RecruitingNCT05524493

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


Sponsor

University of Zurich

Enrollment

200 participants

Start Date

Mar 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria10

  • 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 Criteria13

  • 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)

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Interventions

DIAGNOSTIC_TESTStructural 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_TESTQuantitative 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_TESTDiffusion MRI

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

DIAGNOSTIC_TESTfMRI

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_TESTMR Spectroscopy

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


Locations(2)

Klinik Lengg

Zurich, Switzerland

University Hospital Zurich

Zurich, Switzerland

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NCT05524493


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