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

Phase 4

Completed

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

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Botulinum toxin type A injection arm	Botulinum toxin type A	All patients will be injected with Botulinum toxin on one side of the back of the head.

Primary Outcome Measures

Name	Time	Method
Inflammatory Gene Expression in Chronic Migraine Patients With OnabotulinumtoxinA Injection Treatment Versus No Treatment	One year	In this split-person study, patients with chronic bilateral occipital migraines scheduled for a study-unrelated migraine surgery (occipital nerve decompression surgery) had one side of their head undergo treatment with onabotulinumtoxinA injection, while the other side of the head underwent no treatment. Occipital periosteum tissue of both injected and uninjected sides was collected during migraine surgery for targeted transcriptome profiling and genome-wide epigenome analyses of inflammatory gene expression using NanoString of 594 genes (579 immunology-related genes involved in adaptive/innate response, lymphocyte activation, cytokine/chemokine/NF-kB/TNF/interferon signalling, neutrophils, macrophages, cytotoxic T, NK, Th1, B and dendritic cells, and 15 internal reference controls). The effects size (ratio of geometric means) of expression of gene expression was evaluated between injected and uninjected sides.

Secondary Outcome Measures