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

NCT05524493 | Recruiting

• 1 other identifier: 2022-00936
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (14)

• 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

  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)

• HADS questionnaire (Hospital anxiety and depression scale)

  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)

Study Arms (4)

Healthy participants

Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy

Patients with migraine

Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy

Patients with drug resistent epilepsy

Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy

Patients with visual snow syndrome

Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy

Interventions

Structural MRI 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

Healthy participants; Patients with drug resistent epilepsy; Patients with migraine; Patients with visual snow syndrome

Quantitative MRI 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).

Healthy participants; Patients with drug resistent epilepsy; Patients with migraine; Patients with visual snow syndrome

Diffusion MRI DIAGNOSTIC_TEST

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

Healthy participants; Patients with drug resistent epilepsy; Patients with migraine; Patients with visual snow syndrome

fMRI 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.

Healthy participants; Patients with drug resistent epilepsy; Patients with migraine; Patients with visual snow syndrome

MR Spectroscopy DIAGNOSTIC_TEST

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

Healthy participants; Patients with drug resistent epilepsy; Patients with migraine; Patients with visual snow syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Zurich: lead
• Balgrist University Hospital: collaborator

Study Sites (2)

Klinik Lengg

Zurich, 8008, Switzerland

RECRUITING

University Hospital Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Epilepsy; visual snow syndrome

Interventions

Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

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

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynn Farner, MSc

CONTACT

+41 44 510 72 08; lynn.farner@balgrist.ch

Study Design

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

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: September 1, 2022
• Study Start: March 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Locations

CH (2)