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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04019496
Other study ID # BB168/18
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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