Neurophysiology of Prophylactic Treatment in Migraine

Study Overview
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Brief Summary
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This study aims to improve the pathophysiological understanding of migraine in in a longitudinal observational study investigating changes of established neurophysiological and imaging parameters in line with changes of the clinical phenotype. The study's focus is the investigation of mechanisms that are directly related to the cyclic character of migraine and its core structures. In this context, the primary endpoint is a change in the nociceptive blink reflex, an established brain stem reflex to study the trigemino-spinal system, associated with changes in migraine frequency and severity. In order to reliably detect changes in the trigeminal pain system, investigations are performed in patients before starting a prophylactic therapy and 3 months afterwards. Several secondary endpoints are used to evaluate changes of multimodal sensory and cortical information processing. Cerebral imaging will include examinations of structural and network effects of altered migraine disease activity.

Official Title
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Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: antibodies against calcitonin-gene related peptide or its receptor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria (migraineurs): episodic migraine according to ICHD (international classification of headache disorders)-3 criteria headache documented over at least 3 months through a headache calender scheduled for prophylactic therapy of their migraine Exclusion Criteria (migraineurs): history of chronic migraine current medication-overuse headache neurological or psychiatric diagnosis other than headaches chronic intake of central nervous system active drugs (antidepressants, antipsychotics etc.) contraindications for magnetic resonance imaging contraindications for transcranial magnetic stimulation Inclusion criteria (controls): not more than 3 years younger or older than matched control gender similar to matched control menstrual cycle equal to matched control (if female) exclusion criteria (controls): more than 1 headache day/month history of migraine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Episodic Migraine<br> | Drug: antibodies against calcitonin-gene related peptide or its receptor<br>* the study is observational and does not interfere with clinical routine. In lin with this notion, the intervention is chosen by the treating physician in a shared decision making process involving the patient<br>|
| Healthy controls<br>equal to or less than 1 headache day/month | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nociceptive blink reflex habituation | habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches | baseline and after 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nociceptive blink reflex area | area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches | baseline and after 3 months | 
| somatosensory evoked potentials (SSEP) | habituation of the N20 SSEP component following bilateral median nerve stimulation | baseline and after 3 months | 
| pattern-reversal visual evoked potentials (VEP) | habituation of the P100 VEP component following bilateral optic nerve stimulation | baseline and after 3 months | 
| migraine headache frequency | days with migraine headaches during the last month | baseline and after 3 months | 
| headache impact test (HIT-6) | impact of migraine severity on daily routine | baseline and after 3 months | 
| migraine disability assessment (MIDAS) | impact of migraine frequency on daily routine | baseline and after 3 months | 
| Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29) | multi domain patient reported quality of life | baseline and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blink reflex, electroencephalography, functional magnetic resonance imaging, evoked potentials