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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Southern California Institute for Research and Education.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Southern California Institute for Research and Education
ClinicalTrials.gov Identifier:
NCT01533610
First received: February 12, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Stress Disorders, Post-Traumatic
Procedure: Stellate ganglion block
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Southern California Institute for Research and Education:

Primary Outcome Measures:
  • Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
  • Anxiety scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
  • Quality of life scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
  • Biophysical responses [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: February 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Stellate ganglion block
    Local anesthesia applied to the stellate ganglion in the neck
    Other Name: Cervical plexus block
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Southern California Institute for Research and Education
ClinicalTrials.gov Identifier: NCT01533610     History of Changes
Other Study ID Numbers: #1125
Study First Received: February 12, 2012
Last Updated: February 14, 2012
Health Authority: United States: Federal Government

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:
Disease
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014