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

University of Zurich200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Migraine Epilepsy Visual Snow Syndrome

Interventions

Structural MRI

Quantitative MRIDIAGNOSTIC_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).

fMRIDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Klinik Lengg

Zurich, Switzerland

RECRUITING

University Hospital Zurich

Zurich, Switzerland

RECRUITING

Outcomes

Primary Outcomes

MR: multi-parameter mapping (MPM)

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

MR: quantitative susceptibility mapping (QSM)

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

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

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

MR: whole-brain structural scans

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

MR: routine clinical scans

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

MR spectrosocpy

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

MR: diffusion imaging

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

MR: axial T2*w sequence

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

Task-fMRI

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

Secondary Outcomes

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)

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

Time frame: 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

Time frame: 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

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)

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)

Epilepsy patients: diagnosis and classification according to ILAE

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

Epilepsy patients: current anticonvulsant medication

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

Epilepsy patients: seizure frequency

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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

Time frame: 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

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

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

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts