Does Topiramate Adjust the Excitability of the Brain in Migraine Sufferers?
Recruitment status was Not yet recruiting
|First Received Date ICMJE||February 2, 2006|
|Last Updated Date||February 13, 2006|
|Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00286923 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Does Topiramate Adjust the Excitability of the Brain in Migraine Sufferers?|
|Official Title ICMJE||Modulation of the Excitability of the Occipital Cerebral Cortex Using Topiramate|
The purpose of the study is to determine by the use of non-invasive magnetic stimulation if the medication Topiramate adjusts the excitability of the migraine sufferer's brain.
Previous studies have shown the migraine sufferer's brain is more excitable. The magnetic stimulation device has given us a way to look at excitability and to see if it changes at the same time that a headache diary shows if the pattern or severity of headaches changes with the administration of the drug Topiramate.
It is expected that as migraine sufferers have fewer headaches with topiramate the testing with magnetic stimulation will show that their brains are less excitable and that if the topiramate does not change the character of headaches then the pattern of excitabilty would not change from the baseline test before medication is started.
We propose a clinic-based study to test the hypothesis that topiramate modulates the excitability of the occipital cortex in migraine. Subjects between 18 and 55 years old, who have migraine with aura according to IHS criteria will be recruited from the headache clinic. All eligible subjects will have occipital cortex stimulation using the Magstim 200 apparatus. Magnetic brain stimulation will be performed using the 95 mm round coil of the Magstim 200 stimulator. All subjects will be provided ear plugs to prevent possible noise damage to the ear. The recordings will be conducted in a semi-darkened room. Subjects will be asked to focus on the center of a dark screen. A 95 mm diameter circular coil will be applied to the occipital scalp in the midline, 7 cm anterior to the inion. Stimulator intensity will be increased in 10% increments until the subjects report seeing phosphenes (bright scintillating scotomata in the subjects visual field generated by occipital cortical stimulation) or until a maximum of 100% intensity is reached. generated by occipital cortical stimulation) or until a maximum of 100% intensity is reached. Stimulation intensity will be fine tuned to determine the threshold at which phosphenes can be barely seen. In those subjects who do not report seeing phosphenes till 100% intensity, the stimulator will be moved in 1 cm steps to try to define an optimum point for stimulation. No more than 20 stimulations will be given and the frequency shall be kept to less than 5/min. The threshold at which phosphenes are generated will be recorded. To assess inhibitory function of the occipital cortex a visual suppression method will be utilized. Timed TMS impulses usually 10% above phosphene threshold or where suppression is noted will be delivered. Subjects will be asked to report letters projected at a fixed luminance on the screen. Visual suppression will be calculated based on the number of errors the subjects make using an automated analysis. The study procedure will be repeated after the patients have taken topiramate at gradually increasing doses and have achieved stable dose for one month. Patients will be placed on 25 mg at night for 1 week, increased to 25 mg B.I.D. for one week and then maintained at 50 mg B.I.D.
d. There will be no placebo in the study. e. Topiramate will be used in the study.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Drug: Topiramate|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Completion Date||August 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Subjects 18 to 55 years old with migraine headaches as defined by the International Headache Society (IHS).
Subjects must be willing to take topiramate for migraine prophylaxis
1. Subjects with frequent tension headaches 2. Subjects with ill-defined head pain 3. Unable to be weaned off other headache prophylaxis. 4. Requiring daily use of centrally-acting medications. 5. Pregnant, lactating and women not on adequate birth control measures. 6. Subjects with a personal or family history of seizures of any type. 7. History of head injury or brain surgery. 8. Cardiac pacemakers or any other implanted electronic device. 9. Subjects with history of headaches or with history of tension-type headaches recurring >1/month and relieved by over the counter medications.
|Ages||18 Years to 55 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00286923|
|Other Study ID Numbers ICMJE||CAPSS 347|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Emerald City Headache Organization|
|Collaborators ICMJE||Ortho-McNeil Neurologics, Inc.|
|Information Provided By||Emerald City Headache Organization|
|Verification Date||February 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP