Research Study Examining Nerve Block for Migraine

This study has been completed.

Sponsor:

Information provided by:

Thomas Jefferson University

ClinicalTrials.gov Identifier:

NCT00203346

First received: September 13, 2005

Last updated: January 22, 2009

Last verified: January 2009

History of Changes

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


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

Resource links provided by NLM:

MedlinePlus related topics: Migraine

U.S. FDA Resources

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00203346 History of Changes
Other Study ID Numbers:	WBY/GON
Study First Received:	September 13, 2005
Last Updated:	January 22, 2009

Additional relevant MeSH terms:


Migraine Disorders Headache Disorders, Primary Headache Disorders	Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on July 18, 2017

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