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

Study Overview
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Brief Summary
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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).

Detailed Description
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Objectives: 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. 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.

Official Title
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The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study

Conditions
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Stress Disorders, Post-Traumatic

Intervention / Treatment
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* Procedure: Stellate ganglion block


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Stellate ganglion block|Local anesthesia applied to the stellate ganglion in the neck|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in CAPS score activity |  | Baseline and weeks 1, 4, 12 and 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scale |  | Baseline and weeks 1, 4, 12 and 26 | 
| Anxiety scale |  | Baseline and weeks 1, 4, 12 and 26 | 
| Quality of life scale |  | Baseline and weeks 1, 4, 12 and 26 | 
| Biophysical responses |  | Baseline and weeks 1, 4, 12 and 26 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-Traumatic Stress disorder, Stellate ganglion, cervical plexus, local anesthesia, anxiety