functional magnetic resonance imaging: non-diagnostic, non-invasive, passive measurement of the brain\'s structure and function
Study summary
The projects comprising in the multicenter BIOMIGA project have been preregistered earlier with ID NTC04503083 at clinicaltrials.gov. Here the imaging subproject within the overall BIOMIGA aims is specified. The hypotheses for this subproject of the magnetic resonance imaging part is based on hypotheses generating analyses of the data from one site (Hamburg, Germany) of this three-center study. At all three sites healthy controls and migraine patients underwent identical protocols with 3 types of magnetic resonance imaging including structural scans (MPRAGE), resting-state functional magnetic resonance imaging (rs-fMRI) as well as arterial spin labeling (ASL) with matched protocols across sites. Data was acquired before CGRP-antibody administration (day 1) and 12 weeks afterwards (day 2). We analyzed the data from one site (Hamburg, Germany) as hypotheses generating, published these data as a poster and aim to validate our results with the not-yet analyzed data from the two other sites (Pavia, Italy and Barcelona, Spain).
Eligibility
Sex
ALL
Min age
25 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria:
Migraine patients
* Adults between 25 and 55 years of age of both sexes;
* Patients diagnosed with high-frequency migraine (HFM) 8 or more migraine days/month) or CM with or without aura (\>15 headache days migraine/month, of which 8 have migraine characteristics) according to the International Classification of Headache Disorders, 3rd edition, (ICHD-3);
* Females had to be postmenopausal for at least one year, surgically sterile or otherwise incapable of pregnancy, or using an acceptable method of birth control.
Healthy controls
* Adults between 25 and 55 years of age of both sex;
* Absence of any past, or first-degree familial history of recurrent primary or secondary headache disorders.
Exclusion Criteria:
For the clinical population:
* Headache on more than 25 days/month in the last 3 months;
* Medication overuse according to the ICHD-3 criteria.
For the entire study population (migraine and healthy controls)
* Presence of any other significant medical condition (neurological disorders, severe psychiatric illness or cardiovascular disease);
* Evidence of drug, smoking or alcohol abuse or dependence within 12 months prior to V1, based on medical records or patient self-report. An alcohol consumption \>100g/week will be considered as an abuse;
* Pregnant or breastfeeding women;
* Women of childbearing potential, defined as all women physiologically capable of becoming pregnant who are not on contraception;
* Concomitant use of other migraine preventive drugs that may interfere with the endpoints of the study.
Primary outcome measure(s)
resting state fMRI — 1 year Prediction of reduction in number of headache days at day 1. The statistical threshold will will be set to a small-volume corrected p\<0.05 in the combined data from Barcelona and Pavia.
Morphological MR — 1 year Prediction of reduction in number of headache days by gray and white matter density at day 1. The statistical threshold for the data of the two other sites will be set to voxel-wise FWE-corrected p\<0.05.
Arterial Spin Labelling MR — 1 year Prediction of reduction in number of headache days by brain perfusion at day 1. ASL was not yet analyzed for any of the sites. For the statistics we will use Cerebral Perfusion Images stemming from the toolbox ASLtbx (https://www.cfn.upenn.edu/zewang/ASLtbx\_manual.pdf). The statistical threshold will be set to voxel-wise FWE-corrected p\<0.05.
Trial sites (3)
Facility
City
Region
Status
University Medical Center Hamburg-Eppendorf
Hamburg
Germany
IRCCS Mondino Foundation
Pavia
Italy
Vall d'Hebron Institute of Research
Barcelona
Spain
More Universitätsklinikum Hamburg-Eppendorf trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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