Stellate Ganglion Block + Therapy for PTSD
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Must not be taking: Anticoagulants, Class III antiarrhythmics
Disqualifiers: Suicidal ideation, Manic episode, Substance use, Pregnancy, others
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anticoagulants or Class III antiarrhythmics.
What data supports the effectiveness of the treatment Stellate Ganglion Block + Therapy for PTSD?
Research shows that stellate ganglion block (SGB), which involves injecting a local anesthetic like ropivacaine into the neck, has been successfully used to reduce symptoms of PTSD in several studies, including cases with combat-related PTSD. This treatment has been effective in providing immediate relief from anxiety symptoms associated with PTSD.
12345Is Stellate Ganglion Block (SGB) safe for humans?
The Stellate Ganglion Block (SGB) procedure, which involves an injection in the neck to help manage stress responses, has been studied for safety and patient acceptability in treating PTSD symptoms. It is generally considered safe as an outpatient procedure, with studies focusing on its use in military personnel with PTSD.
23456How does the stellate ganglion block treatment for PTSD differ from other treatments?
Stellate ganglion block (SGB) is unique because it involves an injection of a local anesthetic in the neck to temporarily block nerves that control the body's fight-or-flight response, providing immediate relief from PTSD symptoms. Unlike traditional PTSD treatments, SGB is a quick outpatient procedure with minimal side effects and has been used successfully for other conditions like chronic pain.
12345Eligibility Criteria
This trial is for active duty and retired military service members aged 18-65 with PTSD, who can speak and read English. They must be eligible to receive care at a military treatment facility where the neck injection will take place.Inclusion Criteria
I have been diagnosed with PTSD by a professional.
Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.
Able to speak and read English (due to standardization of outcome measures)
+1 more
Exclusion Criteria
I am currently taking blood thinners.
Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider
Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive Massed Prolonged Exposure therapy and either a stellate ganglion block or a sham injection
2 weeks
10 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
3 visits (in-person) at 1-, 3-, and 6-months posttreatment
Booster Sessions
Participants are offered three booster sessions to reinforce treatment
7 weeks
3 visits (in-person) at 1-, 3-, and 7-weeks posttreatment
Participant Groups
The study tests if adding a stellate ganglion block (a local anesthetic neck injection) to Massed Prolonged Exposure therapy improves PTSD outcomes compared to the same therapy with a sham injection.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Stellate Ganglion BlockExperimental Treatment1 Intervention
One time administration of a stellate ganglion block
Group II: Sham SGBPlacebo Group1 Intervention
One time administration
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Health Science Center at San AntonioSan Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
United States Department of DefenseCollaborator
References
A review of the use of stellate ganglion block in the treatment of PTSD. [2018]Current treatments for PTSD are often not effective or acceptable to the patient. There are a number of emerging new treatments. One promising new one is stellate ganglion block, an anesthetic treatment for pain which relieves symptoms of severe and chronic PTSD in some patients. The focus of this chapter is to summarize clinical evidence available for the effectiveness of cervical sympathetic ganglion injection called stellate ganglion block (SGB), as well as demonstrate possible clinical applications of its use. Cervical sympathetic blockade involves injecting a local anesthetic next to a group of nerves (ganglion) in the neck. The technique has been used clinically since 1925 with very few side effects. Finally, the neurobiology of SGB is discussed. Challenges to the use of SGB include the lack of randomized clinical trials and practitioners familiar with the use of SGB for PTSD.
The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. [2022]Ultrasound-guided stellate ganglion block (SGB) is an injection of local anesthetic (8mL of 0.5% ropivacaine) in the neck to temporarily block the cervical sympathetic trunk which controls the body's fight-or-flight response. This outpatient procedure takes less than thirty minutes and is immediately effective. Our goal was to determine if a left-sided stellate ganglion block is effective for treating posttraumatic stress disorder (PTSD) symptoms. While right-sided SGB has been extensively studied, left-sided SGB has not been formally evaluated for this indication.
The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. [2022]Report the successful use of stellate ganglion blocks (SGBs) in two patients experiencing symptoms of post-traumatic stress disorder (PTSD).
Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. [2018]Report the successful use of stellate ganglion blocks (SGBs) in 166 active duty service members with multiple combat deployments experiencing anxiety symptoms associated with post-traumatic stress disorder (PTSD).
Efficacy of stellate ganglion block in the treatment of anxiety symptoms from combat-related post-traumatic stress disorder: a case series. [2017]Report the efficacious use of stellate ganglion blocks (SGBs) in treating the anxiety symptoms of four patients diagnosed with combat-related post-traumatic stress disorder (PTSD) and discuss possible mechanisms of action to explain these findings.
Safety and Patient Acceptability of Stellate Ganglion Blockade as a Treatment Adjunct for Combat-Related Post-Traumatic Stress Disorder: A Quality Assurance Initiative. [2020]To perform a quality assurance and performance improvement project through review of our single center data on the safety and patient acceptability of the stellate ganglion blockade (SGB) procedure for the relief of symptoms related to chronic post-traumatic stress disorder.