High-field MR Imaging in Migraine, Visual Snow and Epilepsy
- Conditions
- MigraineEpilepsyVisual Snow Syndrome
- Interventions
- Diagnostic Test: Structural MRIDiagnostic Test: Quantitative MRIDiagnostic Test: Diffusion MRIDiagnostic Test: fMRIDiagnostic Test: MR Spectroscopy
- Registration Number
- NCT05524493
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy participants Diffusion MRI - Patients with migraine Structural MRI - Patients with migraine MR Spectroscopy - Patients with migraine Quantitative MRI - Healthy participants Quantitative MRI - Healthy participants MR Spectroscopy - Healthy participants Structural MRI - Healthy participants fMRI - Patients with migraine Diffusion MRI - Patients with drug resistent epilepsy Structural MRI - Patients with drug resistent epilepsy Diffusion MRI - Patients with drug resistent epilepsy fMRI - Patients with migraine fMRI - Patients with drug resistent epilepsy MR Spectroscopy - Patients with drug resistent epilepsy Quantitative MRI -
- Primary Outcome Measures
Name Time Method MR: diffusion imaging 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) MR: whole-brain structural scans 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: 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) Task-fMRI Once during visit 2 (1-2 weeks after visit 1) MR spectrosocpy Once during visit 2 (1-2 weeks after visit 1)
- Secondary Outcome Measures
Name Time Method 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) 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
Trial Locations
- Locations (2)
University Hospital Zurich
🇨🇭Zürich, Switzerland
Klinik Lengg
🇨🇭Zürich, Switzerland