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

Phase 2

• Conditions: Stress Disorders, Post-Traumatic

• Registration Number: NCT01533610
• Lead Sponsor: Southern California Institute for Research and Education

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-02
• Study First Submitted: 2012-02-12
• Study First Submitted QC: 2012-02-14
• Last Update Submitted: 2012-02-14
• Study First Posted: 2012-02-15
• Last Update Posted: 2012-02-15
• Primary Completion: 2013-02
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Difference in CAPS score activity	Baseline and weeks 1, 4, 12 and 26

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

VA Long Beach Healthcare system; 🇺🇸 Long Beach, California, United States