Clinical trial NCT04019496: Neurophysiology of Prophylactic Treatment in Migraine
Official title: Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: blink reflex
electroencephalography
functional magnetic resonance imaging
evoked potentials
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: nociceptive blink reflex habituation
timeFrame: baseline and after 3 months
Secondary outcomes:
measure: nociceptive blink reflex area
timeFrame: baseline and after 3 months
measure: somatosensory evoked potentials (SSEP)
timeFrame: baseline and after 3 months
measure: pattern-reversal visual evoked potentials (VEP)
timeFrame: baseline and after 3 months
measure: migraine headache frequency
timeFrame: baseline and after 3 months
measure: headache impact test (HIT-6)
timeFrame: baseline and after 3 months
measure: migraine disability assessment (MIDAS)
timeFrame: baseline and after 3 months
measure: Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)
timeFrame: baseline and after 3 months
Other outcomes:
measure: transcranial magnetic stimulation (TMS)
timeFrame: baseline and after 3 months
measure: electroencephalography (EEG)
timeFrame: baseline and after 3 months
measure: structural magnetic resonance imaging (sMRI)
timeFrame: baseline and after 3 months
measure: functional magnetic resonance imaging (fMRI)
timeFrame: baseline and after 3 months
Locations:
city: Greifswald
country: Germany
facility: Department of Neurology
state: Mecklenburg-Vorpommern
Study officials:
References:
citation: 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.