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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
Must not have
Thyroid disease and other contraindications to SGB (anatomic abnormalities of the anterior cervical spine; cardiac/pulmonary compromise; acute illness/infection; coagulopathy/bleeding disorder; allergic reactions/contraindications to local anesthetic or contrast dye, prior anterior neck surgery, anterior neck skin abnormalities (rash or eruptions))
Decisional incapacity (e.g., dementia, clear evidence of testing that signifies incapacity to consent), OR Montreal Cognitive Assessment score <18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks after sgb, sham, or wlc enrollment
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have thyroid issues or other health conditions that would prevent me from receiving SGB treatment.
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I am able to make my own health decisions.
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I need strong painkillers for my pain.
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I have been exposed to chemicals or trauma that affected my brain or mental health.
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I have had a stellate ganglion block (SGB) before.
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I am willing to keep my medication doses the same during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks after sgb, sham, or wlc enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks after sgb, sham, or wlc enrollment for reporting.

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Post-Traumatic Stress Disorder (PTSD) treatments often target the dysregulated sympathetic nervous system, which is responsible for the 'fight or flight' response. Stellate Ganglion Block (SGB) modulates this system by blocking nerve signals, potentially reducing hyperarousal and anxiety symptoms. Similarly, SSRIs (Selective Serotonin Reuptake Inhibitors) work by increasing serotonin levels in the brain, which can help stabilize mood and reduce anxiety. Cognitive-behavioral therapy (CBT) focuses on altering negative thought patterns and behaviors associated with trauma. These treatments are crucial for PTSD patients as they address both the physiological and psychological aspects of the disorder, offering a comprehensive approach to symptom management and improving overall quality of life.
PTSD: from neurobiology to pharmacological treatments.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,619 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

Stellate Ganglion Block Clinical Trial Eligibility Overview. Trial Name: NCT05169190 — N/A
Post-Traumatic Stress Disorder Research Study Groups: SGB, Sham, Wait-List Control (WLC)
Post-Traumatic Stress Disorder Clinical Trial 2023: Stellate Ganglion Block Highlights & Side Effects. Trial Name: NCT05169190 — N/A
Stellate Ganglion Block 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169190 — N/A
~60 spots leftby Dec 2024