Research Study Examining Nerve Block for Migraine

NCT ID: NCT00203346

Last Updated: 2009-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Greater Occipital Nerve Block

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Principal Investigators

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William B Young, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University, Jefferson Headache Center

Locations

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Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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WBY/GON

Identifier Type: -

Identifier Source: org_study_id

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