Research Study Examining Nerve Block for Migraine

Migraine Clinical Trial

Official title:

Greater Occipital Nerve (GON) Block for Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203346
• Other study ID #: WBY/GON
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 22, 2009
• Start date: June 2005

Study information

• Verified date: January 2009
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Procedure:
• Greater Occipital Nerve Block

Locations

Country	Name	City	State
United States	Jefferson Headache Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States,