(Botox) Mechanisms of Action in Altering the Molecular Environment in Which Pain Fibers Exist

Study Overview
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Brief Summary
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To compare Botox-treated and Botox-untreated symptomatic tissues (defined as areas where the head hurts and the pain is felt) of chronic migraine (CM) patients using molecular studies.

Detailed Description
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Eligible patients for migraine surgery will be injected unilaterally with Botox prior to surgery. The effects of Botox on tissues will be evaluated.

Official Title
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Novel Concepts for OnabotulinumtoxinA (Botox) Mechanisms of Action: Role in Altering the Molecular Environment in Which Pain Fibers Exist

Conditions
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Migraine

Intervention / Treatment
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* Drug: Botulinum toxin type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 years Diagnosis of Chronic Migraine consistent with International Classification of Headache Disorders (ICHD-III) criteria, with a history of bilateral headache pain and chronic tenderness in neck muscles Patient is capable and willing to provide informed consent Female subjects of child bearing potential must have a negative pregnancy test at enrollment and agree to remain abstinent or use acceptable methods of birth control (i.e., hormonal contraceptives, inrauterine device, diaphragm with spermicide, cervical cap or sponge, condoms or partner has had a vasectomy) for three months following injections of Botox Patients referred by their primary Neurologist to the study surgeon and who are determined to be candidates for surgical decompression of extracranial sensory nerves. Patient agrees to abstain from protocol-specific excluded medications beginning 14 days prior to the decompression surgery. Exclusion Criteria: Patient has hypersensitivity reactions or other intolerance to Botox Patient is pregnant or trying to become pregnant with the timeframe of the study. Infection at proposed injection sites.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin type A injection arm<br>All patients will be injected with Botulinum toxin on one side of the back of the head. | Drug: Botulinum toxin type A<br>* Injection of Botulinum toxin type A in back of head<br>* Other names: Botox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molecular markers in discarded tissue of migraine patients | molecular markers in discarded tissue of migraine surgery will be analyzed. Gene Expression CodeSet profiling 594 genes; 579 immunology-related human genes + 15 internal reference controls. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic migraine, trigeminal neuralgia, migraine surgery, nerve decompression