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

NCT ID: NCT01533610

Last Updated: 2012-02-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-02-28

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.

Conditions

Stress Disorders, Post-Traumatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

Stellate ganglion block

Local anesthesia applied to the stellate ganglion in the neck

Intervention Type: PROCEDURE

Other Intervention Names

Cervical plexus block

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Southern California Institute for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael T Alkire, MD

Role: PRINCIPAL_INVESTIGATOR

Long Beach VA Healthcare system

Locations

VA Long Beach Healthcare system

Long Beach, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Michael T Alkire, MD

Role: primary

malkire@uci.edu

562-826-8000 ext. 4405

Other Identifiers

#1125

Identifier Type: -

Identifier Source: org_study_id