High-field MR Imaging in Migraine, Visual Snow and Epilepsy

NCT ID: NCT05524493

Last Updated: 2025-10-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-06-30

Brief Summary

In this project, the aim is to recruit patients with drug resistant epilepsy and those suffering from migraine. Interestingly, patients suffering from epilepsy are also more often reporting to suffer from migraine. The pathobiology is understudied, but it is believed that both etiologies results from brain networks changes. A clinical certified 7T Terra Siemens scanner will be employed to assess in all participants (including healthy controls) how the microstructure differs in disease specific areas. Patients will further be clinically assessed as well as undergo questionnaires.

Migraine is also a common comorbidity to visual snow syndrom and has been shown to impact similar brain regions. However, the pathophysiology is still understudied and a better understanding of the two diseases is needed.

Conditions

Migraine; Epilepsy; Visual Snow Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy participants

Structural MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using conventional structural MRI in the brain and spinal cord including T1-, T2-, and T2\*-weighted sequences

Quantitative MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using quantitative MRI in the brain and spinal cord. This includes multi-parameter mapping (MPM) and quantitative susceptibility mapping (QSM).

Diffusion MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

fMRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using resting-state and task fMRI (including sensory stimulation using pain stimulus) in both brain and spinal cord.

MR Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Patients with migraine

Structural MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using conventional structural MRI in the brain and spinal cord including T1-, T2-, and T2\*-weighted sequences

Quantitative MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using quantitative MRI in the brain and spinal cord. This includes multi-parameter mapping (MPM) and quantitative susceptibility mapping (QSM).

Diffusion MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

fMRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using resting-state and task fMRI (including sensory stimulation using pain stimulus) in both brain and spinal cord.

MR Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Patients with drug resistent epilepsy

Structural MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using conventional structural MRI in the brain and spinal cord including T1-, T2-, and T2\*-weighted sequences

Quantitative MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using quantitative MRI in the brain and spinal cord. This includes multi-parameter mapping (MPM) and quantitative susceptibility mapping (QSM).

Diffusion MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

fMRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using resting-state and task fMRI (including sensory stimulation using pain stimulus) in both brain and spinal cord.

MR Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Patients with visual snow syndrome

Structural MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using conventional structural MRI in the brain and spinal cord including T1-, T2-, and T2\*-weighted sequences

Quantitative MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using quantitative MRI in the brain and spinal cord. This includes multi-parameter mapping (MPM) and quantitative susceptibility mapping (QSM).

Diffusion MRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

fMRI

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using resting-state and task fMRI (including sensory stimulation using pain stimulus) in both brain and spinal cord.

MR Spectroscopy

Intervention Type: DIAGNOSTIC_TEST

We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Interventions

Structural MRI

We will examine migraine and epilepsy patients as well as healthy controls using conventional structural MRI in the brain and spinal cord including T1-, T2-, and T2\*-weighted sequences

Intervention Type: DIAGNOSTIC_TEST

Quantitative MRI

We will examine migraine and epilepsy patients as well as healthy controls using quantitative MRI in the brain and spinal cord. This includes multi-parameter mapping (MPM) and quantitative susceptibility mapping (QSM).

Intervention Type: DIAGNOSTIC_TEST

Diffusion MRI

We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

Intervention Type: DIAGNOSTIC_TEST

fMRI

We will examine migraine and epilepsy patients as well as healthy controls using resting-state and task fMRI (including sensory stimulation using pain stimulus) in both brain and spinal cord.

Intervention Type: DIAGNOSTIC_TEST

MR Spectroscopy

We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

Patients:

• Patient must be able to read and sign the informed consent form
• Stable prophylactic medication for 2 months prior to MRI
• At leat one of the two criteria applies:
• Patients diagnosed with migraine (with or without aura, episodic or chronic). Diagnosis is ensured by clinical interview (at least 8 weeks prior to MRI). Also, patients complete a migraine questionnaire (HARDSHIP) (at least 8 weeks before MRI). Migraine frequency ≥ 2 migraine attacks/month.
• Patients with drug resistent epilepsy accroding to ILAE crtieria
• Patients with diagnoses of Visual snow syndrome

Healthy participants;

• No migraine (validated by questionnaire) or epilepsy
• Participants must be able to read and sign the informed consent form

Exclusion Criteria

• Treatment of migraine disease with Botox within < 4 months before baseline and during the study period
• Pregnant or breastfeeding women
• Intention during the course of the trial to become pregnant
• Women with bilateral ovariectomy, with or without hysterectomy, and postmenopausal women (>2 years of age) are not considered childbearing.
• Other clinically significant comorbidities (e.g., renal insufficiency, hepatic dysfunction, cardiovascular disease, etc.),
• Known or suspected noncompliance with the protocol, drug or alcohol abuse,
• Patient's inability to follow trial procedures, e.g., due to language problems, mental illness, dementia, etc.,
• Prior participation in the clinical trial
• Enrolment of the investigator, his/ her family members, employees and other dependent persons of the test personnel
• Metallic objects in the body (e.g., splinters, MR incompatible implants).
• Pacemaker
• Claustrophobia
• Obesity (body mass index > 35 kg/m2)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Balgrist University Hospital

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Freund, Prof. Dr. med. Dr. rer. nat.

Role: PRINCIPAL_INVESTIGATOR

University of Zurich

Locations

Klinik Lengg

Zurich, , Switzerland

Site Status: RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Lynn Farner, MSc

Role: CONTACT

lynn.farner@balgrist.ch

+41 44 510 72 08

Facility Contacts

Lukas Imbach, PD Dr. med.

Role: primary

lukas.imbach@kliniklengg.ch

+41 44 387 63 02

Lars Michels, PD Dr.

Role: primary

lars.michels@usz.ch

+41 44 255 49 65

Heiko Pohl, Dr. med.

Role: backup

heiko.pohl@usz.ch

+41 44 255 55 11

Other Identifiers

2022-00936

Identifier Type: -

Identifier Source: org_study_id