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

Southern California Institute for Research and Education

Status and phase

Unknown

Phase 2

Conditions

Stress Disorders, Post-Traumatic

Treatments

Procedure: Stellate ganglion block

Study type

Interventional

Funder types

Other

Identifiers

NCT01533610

#1125

Details and patient eligibility

About

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).

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.