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

February 12, 2012
February 14, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01533610 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study
The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study

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).

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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Stress Disorders, Post-Traumatic
Procedure: Stellate ganglion block
Local anesthesia applied to the stellate ganglion in the neck
Other Name: Cervical plexus block
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
February 2013
February 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
United States
 
NCT01533610
#1125
No
Southern California Institute for Research and Education
Southern California Institute for Research and Education
Not Provided
Principal Investigator: Michael T Alkire, MD Long Beach VA Healthcare system
Southern California Institute for Research and Education
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP