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

Обзор

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.

Вмешательства

• Диагностический тест 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
• Диагностический тест 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).
• Диагностический тест Diffusion MRI
  We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.
• Диагностический тест 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.
• Диагностический тест MR Spectroscopy
  We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Первичные конечные точки

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

Вторичные конечные точки (12)

• Migraine patients: number of migraine attacks, intensity of migraine attacks (intensity 0 - 10), duration, accompanying symptoms, Migraine diary [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• Migraine patients: Headache-attributed restriction, disability, social handicap and impaired participation (HARDSHIP) questionnaire [Срок оценки: 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 [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• HADS questionnaire (Hospital anxiety and depression scale) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• Epilepsy patients: current anticonvulsant medication [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• Epilepsy patients: seizure frequency [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• Migraine patients: documentation of previous therapy attempts [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]
• Epilepsy patients: documentation previous therapy attempts [Срок оценки: Once during visit 1 (1-2 weeks prior to visit 2)]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 2 центра

• Klinik Lengg — Zurich
• University Hospital Zurich — Zurich

Идентификаторы

NCT: NCT05524493 · 2022-00936

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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