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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Episodic Migraine |
| ||
| Healthy controls | equal to or less than 1 headache day/month |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antibodies against calcitonin-gene related peptide or its receptor | Drug | 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 |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| transcranial magnetic stimulation (TMS) | input-output curves of motor evoked potential following single and double-pulse navigated TMS to the side stimulated during the nociceptive blink reflex examination | baseline and after 3 months |
| electroencephalography (EEG) |
Inclusion Criteria (migraineurs):
Exclusion Criteria (migraineurs):
Inclusion criteria (controls):
exclusion criteria (controls):
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All patients seen in the local headache clinic are screened for eligibility to participate the study. Clinical routine is not influenced by participation in this observational study, importantly choice of prophylactic treatment solely depends on the physician's and patient's decision based on national guidelines.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34895133 | Derived | Thiele A, Klehr L, Strauss S, Angermaier A, Schminke U, Kronenbuerger M, Naegel S, Fleischmann R. Preventive treatment with CGRP monoclonal antibodies restores brain stem habituation deficits and excitability to painful stimuli in migraine: results from a prospective case-control study. J Headache Pain. 2021 Dec 11;22(1):149. doi: 10.1186/s10194-021-01364-x. |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
EEG connectivity following nociceptive and sensory stimulation |
| baseline and after 3 months |
| structural magnetic resonance imaging (sMRI) | volumetry of brain structures involved in central pain processing (e.g. cingulate cortex, insula, thalamus) | baseline and after 3 months |
| functional magnetic resonance imaging (fMRI) | resting-state connectivity of networks involved in central pain processing | baseline and after 3 months |
| D009422 | Nervous System Diseases |