Research Study Examining Nerve Block for Migraine

This study has been completed.

First Received: September 13, 2005 Last Updated: January 22, 2009 History of Changes

Sponsored by:	Thomas Jefferson University
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00203346

Purpose

Migraine and the skin sensitivity that accompanies it can go away in minutes after a nerve block, which is a procedure involving an injection of a small amount of a local anesthetic next to a nerve to the skin, causing an area of skin to become numb. We have also noticed that light sensitivity goes away quickly after a nerve block. We would like to see how quickly this happens and how long the benefit of nerve block lasts. We are interested to see if these effects are due to the injection itself or due to the lidocaine.

A subject may be asked to participate in this study if a subjects physician has planned for a subject to receive an injection of BOTOX® in the area of the Greater Occipital Nerve (a spinal nerve located at the back of the head) as part of a subjects routine preventive treatment for migraine today.

Condition	Intervention
Migraine	Procedure: Greater Occipital Nerve Block

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Greater Occipital Nerve (GON) Block for Migraine

Further study details as provided by Thomas Jefferson University:

Estimated Enrollment:	30
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects with episodic or transformed migraine age 18to 80 years old.
Subjects must have unilateral migraine headache and trigeminal distribution brush allodynia at the time of injection.
Subjects must be able to consent or assent to the study.

Exclusion Criteria:

Subjects who in their own or in the investigator's opinion are unable to report the severity of four symptoms (pin sharpness to determine efficacy of nerve block, headache severity, photophobia severity and allodynia severity), every 30 seconds for 5 minutes post injection;
Subjects with skull defect, or history of injury to the area of the GON.
Subjects with prior adverse reaction to GON block, lidocaine or marcaine.
Subjects who are pregnant or lactating

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00203346

Locations

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Investigators

Principal Investigator:

William B Young, MD

Thomas Jefferson University, Jefferson Headache Center

More Information

No publications provided

Study ID Numbers:	WBY/GON
Study First Received:	September 13, 2005
Last Updated:	January 22, 2009
ClinicalTrials.gov Identifier:	NCT00203346 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Migraine Disorders
Nervous System Diseases
Central Nervous System Diseases

Headache Disorders, Primary
Brain Diseases
Headache Disorders

ClinicalTrials.gov processed this record on May 07, 2009