Health TrialsbyHealthPanel

High-field MR Imaging in Migraine, Visual Snow and Epilepsy

ConditionsMigraineEpilepsyVisual Snow Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Zurich

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Patient must be able to read and sign the informed consent form

Stable prophylactic medication for 2 months prior to MRI

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

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Structural MRI

    Diagnostic 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 MRI

    Diagnostic 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 MRI

    Diagnostic test

    We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.

  • fMRI

    Diagnostic 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 Spectroscopy

    Diagnostic test

    We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Healthy participants5 interventions
Group B: Patients with migraine5 interventions
Group C: Patients with drug resistent epilepsy5 interventions
Group D: Patients with visual snow syndrome5 interventions

Trial outcomes

Primary outcomes

1

MR: multi-parameter mapping (MPM)

Time frame
Once during visit 2 (1-2 weeks after visit 1)
2

MR: quantitative susceptibility mapping (QSM)

Time frame
Once during visit 2 (1-2 weeks after visit 1)
3

Resting-state fMRI (brain and brainstem/spinal cord)

Time frame
Once during visit 2 (1-2 weeks after visit 1)
4

MR: whole-brain structural scans

Time frame
Once during visit 2 (1-2 weeks after visit 1)

Secondary outcomes

1

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)
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

Time frame
Once during visit 1 (1-2 weeks prior to visit 2)
3

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)
4

HADS questionnaire (Hospital anxiety and depression scale)

0-42, higher score \> higher probability of anxiety/ depression

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Zurich

Lead sponsor

Balgrist University Hospital

Collaborator

Source ClinicalTrials.gov
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