High-field MR Imaging in Migraine and Epilepsy

Study Overview
=================
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.

Official Title
-----------------
High-field MR Imaging in Migraine and Epilepsy

Conditions
-----------------
Epilepsy, Migraine

Intervention / Treatment
-----------------
* Diagnostic Test: Structural MRI
* Diagnostic Test: Quantitative MRI
* Diagnostic Test: Diffusion MRI
* Diagnostic Test: fMRI
* Diagnostic Test: MR Spectroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
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 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy participants<br> | Diagnostic Test: Structural MRI<br>* 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<br>Diagnostic Test: Quantitative MRI<br>* 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).<br>Diagnostic Test: Diffusion MRI<br>* We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.<br>Diagnostic Test: fMRI<br>* 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.<br>Diagnostic Test: MR Spectroscopy<br>* We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.<br>|
| Patients with migraine<br> | Diagnostic Test: Structural MRI<br>* 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<br>Diagnostic Test: Quantitative MRI<br>* 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).<br>Diagnostic Test: Diffusion MRI<br>* We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.<br>Diagnostic Test: fMRI<br>* 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.<br>Diagnostic Test: MR Spectroscopy<br>* We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.<br>|
| Patients with drug resistent epilepsy<br> | Diagnostic Test: Structural MRI<br>* 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<br>Diagnostic Test: Quantitative MRI<br>* 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).<br>Diagnostic Test: Diffusion MRI<br>* We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.<br>Diagnostic Test: fMRI<br>* 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.<br>Diagnostic Test: MR Spectroscopy<br>* We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 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) | 
| Task-fMRI |  | Once during visit 2 (1-2 weeks after visit 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Modified questionnaire including personal and socio-demographic, diagnostic questions related to migraine, and enquiry into headache-related burden without strict scale | Once during visit 1 (1-2 weeks prior to visit 2) | 
| Migraine/ epilepsy 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) | 0-42, higher score > higher probability of anxiety/ depression | 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 |  | 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 | Which type of therapy (medication, behavioral therapy or neuromodulation) | 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) | Once during visit 1 (1-2 weeks prior to visit 2) |