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The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study

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ClinicalTrials.gov Identifier: NCT01533610
Recruitment Status : Unknown
Verified February 2012 by Southern California Institute for Research and Education.
Recruitment status was:  Recruiting
First Posted : February 15, 2012
Last Update Posted : February 15, 2012
Sponsor:
Information provided by (Responsible Party):
Southern California Institute for Research and Education

Brief Summary:

RATIONALE: A stellate ganglion nerve block may help relieve symptoms of post-traumatic stress disorder (PTSD).

PURPOSE: This pilot clinical trial is studying the efficacy of a stellate ganglion nerve block in veterans to reduce the symptoms of PTSD in relatively long-standing (Vietnam era) induced or relatively recently induced PTSD (from deployment in Afghanistan or Iraq as part of Operations Enduring Freedom (OEF), Iraqi Freedom (OIF), and New Dawn (OND).


Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Procedure: Stellate ganglion block Phase 2

Detailed Description:

Objectives:

  1. Stellate ganglion blocks will be performed in a small sample (n = 12) of the local patient population that suffers from PTSD in order to replicate other preliminary findings.
  2. The parameters that lead to a successful treatment response will be evaluated by comparing and contrasting the results obtained in younger (n=6) OEF/OIF generation veterans versus older (n=6) Vietnam generation veterans.
  3. The individual difference variables that might lead to successful treatment responses will be studied by obtaining correlative measures of psychological and psychometric data and responses to standardized tests.

Research Design:

This is an open label unblinded clinical pilot case series study to determine the efficacy of stellate ganglion blockade for relief of PTSD symptoms in the Long Beach VA healthcare population.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study
Study Start Date : February 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Stellate ganglion block
    Local anesthesia applied to the stellate ganglion in the neck
    Other Name: Cervical plexus block


Primary Outcome Measures :
  1. Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]

Secondary Outcome Measures :
  1. Depression scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
  2. Anxiety scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
  3. Quality of life scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
  4. Biophysical responses [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Include significant PTSD symptoms with severe hyper-arousal symptoms.
  • Clinician Administered PTSD Scales (CAPS) score, with a total score ≥ 50 needed for enrollment.
  • Hyper-arousal severity identified by a high score on the CAPS D scale and a ≥ 10 beat per minute increase in heart rate during the subject's verbal recollection of a standardized version of their traumatic exposure.

Exclusion Criteria:

  • Include psychiatric and medical conditions that would make patients poor candidates for an outpatient procedure.
  • Subjects must be able to be cooperative for the procedure and free of significant medical problems that would pose a constant threat to life.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533610


Locations
United States, California
VA Long Beach Healthcare system Recruiting
Long Beach, California, United States, 90803
Contact: Michael T Alkire, MD    562-826-8000 ext 4405    malkire@uci.edu   
Principal Investigator: Michael T Alkire, MD         
Sponsors and Collaborators
Southern California Institute for Research and Education
Investigators
Principal Investigator: Michael T Alkire, MD Long Beach VA Healthcare system

Responsible Party: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01533610     History of Changes
Other Study ID Numbers: #1125
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: February 15, 2012
Last Verified: February 2012

Keywords provided by Southern California Institute for Research and Education:
Post-Traumatic Stress disorder
Stellate ganglion
cervical plexus
local anesthesia
anxiety

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Ganglion Cysts
Trauma and Stressor Related Disorders
Mental Disorders
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases