High-field MR Imaging in Migraine and Epilepsy

Epilepsy Clinical Trial

Official title:

High-field MR Imaging in Migraine and Epilepsy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05524493
• Other study ID #: 2022-00936
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: Lynn Farner, MSc
• Phone: +41 44 510 72 08
• Email: lynn.farner[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Epilepsy
• Migraine
• Migraine Disorders

Intervention

Diagnostic Test:
• Structural MRI
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
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
We will examine migraine and epilepsy patients as well as healthy controls using diffusion MRI in both brain and spinal cord.
• fMRI
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
We will examine migraine and epilepsy patients as well as healthy controls using MR Spectroscopy in both brain and spinal cord.

Locations

Country	Name	City	State
Switzerland	Klinik Lengg	Zürich
Switzerland	University Hospital Zurich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MR: multi-parameter mapping (MPM)		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR: quantitative susceptibility mapping (QSM)		Once during visit 2 (1-2 weeks after visit 1)
Primary	Resting-state fMRI (brain and brainstem/spinal cord)		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR: whole-brain structural scans		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR: routine clinical scans		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR spectrosocpy		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR: diffusion imaging		Once during visit 2 (1-2 weeks after visit 1)
Primary	MR: axial T2*w sequence		Once during visit 2 (1-2 weeks after visit 1)
Primary	Task-fMRI		Once during visit 2 (1-2 weeks after visit 1)
Secondary	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)
Secondary	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)
Secondary	Migraine/ epilepsy patients: recording of possible other headache disorders and medication overuse		Once during visit 1 (1-2 weeks prior to visit 2)
Secondary	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)
Secondary	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)
Secondary	Epilepsy patients: diagnosis and classification according to ILAE		Once during visit 1 (1-2 weeks prior to visit 2)
Secondary	Epilepsy patients: current anticonvulsant medication		Once during visit 1 (1-2 weeks prior to visit 2)
Secondary	Epilepsy patients: seizure frequency		Once during visit 1 (1-2 weeks prior to visit 2)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)