Neurophysiology of Prophylactic Treatment in Migraine

University Medicine Greifswald

Status: Completed

Conditions: Migraine

Treatments: Drug: antibodies against calcitonin-gene related peptide or its receptor

Study type: Observational

Funder types: Other

Identifiers

NCT04019496

BB168/18

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

44 participants in 2 patient groups

Episodic Migraine

Treatment:

Drug: antibodies against calcitonin-gene related peptide or its receptor

Healthy controls

Description:

equal to or less than 1 headache day/month