Clinical trial NCT01533610: The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) Therapy: A Pilot Study
Official title: The Efficacy of Stellate Ganglion Block as PTSD Therapy: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stress Disorders, Post-Traumatic
Keywords: Post-Traumatic Stress disorder
Stellate ganglion
cervical plexus
local anesthesia
anxiety
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Difference in CAPS score activity
timeFrame: Baseline and weeks 1, 4, 12 and 26
Secondary outcomes:
measure: Depression scale
timeFrame: Baseline and weeks 1, 4, 12 and 26
measure: Anxiety scale
timeFrame: Baseline and weeks 1, 4, 12 and 26
measure: Quality of life scale
timeFrame: Baseline and weeks 1, 4, 12 and 26
measure: Biophysical responses
timeFrame: Baseline and weeks 1, 4, 12 and 26
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare system
state: California
Study officials:
affiliation: Long Beach VA Healthcare system
name: Michael T Alkire, MD
role: PRINCIPAL_INVESTIGATOR
References: