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Clinical Trials/NCT01629537
NCT01629537
Completed
Phase 2

A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder

United States Naval Medical Center, San Diego1 site in 1 country41 target enrollmentJune 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post Traumatic Stress Disorder (PTSD)
Sponsor
United States Naval Medical Center, San Diego
Enrollment
41
Locations
1
Primary Endpoint
Clinician Administered PSTD Scale (CAPS)
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
United States Naval Medical Center, San Diego
Responsible Party
Principal Investigator
Principal Investigator

Steven Hanling

Department of Psychaitry Research Director, Mental Health Directorate

United States Naval Medical Center, San Diego

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinician Administered PSTD Scale (CAPS)

Time Frame: 1 week

The CAPS is generally considered the gold standard for PTSD assessment, and will be used to determine severity of PTSD symptoms compared to the 1 week pre baseline measures at enrollment

Secondary Outcomes

  • Sheehan Disability Scale (SDS)(1 week)
  • Behavioral Reactivity Test (BRT)(1 week)
  • PTSD Checklist Military Version (PCL-M)(1 week)
  • Beck Anxiety Inventory (BAI)(1 week)
  • Automated Neuropsychological Assessment Metric (ANAM)(1 week)
  • The Patient Health Questionnaire 9 (PHQ-9)(1 week)

Study Sites (1)

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