What is the mechanism of action of this treatment?

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacological approaches like SSRIs and SNRIs, which increase serotonin and norepinephrine levels to improve mood and reduce anxiety. Non-pharmacological treatments such as Cognitive Behavioral Therapy (CBT) focus on altering negative thought patterns and behaviors. Stellate Ganglion Block (SGB) involves injecting a local anesthetic into the stellate ganglion, a nerve cluster in the neck, to modulate the sympathetic nervous system and decrease hyperarousal. Understanding these mechanisms is important for PTSD patients as it allows for personalized treatment plans that can more effectively alleviate symptoms and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for PTSD include cognitive processing therapy (CPT), prolonged exposure therapy (PE), and medications such as selective serotonin reuptake inhibitors (SSRIs). Side effects of CPT and PE are generally minimal but can include temporary increases in distress or anxiety as patients confront traumatic memories. SSRIs can cause side effects such as nausea, insomnia, dizziness, and sexual dysfunction. For treatments similar to Stellate Ganglion Block (SGB), which involves an injection of local anesthetic into the stellate ganglion, potential side effects include temporary pain at the injection site, infection, bleeding, and, rarely, nerve damage or pneumothorax. SGB aims to modulate the sympathetic nervous system to reduce hyperarousal and PTSD symptoms.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Post-Traumatic Stress Disorder (PTSD), primarily focusing on selective serotonin reuptake inhibitors (SSRIs) such as sertraline and paroxetine, and serotonin-norepinephrine reuptake inhibitors (SNRIs) like venlafaxine. These medications work by modulating neurotransmitter levels to alleviate symptoms of PTSD. While there are no FDA-approved treatments specifically targeting the sympathetic nervous system in the same way as Stellate Ganglion Block (SGB), the SGB procedure itself is being studied for its potential to reduce PTSD symptoms by decreasing hyperarousal through sympathetic nervous system modulation.

What other types of research exist?

Promising, novel alternatives to Stellate Ganglion Block (SGB) for PTSD treatment include: <ol> <li>Transcranial Magnetic Stimulation (TMS): This non-invasive procedure uses magnetic fields to stimulate nerve cells in the brain, which can help reduce PTSD symptoms by modulating brain activity.</li> <li>Ketamine Infusion Therapy: Ketamine, an NMDA receptor antagonist, has shown rapid and significant reduction in PTSD symptoms in some patients.</li> <li>MDMA-Assisted Psychotherapy: MDMA, used in controlled therapeutic settings, has shown promise in reducing PTSD symptoms by enhancing emotional processing and reducing fear responses.</li> <li>Virtual Reality Exposure Therapy (VRET): This therapy uses virtual reality to expose patients to trauma-related cues in a controlled environment, helping them process and reduce PTSD symptoms.</li> <li>Neurofeedback: This technique involves training patients to regulate their brain activity, which can help reduce PTSD symptoms by improving emotional regulation and reducing hyperarousal.</li> </ol>

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Stellate Ganglion Block + Cognitive Processing Therapy for PTSD

Phase 2

Waitlist Available

Led By Craig J Bryan, PsyD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of PTSD within the last month

18 years of age or older

Must not have

Impaired mental status that precludes the ability to provide informed consent

Prior SGB treatment or CPT treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if injecting a local anesthetic into the neck can help military personnel and veterans with PTSD when combined with standard therapy. The treatment targets the nerves that control stress responses to reduce anxiety symptoms. Participants will receive therapy and be randomly assigned to get the injection at different times. This method has been investigated in previous trials for its potential to reduce PTSD symptoms, showing some promise in symptom reduction.

Who is the study for?

This trial is for U.S. military personnel and veterans over 18 who can speak English and have been diagnosed with PTSD within the last month. They must be on stable psychotropic meds for 3 months. It's not for those with severe brain injuries, substance abuse issues, high suicide risk, schizophrenia, psychotic or bipolar disorders, or previous SGB or CPT treatment.

What is being tested?

The study tests if a Stellate Ganglion Block (SGB) can improve PTSD outcomes when combined with Cognitive Processing Therapy (CPT). Participants will receive CPT sessions over two weeks and SGB during or after therapy while their recovery progress is monitored.

What are the potential side effects?

While specific side effects are not listed here, generally SGB may cause temporary soreness at the injection site, drooping eyelids or red eyes temporarily due to nerve blockage near the neck area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with PTSD in the last month.

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I am 18 years old or older.

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My mental health medication dose has been the same for at least 3 months.

Exclusion Criteria

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

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I am able to understand and give consent for my treatment.

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I have previously received SGB or CPT treatment.

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I have had a moderate or severe brain injury.

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I am at a high risk of suicide and may need hospital care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, week 0, week 1, week 2, week 4, week 8, week 12, week 13, week 14, week 16, week 20, week 24, week 52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in PTSD symptom severity

Secondary study objectives

Change in anxiety symptom severity

Mental Depression

Change in good end-state functioning

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Stellate ganglion block (SGB) treatment during cognitive processing therapy (CPT)Experimental Treatment2 Interventions

Participants will receive 12 sessions of cognitive processing therapy (CPT) for PTSD combined with SGB during the first week of CPT.

Group II: SGB three months after completing CPTExperimental Treatment2 Interventions

Participant will receive 12 sessions of cognitive processing therapy (CPT) for PTSD and will receive SGB three months after completing the CPT sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Processing Therapy (CPT)

2019

Completed Phase 3

~1400

Stellate Ganglion Block

2020

Completed Phase 2

~250

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

Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacological approaches like SSRIs and SNRIs, which increase serotonin and norepinephrine levels to improve mood and reduce anxiety. Non-pharmacological treatments such as Cognitive Behavioral Therapy (CBT) focus on altering negative thought patterns and behaviors. Stellate Ganglion Block (SGB) involves injecting a local anesthetic into the stellate ganglion, a nerve cluster in the neck, to modulate the sympathetic nervous system and decrease hyperarousal. Understanding these mechanisms is important for PTSD patients as it allows for personalized treatment plans that can more effectively alleviate symptoms and improve quality of life.

Utility of Cervical Sympathetic Block in Treating Post-Traumatic Stress Disorder in Multiple Cohorts: A Retrospective Analysis.