MigraineNCT05524493
High-field MR Imaging in Migraine, Visual Snow and Epilepsy
An observational study of Migraine and Epilepsy, run by University of Zurich at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Epilepsy, Visual Snow Syndrome
- What is being tested?
- Structural MRI, Quantitative MRI and Diffusion MRI
- How many people
- 200 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Mar 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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,
Show all 13Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Klinik Lengg
Zurich, 8008
Lukas Imbach, PD Dr. med., +41 44 387 63 02, lukas.imbach@kliniklengg.ch
- Recruiting
University Hospital Zurich
Zurich, 8091
Lars Michels, PD Dr., +41 44 255 49 65, lars.michels@usz.ch
Heiko Pohl, Dr. med., +41 44 255 55 11, heiko.pohl@usz.ch
About this study
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.
- Conditions
- Migraine, Epilepsy, Visual Snow Syndrome
- Being tested
- Structural MRI, Quantitative MRI, Diffusion MRI, fMRI, MR Spectroscopy
- Medical subject headings
- Migraine Disorders, Epilepsy, visual snow syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structural MRIDiagnostic test
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
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).
Diffusion MRIDiagnostic test
We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.
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.
MR SpectroscopyDiagnostic test
We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Not described Receives: Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy | |
| Patients with migraine | Not described Receives: Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy | |
| Patients with drug resistent epilepsy | Not described Receives: Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy | |
| Patients with visual snow syndrome | Not described Receives: Diagnostic Test: Structural MRI; Diagnostic Test: Quantitative MRI; Diagnostic Test: Diffusion MRI; Diagnostic Test: fMRI; Diagnostic Test: MR Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR: multi-parameter mapping (MPM)
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR: quantitative susceptibility mapping (QSM)
Measured: Once during visit 2 (1-2 weeks after visit 1)
Resting-state fMRI (brain and brainstem/spinal cord)
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR: whole-brain structural scans
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR: routine clinical scans
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR spectrosocpy
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR: diffusion imaging
Measured: Once during visit 2 (1-2 weeks after visit 1)
MR: axial T2*w sequence
Measured: Once during visit 2 (1-2 weeks after visit 1)
Task-fMRI
Measured: Once during visit 2 (1-2 weeks after visit 1)
Secondary outcomes (14)
Migraine patients: number of migraine attacks, intensity of migraine attacks (intensity 0 - 10), duration, accompanying symptoms, Migraine diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: current anticonvulsant medication
Measured: Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: seizure frequency
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: Once during visit 2 (1-2 weeks after visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Balgrist University Hospital
- Responsible party
- Sponsor
- Investigators
- Patrick Freund, Prof. Dr. med. Dr. rer. nat., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524493
- Sponsor's protocol ID
- 2022-00936
- Status last verified
- Oct 2025
- First submitted
- 18 Aug 2022
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-field MR Imaging in Migraine, Visual Snow and Epilepsy
- ClinicalTrials.gov ID
- NCT05524493
- Acronym / sponsor ID
- 2022-00936
- Conditions
- Migraine, Epilepsy, Visual Snow Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Balgrist University Hospital
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Diagnostic Test: Structural MRI, Diagnostic Test: Quantitative MRI, Diagnostic Test: Diffusion MRI, Diagnostic Test: fMRI, Diagnostic Test: MR Spectroscopy |
| Patients with migraine | – | Diagnostic Test: Structural MRI, Diagnostic Test: Quantitative MRI, Diagnostic Test: Diffusion MRI, Diagnostic Test: fMRI, Diagnostic Test: MR Spectroscopy |
| Patients with drug resistent epilepsy | – | Diagnostic Test: Structural MRI, Diagnostic Test: Quantitative MRI, Diagnostic Test: Diffusion MRI, Diagnostic Test: fMRI, Diagnostic Test: MR Spectroscopy |
| Patients with visual snow syndrome | – | Diagnostic Test: Structural MRI, Diagnostic Test: Quantitative MRI, Diagnostic Test: Diffusion MRI, Diagnostic Test: fMRI, Diagnostic Test: MR Spectroscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structural MRIWe 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 test | Healthy participants, Patients with drug resistent epilepsy, Patients with migraine, Patients with visual snow syndrome |
| Quantitative MRIWe 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 test | Healthy participants, Patients with drug resistent epilepsy, Patients with migraine, Patients with visual snow syndrome |
| Diffusion MRIWe will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord. | Diagnostic test | Healthy participants, Patients with drug resistent epilepsy, Patients with migraine, Patients with visual snow syndrome |
| fMRIWe 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 test | Healthy participants, Patients with drug resistent epilepsy, Patients with migraine, Patients with visual snow syndrome |
| MR SpectroscopyWe will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord. | Diagnostic test | Healthy participants, Patients with drug resistent epilepsy, Patients with migraine, Patients with visual snow syndrome |
Primary outcome
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)
14 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
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)
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
Time frame: Once during visit 1 (1-2 weeks prior to visit 2)
Epilepsy patients: documentation previous therapy attempts
Time frame: Once during visit 1 (1-2 weeks prior to visit 2)
Visual snow syndrome: Puledda Questionnaire
Time frame: Once during visit 2 (1-2 weeks after visit 1)
Migraine: Dizziness Handicap Inventory (DHI)
Time frame: Once during visit 2 (1-2 weeks after visit 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
Related trials for Migraine
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Freund, Prof. Dr. med. Dr. rer. nat. principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Epilepsy, run by University of Zurich at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lynn Farner, MSc (+41 44 510 72 08, lynn.farner@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR: multi-parameter mapping (MPM) (time frame: Once during visit 2 (1-2 weeks after visit 1)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.