Monitoring of Neurodegenerative Processes in Children With Multiple Sclerosis by Diffusion-weighed Magnetic Resonance Imaging (DTI)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences
研究概览
简要总结
This is a prospective, non-randomised, non-blinded, single center study of children and adolescents with multiple sclerosis and clinically isolated syndrome to detect differences or early changes in diffusion-weighted imaging (DTI) by magnetic resonance imaging (MRI).
详细描述
In children and adolescents with either multiple sclerosis or clinically isolated syndrome an MRI with special DTI-sequences of the brain is performed at timepoint of first manifestation of disease and every 6 months at 3 Tesla MRI according to a specific investigation protocol.
Besides MRI-DTI several clinical data are recorded every 6 months:
- expanded disability status scale (EDSS)
- disease activity/ relapse rate
- lesion load (number of T2-lesions)
- brain atrophy
- visual and somatosensoric evoked potentials (VEP, SSEP)
- neuropsychological examination
Furthermore a complete neurological examination is done every 6 months and particular medication of each patient is recorded in a specific investigator form (case report form, CRF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •informed consent
- •diagnosis of multiple sclerosis (MS) according to the McDonald criteria 2010 and the consensus recommendations of International Pediatric MS Study Group (IPMSSG) (Krupp et al 2013)
- •diagnosis of CIS according to the consensus recommendation of IPMSSG (Krupp et al 2013)
- •all types of medication/therapy
排除标准
- •pregnancy
- •claustrophobia
- •allergic reaction of gadolinium (contrast medium)
- •implantation of cardiac device
- •implantation of neurostimulators
- •implantation of cochlea implants
- •presence of tattooing (over 20% of body surface)
- •presence of permanent-make-up
- •presence of permanent transdermal patches
- •presence of special catheter systems with temperature probes which cannot be removed
- •implantation of metalliferous implants or implants which could contain metal traces
- •implantation of artificial heart valves
- •implantation of stents or coils
- •presence of metal fragments in the eyes
结局指标
主要结局
change from baseline apparent diffusion coefficient (ADC) at 36 months measured by cerebral MRI and special DTI sequences
时间窗: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measured by cerebral MRI and special DTI sequences
change from baseline fractional anisotropy (FA) at 36 months measured by cerebral MRI and special DTI sequences
时间窗: every 6 months (from date of randomization until the end of the study, assessed up to 36 months)
measured by cerebral MRI and special DTI sequences
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(every 6 months (from date of randomization until the end of the study, assessed up to 36 months))
- EDSS (Expanded disability status scale, Values between 0-10)(every six months (from date of randomization until the end of the study, assessed up to 36 months))
- SSEP somatosensory evoked potentials, records of amplitudes and latency(every 12 months (from date of randomization until the end of the study, assessed up to 36 months))
- Disease activity (relapse rate, lesion load)(every 6 months (from date of randomization until the end of the study after 36 months))
- spinal lesion load measured by spinal MRI (which is performed in each participant every 12 months)(every 12 months (from date of randomization until the end of the study, assessed up to 36 months))
- VEP-Score(every 6 months (from date of randomization until the end of the study, assessed up to 36 months))
- Medication particular medication of each patient(every 6 months (from date of randomization until the end of the study, assessed up to 36 months))
- neurocognitive deficits neuropsychological test battery(every 12 months (from date of randomization until the end of the study, assessed up to 36 months))