Neurophysiology of Prophylactic Treatment in Migraine

Migraine Clinical Trial

Official title:

Neurophysiological Characterization of Treatment Response Following the Initiation of Prophylactic Therapy in Episodic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019496
• Other study ID #: BB168/18
• Status: Completed
• Start date: January 29, 2019
• Est. completion date: May 2, 2021

Study information

• Verified date: May 2021
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2, 2021
• Est. primary completion date: May 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• antibodies 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

Locations

Country	Name	City	State
Germany	Department of Neurology	Greifswald	Mecklenburg-Vorpommern

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	transcranial magnetic stimulation (TMS)	input-output curves of motor evoked potential following single and double-pulse navigated TMS to the side stimulated during the nociceptive blink reflex examination	baseline and after 3 months
Other	electroencephalography (EEG)	EEG connectivity following nociceptive and sensory stimulation	baseline and after 3 months
Other	structural magnetic resonance imaging (sMRI)	volumetry of brain structures involved in central pain processing (e.g. cingulate cortex, insula, thalamus)	baseline and after 3 months
Other	functional magnetic resonance imaging (fMRI)	resting-state connectivity of networks involved in central pain processing	baseline and after 3 months
Primary	nociceptive blink reflex habituation	habituation of the area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches	baseline and after 3 months
Secondary	nociceptive blink reflex area	area under of the curve of the R2 blink reflex component on the side primarily affected by migraine headaches	baseline and after 3 months
Secondary	somatosensory evoked potentials (SSEP)	habituation of the N20 SSEP component following bilateral median nerve stimulation	baseline and after 3 months
Secondary	pattern-reversal visual evoked potentials (VEP)	habituation of the P100 VEP component following bilateral optic nerve stimulation	baseline and after 3 months
Secondary	migraine headache frequency	days with migraine headaches during the last month	baseline and after 3 months
Secondary	headache impact test (HIT-6)	impact of migraine severity on daily routine	baseline and after 3 months
Secondary	migraine disability assessment (MIDAS)	impact of migraine frequency on daily routine	baseline and after 3 months
Secondary	Patient-Reported Outcomes Measurement Information System Profile 29 (PROMIS-29)	multi domain patient reported quality of life	baseline and after 3 months