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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Migraine; Visual Snow Syndrome
• Intervention / Treatment: Diagnostic test: Structural MRI; Diagnostic test: Quantitative MRI; Diagnostic test: Diffusion MRI; Diagnostic test: fMRI; Diagnostic test: MR Spectroscopy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lynn Farner, MSc; Phone Number: +41 44 510 72 08; Email: lynn.farner@balgrist.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Lars Michels, PD Dr.; Phone Number: +41 44 255 49 65; Email: lars.michels@usz.ch
    • Contact: Heiko Pohl, Dr. med.; Phone Number: +41 44 255 55 11; Email: heiko.pohl@usz.ch
  • Zurich, Switzerland, 8008
    • Recruiting
    • Klinik Lengg
    • Contact: Lukas Imbach, PD Dr. med.; Phone Number: +41 44 387 63 02; Email: lukas.imbach@kliniklengg.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from the primary care clinics as well as from referring physicians or other clinics.

Healthy controls will be recruited via public announcements and via flyers distributed at a primary care clinic and two universities.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy participants	Diagnostic test: 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; 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).; 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.; 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.; 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.
Patients with migraine	Diagnostic test: 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; 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).; 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.; 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.; 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.
Patients with drug resistent epilepsy	Diagnostic test: 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; 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).; 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.; 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.; 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.
Patients with visual snow syndrome	Diagnostic test: 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; 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).; 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.; 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MR: multi-parameter mapping (MPM)	Once during visit 2 (1-2 weeks after visit 1)
MR: quantitative susceptibility mapping (QSM)	Once during visit 2 (1-2 weeks after visit 1)
Resting-state fMRI (brain and brainstem/spinal cord)	Once during visit 2 (1-2 weeks after visit 1)
MR: whole-brain structural scans	Once during visit 2 (1-2 weeks after visit 1)
MR: routine clinical scans	Once during visit 2 (1-2 weeks after visit 1)
MR spectrosocpy	Once during visit 2 (1-2 weeks after visit 1)
MR: diffusion imaging	Once during visit 2 (1-2 weeks after visit 1)
MR: axial T2*w sequence	Once during visit 2 (1-2 weeks after visit 1)
Task-fMRI	Once during visit 2 (1-2 weeks after visit 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraine patients: number of migraine attacks, intensity of migraine attacks (intensity 0 - 10), duration, accompanying symptoms, Migraine diary		Once during visit 1 (1-2 weeks prior to visit 2)
Migraine patients: Headache-attributed restriction, disability, social handicap and impaired participation (HARDSHIP) questionnaire	Modified questionnaire including personal and socio-demographic, diagnostic questions related to migraine, and enquiry into headache-related burden without strict scale	Once during visit 1 (1-2 weeks prior to visit 2)
HADS questionnaire (Hospital anxiety and depression scale)	0-42, higher score > higher probability of anxiety/ depression	Once during visit 1 (1-2 weeks prior to visit 2) for patients and once for healthy participants at MRI visit (1-2 weeks after inclusion into study)
Acute medication		Once during visit 1 for patients (1-2 weeks prior to visit 2) and once for healthy participants at MRI visit (1-2 weeks after inclusion into study)
Epilepsy patients: diagnosis and classification according to ILAE		Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: current anticonvulsant medication		Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: seizure frequency		Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: analysis of previous EEG examinations with determination of the epileptic focus (hemisphere, localization)		Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: analysis of previous EEG examinations with qualitative assessment of the EEG to determine the type of epilepsy-specific abnormalities		Once during visit 1 (1-2 weeks prior to visit 2)
Migraine patients: documentation of previous therapy attempts	Which type of therapy (medication, behavioral therapy or neuromodulation)	Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: documentation previous therapy attempts	Which type of therapy (medication, surgical intervention or neurostimulation)	Once during visit 1 (1-2 weeks prior to visit 2)
Migraine/ epilepsy/ visual snow syndrome patients: recording of possible other headache disorders and medication overuse		Once during visit 1 (1-2 weeks prior to visit 2)
Visual snow syndrome: Puledda Questionnaire	The higher the score, the higher the impact of visual snow	Once during visit 2 (1-2 weeks after visit 1)
Migraine: Dizziness Handicap Inventory (DHI)	Score from 0-100, the higher the score, the higher the vertigo impact	Once during visit 2 (1-2 weeks after visit 1)

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Balgrist University Hospital
• Investigators: Principal Investigator: Patrick Freund, Prof. Dr. med. Dr. rer. nat., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 8, 2025
• Last Update Submitted That Met QC Criteria: October 2, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Epilepsy; visual snow syndrome; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Magnetic Resonance Imaging; Diffusion Magnetic Resonance Imaging
• Other Study ID Numbers: 2022-00936

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No