Migraine, Epilepsy, Visual Snow Syndrome
Conditions
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.
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.
Sponsors
Balgrist University Hospital
University of Zurich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MR: whole-brain structural scans | Once during visit 2 (1-2 weeks after visit 1) |
| Task-fMRI | 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) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epilepsy patients: seizure frequency | 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) | 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 | Once during visit 1 (1-2 weeks prior to visit 2) | — |
| Migraine patients: documentation of previous therapy attempts | Once during visit 1 (1-2 weeks prior to visit 2) | Which type of therapy (medication, behavioral therapy or neuromodulation) |
| Epilepsy patients: documentation previous therapy attempts | Once during visit 1 (1-2 weeks prior to visit 2) | Which type of therapy (medication, surgical intervention or neurostimulation) |
| Visual snow syndrome: Puledda Questionnaire | Once during visit 2 (1-2 weeks after visit 1) | The higher the score, the higher the impact of visual snow |
| Migraine: Dizziness Handicap Inventory (DHI) | Once during visit 2 (1-2 weeks after visit 1) | Score from 0-100, the higher the score, the higher the vertigo impact |
| 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) | Modified questionnaire including personal and socio-demographic, diagnostic questions related to migraine, and enquiry into headache-related burden without strict scale |
| 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) | 0-42, higher score \> higher probability of anxiety/ depression |
| 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) | — |
| Epilepsy patients: diagnosis and classification according to ILAE | Once during visit 1 (1-2 weeks prior to visit 2) | — |
| Epilepsy patients: current anticonvulsant medication | Once during visit 1 (1-2 weeks prior to visit 2) | — |
Countries
Switzerland
Contacts
Primary ContactLynn Farner, MSc
Outcome results
None listed