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

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01533610
• Other study ID #: #1125
• Status: Recruiting
• Phase: Phase 2
• First received: February 12, 2012
• Last updated: February 14, 2012
• Start date: February 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2012
• Source: Southern California Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Procedure:
• Stellate ganglion block
Local anesthesia applied to the stellate ganglion in the neck

Locations

Country	Name	City	State
United States	VA Long Beach Healthcare system	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Southern California Institute for Research and Education

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in CAPS score activity		Baseline and weeks 1, 4, 12 and 26	No
Secondary	Depression scale		Baseline and weeks 1, 4, 12 and 26	No
Secondary	Anxiety scale		Baseline and weeks 1, 4, 12 and 26	No
Secondary	Quality of life scale		Baseline and weeks 1, 4, 12 and 26	No
Secondary	Biophysical responses		Baseline and weeks 1, 4, 12 and 26	No