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

February 14, 2012 updated by: Southern California Institute for Research and Education

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).

Study Overview

Status

Unknown

Conditions

Stress Disorders, Post-Traumatic

Intervention / Treatment

Procedure: Stellate ganglion block

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Long Beach, California, United States, 90803
    - Recruiting
    - VA Long Beach Healthcare System
    - Contact:
      
      Michael T Alkire, MD
      
      Phone Number: 4405 562-826-8000
      
      Email: malkire@uci.edu
    - Principal Investigator:
      
      Michael T Alkire, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern California Institute for Research and Education

Investigators

Principal Investigator: Michael T Alkire, MD, Long Beach VA Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

February 1, 2013

Study Completion (Anticipated)