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

This study is currently recruiting participants.

Verified February 2012 by Southern California Institute for Research and Education

Sponsor:

Information provided by (Responsible Party):

Southern California Institute for Research and Education

ClinicalTrials.gov Identifier:

NCT01533610

First received: February 12, 2012

Last updated: February 14, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

February 12, 2012

Last Updated Date

February 14, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01533610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Depression scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
Anxiety scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
Quality of life scale [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]
Biophysical responses [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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:

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Stress Disorders, Post-Traumatic

Intervention ^ICMJE

Procedure: Stellate ganglion block

Local anesthesia applied to the stellate ganglion in the neck

Other Name: Cervical plexus block

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01533610

Other Study ID Numbers ^ICMJE

#1125

Has Data Monitoring Committee

Responsible Party

Southern California Institute for Research and Education

Study Sponsor ^ICMJE

Southern California Institute for Research and Education

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael T Alkire, MD

Long Beach VA Healthcare system

Information Provided By

Southern California Institute for Research and Education

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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