High-field MR Imaging in Migraine, Visual Snow and Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- MR: quantitative susceptibility mapping (QSM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
MR: quantitative susceptibility mapping (QSM)
时间窗: Once during visit 2 (1-2 weeks after visit 1)
Resting-state fMRI (brain and brainstem/spinal cord)
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR: whole-brain structural scans
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR: routine clinical scans
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR: diffusion imaging
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR: axial T2*w sequence
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR: multi-parameter mapping (MPM)
时间窗: Once during visit 2 (1-2 weeks after visit 1)
Task-fMRI
时间窗: Once during visit 2 (1-2 weeks after visit 1)
MR spectrosocpy
时间窗: Once during visit 2 (1-2 weeks after visit 1)
次要结局
- 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(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(Once during visit 1 (1-2 weeks prior to visit 2))
- HADS questionnaire (Hospital anxiety and depression scale)(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(Once during visit 1 (1-2 weeks prior to visit 2))
- Epilepsy patients: documentation previous therapy attempts(Once during visit 1 (1-2 weeks prior to visit 2))
- Visual snow syndrome: Puledda Questionnaire(Once during visit 2 (1-2 weeks after visit 1))
- Migraine: Dizziness Handicap Inventory (DHI)(Once during visit 2 (1-2 weeks after visit 1))