Recruiting
Phase 2

Stellate Ganglion Block

Sponsor:

Southern California Institute for Research and Education

Code:

NCT01533610

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Stellate ganglion block

Study Details

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).

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT01533610

Start date

Feb, 2012

Status verified date

Feb, 2012

Completion date

Feb, 2013

Anticipated

Primary completion date

Feb, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Interventions

Stellate ganglion block

Local anesthesia applied to the stellate ganglion in the neck

Primary outcome measure

  • Difference in CAPS score activity [ Time Frame: Baseline and weeks 1, 4, 12 and 26 ]

Central Contacts and Locations

Locations

VA Long Beach Healthcare system

Recruiting

Long Beach, California, United States, 90803

Contacts

Michael T Alkire, MD

562-826-8000malkire@uci.edu

Principal Investigator:

Michael T Alkire, MD

More Information

Sponsor

Southern California Institute for Research and Education

Last update posted

Feb 15, 2012

Last verified

Feb, 2012

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Southern California Institute for Research and Education on 2012-02-15.