What side effects are associated with this type of intervention?

Common treatments for PTSD that modulate the sympathetic nervous system include medications like selective serotonin reuptake inhibitors (SSRIs) and therapies such as cognitive-behavioral therapy (CBT). SSRIs can cause side effects such as nausea, insomnia, dizziness, and sexual dysfunction. Cognitive-behavioral therapy is generally well-tolerated but may cause temporary increases in anxiety or distress as patients confront traumatic memories. Stellate Ganglion Block (SGB), a newer treatment under study, has shown promise but may have side effects including temporary pain at the injection site, Horner's syndrome (drooping eyelid, constricted pupil), and, rarely, infection or nerve damage.

What prior FDA approvals exist?

As of now, the FDA has not approved any treatments for PTSD that specifically target the modulation of the sympathetic nervous system like Stellate Ganglion Block (SGB). The primary FDA-approved treatments for PTSD include selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine. These medications work by altering neurotransmitter levels in the brain to help manage symptoms. Other treatments, such as cognitive-behavioral therapy (CBT), are also commonly used but do not involve direct modulation of the sympathetic nervous system.

What other types of research exist?

Promising, novel alternatives to Stellate Ganglion Block (SGB) for PTSD patients include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain and has shown efficacy in reducing PTSD symptoms. 2) Vagal Nerve Stimulation (VNS), which involves electrical stimulation of the vagus nerve and has been associated with reduced headache burden and potential benefits for PTSD. 3) Dorsal Root Ganglion (DRG) Stimulation, which modulates neuropathic pain signals and may have applications in treating PTSD symptoms. These treatments offer non-invasive or minimally invasive options for modulating the nervous system to alleviate PTSD symptoms.

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Stellate Ganglion Block for PTSD (SGB-PTSD Trial)

Q: What is the mechanism of action of this treatment?

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.

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

Summary

This trial tests if an injection near neck nerves can help Veterans with chronic PTSD who need alternative treatments. The injection may calm overactive nerves, reducing PTSD symptoms quickly. This method has been explored for treating various conditions, including PTSD, with mixed evidence.

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.

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.

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

Select...

I have been diagnosed with chronic PTSD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have thyroid issues or other health conditions that would prevent me from receiving SGB treatment.

Select...

I am able to make my own health decisions.

Select...

I need strong painkillers for my pain.

Select...

I have been exposed to chemicals or trauma that affected my brain or mental health.

Select...

I have had a stellate ganglion block (SGB) before.

Select...

I am willing to keep my medication doses the same during the 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Administered PTSD Scale-5

Safety - Adverse Events and Side Effects from Treatment

Secondary study objectives

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

0 / 7Eligibility criteria met

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.