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

Primary Purpose

Stress Disorders, Post-Traumatic

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Stellate ganglion block

About this trial

This is an interventional supportive care trial for Stress Disorders, Post-Traumatic focused on measuring Post-Traumatic Stress disorder, Stellate ganglion, cervical plexus, local anesthesia, anxiety

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

VA Long Beach Healthcare systemRecruiting

Outcomes

Primary Outcome Measures

Difference in CAPS score activity

Secondary Outcome Measures

Depression scale

Anxiety scale

Quality of life scale

Biophysical responses

Full Information

NCT ID

NCT01533610

First Posted

February 12, 2012

Last Updated

February 14, 2012

Sponsor

Southern California Institute for Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT01533610

Brief Title

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

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

February 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Southern California Institute for Research and Education

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress Disorders, Post-Traumatic

Keywords

Post-Traumatic Stress disorder, Stellate ganglion, cervical plexus, local anesthesia, anxiety

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Stellate ganglion block

Other Intervention Name(s)

Cervical plexus block

Intervention Description

Local anesthesia applied to the stellate ganglion in the neck

Primary Outcome Measure Information:

Title

Difference in CAPS score activity

Time Frame