Neurophysiology of Prophylactic Treatment in Migraine
- Conditions
- Migraine
- Interventions
- Drug: antibodies against calcitonin-gene related peptide or its receptor
- Registration Number
- NCT04019496
- Lead Sponsor
- University Medicine Greifswald
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 44
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Episodic Migraine antibodies against calcitonin-gene related peptide or its receptor -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
Trial Locations
- Locations (1)
Department of Neurology
🇩🇪Greifswald, Mecklenburg-Vorpommern, Germany