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Stellate Ganglion Block for Post-Traumatic Stress Disorder

Phase 2
Recruiting
Led By Alan Peterson, PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at 1-month, 3-month, and 6-month follow-up assessments
Awards & highlights

Study Summary

"This trial aims to see if combining Massed Prolonged Exposure therapy with a stellate ganglion block injection is more effective in treating PTSD in military service members compared to just the therapy with

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects from the Ropivacaine injection include soreness or bruising at the injection site, dizziness, nausea, or numbness. The saline sham may cause discomfort but no medicinal side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at 1-month, 3-month, and 6-month follow-up assessments
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at 1-month, 3-month, and 6-month follow-up assessments for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5)
Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5)
Secondary outcome measures
General Anxiety Disorder Screener - 7 Items (GAD-7)
Patient Health Questionnaire-9 items (PHQ-9)
Posttraumatic Cognitions Inventory (PTCI)
+7 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine injection
2012
Completed Phase 4
~510

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
453 Previous Clinical Trials
91,290 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,559 Total Patients Enrolled
Alan Peterson, PhDPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
2 Previous Clinical Trials
772 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for individuals seeking to participate in this clinical study?

"Candidates seeking to participate in this clinical trial must be afflicted with post-traumatic stress disorder and fall within the age range of 18 to 65 years. A total of 140 participants are being sought for recruitment into the study."

Answered by AI

Are there any available openings for patients to participate in this study?

"Indeed, information from clinicaltrials.gov confirms the active recruitment status of this investigation. The trial was initially listed on 26th February 2024 and most recently revised on 28th February 2024. Recruitment is underway for a total of 140 participants at one designated site."

Answered by AI

Is there eligibility for participants under the age of 45 in this medical study?

"To be eligible for this trial, potential participants must have reached the age of consent but not exceed 65 years old."

Answered by AI

What is the total number of participants being recruited for this research endeavor?

"Yes, information on clinicaltrials.gov highlights that this study is actively seeking eligible individuals. This trial was initially posted on February 26th, 2024 and had its latest update on February 28th, 2024. The aim is to enroll a total of 140 participants from one designated site."

Answered by AI

Has the FDA given its official authorization for the use of Stellate Ganglion Block?

"As per our evaluation at Power, the safety rating for Stellate Ganglion Block stands at 2 on a scale of 1 to 3. This assessment is based on the current Phase 2 trial data which indicates some degree of safety but lacks evidence regarding efficacy."

Answered by AI

What is the main objective of this medical study?

"The principal aim of this investigation, to be scrutinized during baseline and at 1-month, 3-month, and 6-month follow-up evaluations is the alteration in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5) scores from initiation. Secondary objectives incorporate changes in Psychophysiological arousal assessed via Interbeat Interval derived from smartwatch data, alterations in self-blame and negative cognitions as measured by the Posttraumatic Cognitions Inventory (PTCI), which ranges between a score of 33 to 231 with higher values indicating more severe maladaptive beliefs; additionally, shifts in skin temperature recorded through"

Answered by AI
~93 spots leftby Mar 2026