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


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Stress Disorders, Post-Traumatic

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Difference in CAPS score activity

Outcome Time Frame:

Baseline and weeks 1, 4, 12 and 26

Safety Issue:

No

Principal Investigator

Michael T Alkire, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Long Beach VA Healthcare system

Authority:

United States: Federal Government

Study ID:

#1125

NCT ID:

NCT01533610

Start Date:

February 2012

Completion Date:

February 2013

Related Keywords:

  • Stress Disorders, Post-traumatic
  • Post-Traumatic Stress disorder
  • Stellate ganglion
  • cervical plexus
  • local anesthesia
  • anxiety
  • Synovial Cyst
  • Ganglion Cysts
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic

Name

Location
Va Long Beach Healthcare System Long Beach, California  90822