Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
Overview
- Phase
- Not Applicable
- Intervention
- antibodies against calcitonin-gene related peptide or its receptor
- Conditions
- Migraine
- Sponsor
- University Medicine Greifswald
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- nociceptive blink reflex habituation
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Episodic Migraine
Intervention: antibodies against calcitonin-gene related peptide or its receptor
Outcomes
Primary Outcomes
nociceptive blink reflex habituation
Time Frame: 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 Outcomes
- nociceptive blink reflex area(baseline and after 3 months)
- somatosensory evoked potentials (SSEP)(baseline and after 3 months)
- pattern-reversal visual evoked potentials (VEP)(baseline and after 3 months)
- migraine headache frequency(baseline and after 3 months)
- headache impact test (HIT-6)(baseline and after 3 months)
- migraine disability assessment (MIDAS)(baseline and after 3 months)
- Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)(baseline and after 3 months)