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NCT Number: NCT05524493

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik Lengg, Zurich, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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).

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.

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.

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.

Primary outcomes

  1. MR: multi-parameter mapping (MPM)

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  2. MR: quantitative susceptibility mapping (QSM)

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  3. Resting-state fMRI (brain and brainstem/spinal cord)

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  4. MR: whole-brain structural scans

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  5. MR: routine clinical scans

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  6. MR spectrosocpy

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  7. MR: diffusion imaging

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  8. MR: axial T2*w sequence

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

  9. Task-fMRI

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

Secondary outcomes

  1. Migraine patients: number of migraine attacks, intensity of migraine attacks (intensity 0 - 10), duration, accompanying symptoms, Migraine diary

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  2. Migraine patients: Headache-attributed restriction, disability, social handicap and impaired participation (HARDSHIP) questionnaire

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

    Modified questionnaire including personal and socio-demographic, diagnostic questions related to migraine, and enquiry into headache-related burden without strict scale

  3. Migraine/ epilepsy/ visual snow syndrome patients: recording of possible other headache disorders and medication overuse

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  4. HADS questionnaire (Hospital anxiety and depression scale)

    Time frame: 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)

    0-42, higher score > higher probability of anxiety/ depression

  5. Acute medication

    Time frame: 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)

  6. Epilepsy patients: diagnosis and classification according to ILAE

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  7. Epilepsy patients: current anticonvulsant medication

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  8. Epilepsy patients: seizure frequency

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  9. Epilepsy patients: analysis of previous EEG examinations with determination of the epileptic focus (hemisphere, localization)

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  10. Epilepsy patients: analysis of previous EEG examinations with qualitative assessment of the EEG to determine the type of epilepsy-specific abnormalities

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

  11. Migraine patients: documentation of previous therapy attempts

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

    Which type of therapy (medication, behavioral therapy or neuromodulation)

  12. Epilepsy patients: documentation previous therapy attempts

    Time frame: Once during visit 1 (1-2 weeks prior to visit 2)

    Which type of therapy (medication, surgical intervention or neurostimulation)

  13. Visual snow syndrome: Puledda Questionnaire

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

    The higher the score, the higher the impact of visual snow

  14. Migraine: Dizziness Handicap Inventory (DHI)

    Time frame: Once during visit 2 (1-2 weeks after visit 1)

    Score from 0-100, the higher the score, the higher the vertigo impact

Study contacts

Contact information is provided by the study sponsor or research team.

Lynn Farner, MSc

CONTACT

[email protected]

+41 44 510 72 08

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Balgrist University Hospital

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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