The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study
Recruitment status was: Recruiting
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).
|Stress Disorders, Post-Traumatic||Procedure: Stellate ganglion block||Phase 2|
|Study Design:||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|
- Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
- Depression scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
- Anxiety scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
- Quality of life scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
- Biophysical responses [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]
|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)|
Procedure: Stellate ganglion block
- 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.
- 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.
- 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533610
|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 email@example.com|
|Principal Investigator: Michael T Alkire, MD|
|Principal Investigator:||Michael T Alkire, MD||Long Beach VA Healthcare system|