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
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|
- 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.
|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|
- Procedure: Stellate ganglion block
Local anesthesia applied to the stellate ganglion in the neckOther Name: Cervical plexus block
- 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 ]
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
|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 firstname.lastname@example.org|
|Principal Investigator: Michael T Alkire, MD|
|Principal Investigator:||Michael T Alkire, MD||Long Beach VA Healthcare system|