Evaluation of Brain Changes in Cerebral Palsy Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Total brain volume
研究概览
简要总结
Cerebral palsy (CP) is a neurodevelopmental syndrome characterized by sensorimotor impairment that arises during early childhood defined as a static insult to the developing brain. A key part of the definition for CP is a non-progressive brain injury; however, as individuals with CP age, a functional decline greater than neurotypical individuals is often present. The investigators are doing this research study to improve understanding of whether there is brain and spinal cord atrophy over time that could indicate neurodegeneration. To do this, the investigators will partner with the Cerebral Palsy Research Network to obtain brain and spinal cord MRIs from people with CP across the United States. The investigators will perform analyses on multiple longitudinal MR images of the brain and spinal cord obtained from adults with CP. Putative changes will be related with changes in function across time.
This will be a single-center study that will compare retrospective clinical and imaging data with similar prospective data. The objective is to find out if people with Cerebral Palsy (CP) experience changes in the structures of their brain over time. A key part of the CP definition is that it is a non-progressive brain injury. However, as people with CP age, their function often deteriorates. This study seeks to determine whether changes in the brain structure may result in function changes, as they do in other types of brain injuries.
The investigators are doing this research study to improve understanding of whether there is brain and spinal cord atrophy over time that could indicate neurodegeneration. To do this, the investigators will partner with the Cerebral Palsy Research Network to obtain brain and spinal cord MRIs from people with CP across the United States, as well as locally. The investigators will perform analyses on multiple longitudinal MR images of the brain and spinal cord obtained from adults with CP. Putative changes will be related with changes in function across time.
详细描述
Cerebral palsy is a neurodevelopmental syndrome that arises during fetal or infant development. Cerebral palsy is defined by a static insult to the brain, such as hypoxia, brain ischemia from stroke or hypotension, infection, or trauma. This brain insult then gives rise to impairment in movement and posture. In developed nations, cerebral palsy accounts for the most common cause of childhood motor disability. Additionally, as medical care advances, survival into adulthood is increasing. Thus, studying the changes associated with cerebral palsy during the aging process is important to providing care to these individuals.
A key part of the cerebral palsy definition is a non-progressive brain injury. However, as people with cerebral palsy age, their function often deteriorates. This study seeks to determine whether changes to brain structure may underlie the functional changes, as they do in other traumatic or ischemic brain injuries. There are established findings of white matter changes, grey matter changes, stroke, and vascular malformation using brain MRI in cerebral palsy, although approximately 13-14% of patients imaged have no injuries visible seen on a clinical MRI brain examination.
These MRI changes are believed to be the representative static lesion(s) that occurred during fetal development or infancy and caused cerebral palsy. The investigators propose that there are structural changes identifiable through MR brain imaging in patients with cerebral palsy over time. Additionally, the clinical and functional worsening seen in cerebral palsy patients as they age may correlate with these MRI changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have multiple MRI scans of brain and/or spinal cord spaced at least 24 months apart
- •Between 18-80 years of age with at least one MRI scan after the age of 18
- •No known central or peripheral neurological disease or injury other than cerebral palsy causing brain degeneration
- •Inclusion in CPRN registry
- •diagnosis of Cerebral Palsy
- •>18 years of age
- •Have received at least one past brain MRI scan as part of standard care (patients who have two or more brain MRI scans can be included in the retrospective arm only)
排除标准
- •History of more than one seizure in lifetime
- •History of known degenerative genetic disorder
- •History of brain tumor, abscess, or multiple sclerosis
- •History of moderate or severe head trauma
- •History of metal implants in head
研究组 & 干预措施
Prospective
Patients who have only one brain MRI scan will be included in the prospective arm of the study. These patients will undergo MRIs of both the brain and cervical spine without contrast.
Retrospective
Patients who have a diagnosis of cerebral palsy, are adults (>18 years of age), and have at least one brain MRI will be identified through chart review. Those patients who have two or more brain MRI scans will be included in the retrospective arm only.
结局指标
主要结局
Total brain volume
时间窗: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years
This is a number, measured in cubic millimeters, that includes the output from segmentation of each individual MRI scan per subject.
次要结局
- Cortical thickness(From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.)
研究者
Jason Carmel
Chief of Division of Pediatric Neurology, Executive Director of Weinberg Family Cerebral Palsy Center
Columbia University