Migraine
Conditions
Keywords
blink reflex, electroencephalography, functional magnetic resonance imaging, evoked potentials
Brief summary
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.
Interventions
DRUGantibodies against calcitonin-gene related peptide or its receptor
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
Sponsors
University Medicine Greifswald
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| nociceptive blink reflex habituation | baseline and after 3 months | habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pattern-reversal visual evoked potentials (VEP) | baseline and after 3 months | habituation of the P100 VEP component following bilateral optic nerve stimulation |
| migraine headache frequency | baseline and after 3 months | days with migraine headaches during the last month |
| headache impact test (HIT-6) | baseline and after 3 months | impact of migraine severity on daily routine |
| migraine disability assessment (MIDAS) | baseline and after 3 months | impact of migraine frequency on daily routine |
| Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29) | baseline and after 3 months | multi domain patient reported quality of life |
| nociceptive blink reflex area | baseline and after 3 months | area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches |
| somatosensory evoked potentials (SSEP) | baseline and after 3 months | habituation of the N20 SSEP component following bilateral median nerve stimulation |
Other
| Measure | Time frame | Description |
|---|---|---|
| structural magnetic resonance imaging (sMRI) | baseline and after 3 months | volumetry of brain structures involved in central pain processing (e.g. cingulate cortex, insula, thalamus) |
| functional magnetic resonance imaging (fMRI) | baseline and after 3 months | resting-state connectivity of networks involved in central pain processing |
| transcranial magnetic stimulation (TMS) | baseline and after 3 months | input-output curves of motor evoked potential following single and double-pulse navigated TMS to the side stimulated during the nociceptive blink reflex examination |
| electroencephalography (EEG) | baseline and after 3 months | EEG connectivity following nociceptive and sensory stimulation |
Countries
Germany
Outcome results
None listed