Active not recruitingOBSERVATIONAL

BIOMIGA: Results From Magnetic Resonance Imaging

This study, called BIOMIGA, is using special brain scans called MRI to learn more about migraine. Doctors want to understand how migraine affects the brain and how it responds to treatment. They are scanning people with migraine and healthy volunteers to compare their brains. The scans are done before migraine treatment and again 12 weeks later. This helps researchers see how the brain changes and if these changes are linked to fewer headache days. The study has already looked at some results from Germany and plans to confirm these findings with data from Italy and Spain.

At a glance

Status

Active not recruiting

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

219

Start

15 Jan 2021

Estimated completion

01 Dec 2026

Migraine

What is this study about?

Imagine being able to look inside the brain to see how migraine works and how it changes with treatment. That's exactly what the BIOMIGA study is trying to do using a special type of brain scan called Magnetic Resonance Imaging (MRI). MRI is a safe way to get very detailed pictures of the brain without using X-rays.

Researchers are using different types of MRI scans. Some scans look at the brain's structure, while others measure blood flow and activity. By comparing these scans in people with migraine and healthy volunteers, they hope to find specific patterns or differences that can tell us more about migraine. Importantly, they are also scanning migraine patients before they start a new type of migraine treatment and again 12 weeks later. This allows them to see if and how the brain changes after treatment, and if these changes are linked to people having fewer migraine days.

The early results from one part of the study in Germany have given researchers some ideas about what they might find. Now, they are carefully checking these ideas by looking at brain scan data from other participants in Italy and Spain. This helps them make sure their findings are reliable and apply to more people. Ultimately, the goal is to better understand migraine and potentially find new ways to help those who suffer from it.

Key takeaways

Uses brain scans (MRI) to study migraine.
Compares brain changes before and after migraine treatment.
Includes people with frequent migraines and healthy volunteers.
Aims to understand how migraine affects the brain.
Findings could help develop future migraine treatments.

Who may be eligible?

To be considered for this study, you need to be an adult between 25 and 55 years old. If you have migraine, you must experience migraines frequently, meaning 8 or more migraine days per month, or chronic migraine with 15 or more headache days per month (where at least 8 are migraine days). Women who could become pregnant need to be using reliable birth control, be past menopause, or be unable to get pregnant for other reasons.

If you don't have migraine, you could be a healthy volunteer. This means you should not have ever had regular headaches or a family history of headaches. For everyone in the study, there are certain health conditions that would prevent you from taking part, such as other serious medical problems, having had a headache on more than 25 days a month in the last three months, or issues with substance abuse. You also can't be pregnant or breastfeeding, or taking other migraine prevention medicines that might affect the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 25-55 years old?
Do you have frequent or chronic migraines (8+ migraine days or 15+ headache days/month)?
Are you able to safely have an MRI scan?
Are you free from other serious medical, neurological, or psychiatric conditions?
Are you not pregnant or breastfeeding, and for women, using reliable birth control if applicable?

Answer every question to see your result.

What does participation involve?

This study involves undergoing brain scans (MRI) on two separate occasions. The first set of scans will happen before you start a specific migraine treatment (if you are a migraine patient), and the second set will be done 12 weeks later. Each MRI session will involve different types of scans that look at your brain's structure, activity, and blood flow. You will undergo the same scanning process at both appointments. The researchers will then compare your scans between the two time points and with scans from healthy volunteers to see how your brain changes and if these changes are related to how well your migraine treatment works.

Potential risks and benefits

Taking part in this study could help doctors better understand migraine and develop new ways to help people with this condition in the future. While there's no direct benefit to you from the scans themselves, the information gained is valuable for research. The MRI scans are generally safe and don't use radiation, but some people might find the scanner noisy or feel a bit claustrophobic inside. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

University Medical Center Hamburg-Eppendorf
Verified postcode
Hamburg, Germany
IRCCS Mondino Foundation
Verified postcode
Pavia, Italy
Vall d'Hebron Institute of Research
Verified postcode
Barcelona, Spain

Common questions

What is an MRI scan?

An MRI scan uses strong magnets and radio waves to create detailed pictures of the inside of your body, including your brain. It does not use X-rays.

Will I receive any treatment as part of this study?

This study looks at brain changes before and after you receive a CGRP-antibody treatment, but the treatment itself is not provided by the study. You would receive this treatment as part of your usual care.

How long will each visit take?

The study does not specify the exact length of each visit, but MRI scans can take some time. You would need to ask the study team for more details on visit duration.

What does 'healthy controls' mean?

'Healthy controls' are volunteers who do not have migraine or a history of regular headaches. They help researchers compare brain patterns with those who have migraine.

Will this study cure my migraines?

This study is for research purposes to understand migraine better. It is not designed to directly cure your migraines, but the findings could help develop better treatments in the future.