Chronic Migraine Treatment With Botulinum Toxin-A: an Investigation of Functional Magnetic Resonance Imaging Changes.

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Pilot study evaluating effect of Botox injection treatment for 12 individuals suffering from chronic migraine on function MRI imaging, before and after treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manitoba
• Collaborator: Dr. Behzad Mansouri (Co-Primary Investigator)
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Female and male patients, 18-65 years of age with confirmed chronic migraine (defined as migraine headache with or without aura, occurring on > 15 days of each month for at least 3 months

• Headaches must have at least two of the following characteristics: unilateral location, pulsating quality, moderate-severe pain intensity and/or aggravation by or causing avoidance of routine physical activity (eg. Walking or climbing stairs)

• Headaches must also have at least one of: nausea and/or vomiting or photophobia and/or phonophobia.

• Patients must be cognitively able to understand questionnaires and be able to complete Headache Logs.

• Patients must be physically able to undergo treatment administration, including the required positional changes needed for administration.

Exclusion Criteria:

• Headaches that could be attributed to other causes, as determined by clinician, including medication overuse headaches and chronic tension type headache.

• Females of childbearing age with confirmed or suspected pregnancy, those planning on conceiving during the trial duration and women who are breastfeeding.

• Previous treatment with botulinum toxin-A for chronic migraine.

• Confirmed allergy to botulinum toxin-A or any of the product components.

• Contraindications to fMRI procedure.

• Patients unable to discontinue migraine prophylaxis medications, including tricyclic antidepressants, beta-blockers and various antiepileptic medications, either due to unwillingness or safety issues (eg. Antiepileptics being used to manage seizure disorder). This will be determined by clinician.

• Participants exhibiting severe depression (BDI score >40) and/or suicidal ideation. These individuals will receive appropriate medical follow-up for psychological management.

• Active skin infection at planned injection site(s).