous Clinical Trials
92 Total Patients Enrolled
Michael Hollifield, MDPrincipal InvestigatorVA Long Beach Healthcare System, Long Beach, CA
2 Previous Clinical Trials
182 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been exposed to chemicals or trauma that affected my brain or mental health.I am currently in therapy for PTSD but can pause it if needed.I have had a stellate ganglion block (SGB) before.I am willing to keep my medication doses the same during the trial.I have been diagnosed with chronic PTSD.I have tried at least one recommended treatment for PTSD.I am able to make my own health decisions.I have a severe sleep disorder or often feel tired despite sleeping, or I often miss PTSD treatment sessions.My medication doses for mental health have been stable for the last 8 weeks.I have been on stable medication for over 8 weeks and can continue it during the trial.I have participated in emotional or drug-based therapy.I have severe depression, more significant than any PTSD symptoms.I do not have thyroid issues or other health conditions that would prevent me from receiving SGB treatment.I have tried at least one recommended treatment for PTSD.I am currently participating in therapy for my condition.I have been diagnosed with chronic PTSD.I am a woman or identify as part of a minority group.My medical records show I completed or couldn't finish therapy due to a strong dislike.I have participated in a therapy trial for emotional or behavioral issues.You have PTSD with a total CAPS-5 score of > 26.I have PTSD and may also experience anxiety or moderate depression.My medical records show I completed or couldn't finish therapy due to a strong dislike.I have tried at least one recommended treatment for PTSD.I am not taking any medications that could affect my study results.I need strong painkillers for my pain.My medical records show I completed or couldn't finish therapy due to a strong dislike.I have PTSD and may also experience anxiety or moderate depression.I am a woman or identify as part of a minority group.I have PTSD and may also experience anxiety or moderate depression.
Research Study Groups:
This trial has the following groups:- Group 1: SGB
- Group 2: Sham
- Group 3: Wait-List Control (WLC)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can I be included in the cohort of this medical experiment?
"This medical trial is recruiting 360 adults aged 18 to 55 who have stress disorders and/or trauma. To qualify, patients must verify an adequate dosage of evidence-based treatments (EBTs), a CAPS-5 score above 26, and engagement in such therapies either pharmaco-, or psycho-therapy respectively. Other comorbid symptoms such as moderate depression or anxiety do not disqualify potential participants from this study."
Answered by AI
Are new participants being enrolled for this clinical research?
"According to the clinicaltrials.gov page, this research is currently in progress and accepting new participants since its initial post date of October 17th 2022. The information was recently updated on October 19th 2022."
Answered by AI
Are there multiple centers in this city offering participation in the trial?
"Among the six clinical trial sites onboarding patients for this study are VA Salt Lake City Health Care System, White River Junction VA Medical Center, and VA Long Beach Healthcare System. Additionally, there is a triad of other medical centres that are participating in this endeavour."
Answered by AI
Does the study grant access to participants under twenty years of age?
"To participate in this medical trial, patients must be of legal age with an upper limit set at 55 years old. Alternative studies exist for those under 18 and over 65 respectively - 36 and 273 trials are available."
Answered by AI
How many participants are currently registered for this trial?
"Indeed, the information posted on clinicaltrials.gov confirms that this trial is open to participants. It was initially advertised on October 17th 2022 and last updated two days later. To date, 360 individuals have been accepted across 6 different locations."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Other
William S. Middleton Memorial Veterans Hospital, Madison, WI
Minneapolis VA Health Care System, Minneapolis, MN
VA Long Beach Healthcare System, Long Beach, CA
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I think my story is better told in person. I have been struggling for years with PTSD without relief. It feels as debilitating as it did 10 years ago and sometimes it even feels like it’s getting worse. I’ll try any therapy.
PatientReceived no prior treatments
I have episodes that at first I thought were panic attacks but are just a pure physical response without any cognitive triggers. I have an uninhibited sympathetic nervous system response that last intensely for 4 to 6 hours, and takes one to two days to recover. I have been told this is dysautonomia.
PatientReceived 2+ prior treatments
What I have severe PTSD, and spent five months at Rogers and patient PHPNIOP for trauma and have tried several different medication’s and I’m currently taking three medication‘s to help with my PTSD symptoms. Despite all these treatments, my symptoms have worsened and flared up more, and I would love to find relief of any sort.
PatientReceived no prior treatments
Recently I haven't been able to control the PTSD symptoms like I have before. Been turning to alcohol, sweets, unhealthy foods to cope with PTSD episodes and triggers which is not good since I was diagnosed with diabetes in June of 2023. A1c was 9.4 then 7.4 last lab result was 6.4 however, I have been back sliding, PTSD symptoms are more frequent lately.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- William S. Middleton Memorial Veterans Hospital, Madison, WI: < 24 hours
Average response time
- < 1 Day
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