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Trial record 27 of 36 for:    fmri headache

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02436499
Recruitment Status : Completed
First Posted : May 6, 2015
Last Update Posted : September 15, 2017
Dr. Behzad Mansouri (Co-Primary Investigator)
Information provided by (Responsible Party):
Dr. Dana Turcotte, University of Manitoba

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

Condition or disease Intervention/treatment Phase
Chronic Migraine Drug: Botulinum Toxin-A Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Chronic Migraine Treatment With Botulinum Toxin-A: an Investigation of Functional Magnetic Resonance Imaging Changes."
Study Start Date : July 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment with Botox and fMRI screening
Following baseline screening, participants will receive two subsequent treatments with botulinum-A toxin, each separated by 12 weeks. Participants will receive standardized botulinum-A toxin dosing for chronic migraine prophylaxis, comprised of 155 total units given at 31 specified sites across 7 head/neck muscles (protocol to be explicitly described in full protocol). Second dose of botulinum-A toxin will either be maintained at 155 total units as dosed initially, or be increased to 195 total units, depending on response to clinical questionnaires and examination to evaluate response and efficacy (to be described in full protocol, consistent with the "Follow-the-Pain Injection Paradigm").
Drug: Botulinum Toxin-A
Other Name: Botox

Primary Outcome Measures :
  1. function MRI imaging changes [ Time Frame: 140 days ]
    3 fMRI scans will be done - one prior to treatment and two subsequent scans at Day 56 and Day 140

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02436499

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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E0T5
Sponsors and Collaborators
University of Manitoba
Dr. Behzad Mansouri (Co-Primary Investigator)

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Responsible Party: Dr. Dana Turcotte, Assistant Professor, University of Manitoba Identifier: NCT02436499     History of Changes
Other Study ID Numbers: B2015:022
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents