What side effects are associated with this type of intervention?

Common treatments for PTSD include Cognitive Processing Therapy (CPT), SSRIs, and SNRIs. CPT is generally well-tolerated but can cause emotional distress as patients confront traumatic memories. SSRIs and SNRIs, such as sertraline and venlafaxine, are effective but may cause side effects like nausea, insomnia, sexual dysfunction, and increased anxiety. The Stellate Ganglion Block (SGB) treatment, which involves a local anesthesia injection, has shown promise in reducing PTSD symptoms but can cause temporary side effects such as pain at the injection site, Horner's syndrome, and, rarely, infection or bleeding.

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. These medications work by altering neurotransmitter levels to help manage symptoms of PTSD. While the Stellate Ganglion Block (SGB) treatment, which involves blocking pain signal transmissions, is being studied for its potential to reduce PTSD symptoms, it is not yet FDA-approved for this indication. Current FDA-approved treatments do not specifically target pain signal transmission in the same way as SGB.

What other types of research exist?

One promising alternative to Stellate Ganglion Block for PTSD patients is Cognitive Processing Therapy (CPT). Although not novel, it is an evidence-based first-line treatment. Combining CPT with other interventions, such as pharmacotherapy or emerging neuromodulation techniques, may enhance its effectiveness. For instance, transcranial magnetic stimulation (TMS) has shown potential in other contexts and could be explored further for PTSD treatment.

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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

Must not have

They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 12 months or are currently receiving an evidence-based PTSD treatment

They have an active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, on average of 3 months

Summary

This trial tests whether combining Cognitive Processing Therapy (CPT) with Stellate Ganglion Block (SGB) can better help people with PTSD. CPT is a talk therapy, and SGB is an injection that numbs nerves in the neck to reduce symptoms. Stellate Ganglion Block (SGB) has been investigated in trials for its potential to reduce PTSD symptoms, showing some promise in symptom reduction.

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.

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.

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.

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 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.

Exclusion Criteria

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

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I have completed or am currently in a recognized PTSD therapy program.

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I currently have an active infection.

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I am allergic to certain medications like ropivacaine, lidocaine, or propofol.

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I do not have any hearing or vision problems that would stop me from joining in the study activities.

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I am taking blood-thinning medication or have a bleeding disorder.

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I have not had a recent heart attack, glaucoma, nerve palsy, severe emphysema, or heart rhythm problems.

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I experienced a traumatic event within the last month.

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I have a serious health condition that might require hospitalization soon.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, on average of 3 months 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 for DSM-5

PTSD Checklist for DSM-5 Criteria

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Stellate Ganglion BlockActive Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 12Eligibility 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) work through various mechanisms to alleviate symptoms. Stellate Ganglion Block (SGB) reduces PTSD symptoms by blocking pain signal transmissions via local anesthesia to the stellate ganglion. Cognitive Processing Therapy (CPT) helps patients reframe negative thoughts related to trauma, thereby reducing emotional distress. Medications like prazosin target alpha-adrenergic receptors to reduce nightmares and improve sleep quality. Understanding these mechanisms is important for PTSD patients as it allows for personalized treatment plans that address specific symptoms, leading to better management and improved quality of life.

Nonconventional interventions for chronic post-traumatic stress disorder: Ketamine, repetitive trans-cranial magnetic stimulation (rTMS), and alternative approaches.