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Stellate Ganglion Block (SGB) for PTSD

Phase 2
Waitlist Available
Led By Steven Hanling, MD, CDR
Research Sponsored by United States Naval Medical Center, San Diego
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 1 week

Summary

Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or impairment in social, occupational or other important aspects of functioning. The occurrence of PTSD in the military is on the rise. This has significantly impacted military members, their families, and society as a whole. According to an expert panel convened by the Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is low. Safe and effective treatments are urgently needed. The specific aim of this investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms, utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention for PTSD treatment. Participants will be randomized to receive either the SGB with local anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to the neck. The PTSD symptoms before and after the procedure will be measured using a comprehensive clinician-administered scale, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment prior to the procedure, one week following the procedure, one month and 3 months following the procedure. Patients receiving sham injections will be allowed to cross over to the treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in reduction of PTSD symptoms as measured by clinician-administered scales, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures, leading to a significant and lasting reduction of PTSD symptoms.

Eligible Conditions
  • PTSD

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week 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 PSTD Scale (CAPS)
Secondary study objectives
Automated Neuropsychological Assessment Metric (ANAM)
Beck Anxiety Inventory (BAI)
Behavioral Reactivity Test (BRT)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Stellate Ganglion Block (SGB)Experimental Treatment1 Intervention
Subjects assigned to SGB arm will undergo SGB procedure and be followed one week, one month and three months after procedure or until CAPS score is below 40.
Group II: PlaceboExperimental Treatment1 Intervention
Subjects 1 month post in the placebo group who demonstrate either the same level of PTSD severity at enrollment or worsening of the condition (i.e., CAPS score greater than or equal to 40) will be offered SGB treatment and crossed over to active treatment. Patients who cross over from placebo to active SGB treatment will be followed one week, one month and three months after cross over.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stellate Ganglion Block injection with ropivicane
2011
Completed Phase 2
~50
Placebo Procedure
2011
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, San DiegoLead Sponsor
108 Previous Clinical Trials
23,110 Total Patients Enrolled
Steven Hanling, MD, CDRPrincipal InvestigatorUnited States Naval Medical Center, San Diego
~3 spots leftby Nov 2025