NCT01533610

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 15, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

February 12, 2012

Last Update Submit

February 14, 2012

Conditions

Stress Disorders, Post-Traumatic

Keywords

Post-Traumatic Stress disorderStellate ganglioncervical plexuslocal anesthesiaanxiety

Outcome Measures

Primary Outcomes (1)

  • Difference in CAPS score activity

    Baseline and weeks 1, 4, 12 and 26

Secondary Outcomes (4)

  • Depression scale

    Baseline and weeks 1, 4, 12 and 26

  • Anxiety scale

    Baseline and weeks 1, 4, 12 and 26

  • Quality of life scale

    Baseline and weeks 1, 4, 12 and 26

  • Biophysical responses

    Baseline and weeks 1, 4, 12 and 26

Interventions

Stellate ganglion blockPROCEDURE

Local anesthesia applied to the stellate ganglion in the neck

Also known as: Cervical plexus block

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Long Beach Healthcare system

Long Beach, California, 90803, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety Disorders

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Michael T Alkire, MD

    Long Beach VA Healthcare system

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2012

First Posted

February 15, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 15, 2012

Record last verified: 2012-02

Locations

US(1)