Clinical trial NCT05524493: High-field MR Imaging in Migraine, Visual Snow and Epilepsy
Official title: High-field MR Imaging in Migraine, Visual Snow and Epilepsy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Migraine
Epilepsy
Visual Snow Syndrome
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Balgrist University Hospital
First posted: 2022-09-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be recruited from the primary care clinics as well as from referring physicians or other clinics.

Healthy controls will be recruited via public announcements and via flyers distributed at a primary care clinic and two universities.

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.


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
* 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)

Primary outcomes:
measure: MR: multi-parameter mapping (MPM)
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR: quantitative susceptibility mapping (QSM)
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: Resting-state fMRI (brain and brainstem/spinal cord)
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR: whole-brain structural scans
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR: routine clinical scans
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR spectrosocpy
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR: diffusion imaging
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: MR: axial T2*w sequence
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: Task-fMRI
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
Secondary outcomes:
measure: Migraine patients: number of migraine attacks, intensity of migraine attacks (intensity 0 - 10), duration, accompanying symptoms, Migraine diary
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Migraine patients: Headache-attributed restriction, disability, social handicap and impaired participation (HARDSHIP) questionnaire
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Migraine/ epilepsy/ visual snow syndrome patients: recording of possible other headache disorders and medication overuse
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: HADS questionnaire (Hospital anxiety and depression scale)
timeFrame: 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)
measure: Acute medication
timeFrame: 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)
measure: Epilepsy patients: diagnosis and classification according to ILAE
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Epilepsy patients: current anticonvulsant medication
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Epilepsy patients: seizure frequency
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Epilepsy patients: analysis of previous EEG examinations with determination of the epileptic focus (hemisphere, localization)
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Epilepsy patients: analysis of previous EEG examinations with qualitative assessment of the EEG to determine the type of epilepsy-specific abnormalities
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Migraine patients: documentation of previous therapy attempts
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Epilepsy patients: documentation previous therapy attempts
timeFrame: Once during visit 1 (1-2 weeks prior to visit 2)
measure: Visual snow syndrome: Puledda Questionnaire
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
measure: Migraine: Dizziness Handicap Inventory (DHI)
timeFrame: Once during visit 2 (1-2 weeks after visit 1)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik Lengg
city: Zürich
country: Switzerland
facility: University Hospital Zurich
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof. Dr. med. Dr. rer. nat.
role: PRINCIPAL_INVESTIGATOR
References: