BIOMIGA: Results from Magnetic Resonance Imaging

NCT06633484 | Active Not Recruiting

• 1 other identifier: BIOMIGA-MR
• Study Type: observational
• Target: 219
• Locations: 3 countries
• Sites: 3

Brief 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).

Conditions

Migraine

Keywords

brain morphology; neuronal functional connectivity; CGRP-Antibodies

Outcome Measures

Primary Outcomes (3)

• resting state fMRI

  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.

  1 year

• Morphological MR

  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.

  1 year

• Arterial Spin Labelling MR

  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.

  1 year

Secondary Outcomes (3)

• resting-state fMRI

  1 year

• Morphological MRI, resting-state fMRI and arterial spin labelling MRI

  1 year

• Morphological MRI, resting-state fMRI and arterial spin labelling MRI

  1 year

Study Arms (2)

Migraine patients

Other: functional magnetic resonance imaging

Healthy Controls

Other: functional magnetic resonance imaging

Interventions

functional magnetic resonance imaging OTHER

non-diagnostic, non-invasive, passive measurement of the brain\'s structure and function

Healthy Controls; Migraine patients

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Migraine patients and Healthy controls. The healthy controls where recruited among hospital staff and non-related acquaintances of the patients. All migraine patients enrolled in the study have been treated with CGRP-targeting mABs according to the indications approved by the respective National regulatory bodies(Germany, Spain, Italy).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (3)

University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

IRCCS Mondino Foundation

Pavia, Italy

Location

Vall d'Hebron Institute of Research

Barcelona, Spain

Location

Related Publications (2)

• Hougaard A, Gaist D, Garde E, Iversen P, Madsen CG, Kyvik KO, Ashina M, Siebner HR, Madsen KH. Lack of reproducibility of resting-state functional MRI findings in migraine with aura. Cephalalgia. 2023 Nov;43(11):3331024231212574. doi: 10.1177/03331024231212574.

  PMID: 37950678 BACKGROUND

• Schönthaler, M.G.F., Basedau, H., May, A., Mehnert, J., 2024. Connectivity within the visual cortex predicts the efficacy of CGRP antibodies in migraine patients. DGKN 2024, Frankfurt, Germany and Clinical Neurophysiology 159, e22

  BACKGROUND

Related Links

• SPM12: Toolbox for preprocessing of (f)MRI data
• CONN: Toolbox for analysis of resting-state fMRI data
• CAT12: Toolbox for analysis of structural MRI data (MPRAGE/T1)
• ASLtbx: Toolbox for analysis of aterial-spin-labellingMRI data

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: October 9, 2024
• Study Start: January 15, 2021
• Primary Completion: March 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); ES (1); DE (1)