Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Visual fields testing
研究概览
简要总结
The neural circuits in our brains require a layer of insulation in order to transmit signals in a rapid and efficient fashion. This insulation is called White Matter and is comprised of a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and cognitive problems. Currently there are no effective medical therapies to promote brain repair and reduce disability following damage to white matter. In this project, we hope to change the situation by encouraging the brain itself to generate new oligodendrocytes and thus new white matter. Our first step is to find measures sensitive to white matter growth.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Experienced a demyelinating event (Only applicable to patient subjects)
- •Between the ages of 5 years to 18 years and 11 months of age
- •Has either English as his or her native language or has had at least two years of schooling in English
排除标准
- •Children with non-demyelinating etiologies of white matter dysfunction (i.e., metabolic disorders, vasculitis, and non-specific MRI abnormalities
- •Is younger than 5 years of age
- •Is 18 years and 11 of age or older
- •Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy, developmental delay, or learning disability
- •Requires sedation for brain scanning
- •Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI machine
结局指标
主要结局
Visual fields testing
时间窗: 20 minutes
Clinical Interview
时间窗: 10 minutes
MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
时间窗: 90 minutes
Colour vision testing
时间窗: 10 minutes
Neurocognitive Testing
时间窗: 90 minutes
Computerized Penn Neurocognitive Battery
High contrast visual acuity
时间窗: 10 minutes
Neuronal responses during pro/anti-saccade eye movements
时间窗: 60 minutes
Video-based eye tracking monocularly in the MEG and binocularly outside the MEG
Electrical potentials initiated by brief visual stimuli
时间窗: 10 minutes
Visual Evoked Potentials (VEP)
Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
时间窗: 10 minutes
Optical coherence tomography (OCT)
时间窗: 25 minutes
Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
时间窗: 20 minutes
次要结局
未报告次要终点
研究者
E. Ann Yeh
Associate Scientist, Research Institute
The Hospital for Sick Children