MRI for Non-invasive Evaluation of Brain Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Blood Flow and Perfusion
研究概览
简要总结
Craniosynostosis is a birth defect that causes the bones on a baby's head to fuse together earlier than normal. This causes the baby to have an abnormally shaped head. These children are operated on to prevent or treat increased pressure on the brain, allowing for normal development. There is not good evidence of which children with craniosynostosis have increased pressure on the brain. Up to twenty patients with craniofacial abnormalities will be enrolled in this pilot study. The investigators will use a magnetic resonance scanner to obtain several measures of brain metabolism. The investigators will also obtain data which are markers of developmental delay.
The results will also be compared to age and gender matched data from children without craniofacial abnormalities.
There study hypothesis is that patients with craniofacial abnormalities associated with intracranial pressure will have decreased metabolic activity compared to control patients.
详细描述
The incidence of craniosynostosis is reported to be 1/2,000 births. Craniosynostosis is a birth defect that causes one or more sutures on a baby's head to close earlier than normal. The skull of an infant or young child is made up of bony plates that allow for growth of the skull. The borders at which these plates intersect are called sutures or suture lines. Early closing of a suture causes the baby to have an abnormally shaped head.
Original contributions by Dr. Paul Tessier along with technological advances (improved pediatric anesthesia, rigid fixation, resorbable plates, endoscopic techniques and distraction) have significantly advanced surgical treatment for these patients over the past 40 years.
Primary indication for operative treatment for patients with craniosynostosis is to prevent or treat increased intracranial pressure (ICP) and avoid neurological impairment. Increased ICP is thought to result from restricted space for brain growth caused by decreased cranial vault volume. A secondary surgical indication is normalization of head shape for cosmetic purposes.
Literature is limited on the relationship between craniosynostosis and ICP. The most widely reported study is by Renier and colleagues. In 75 patients preoperative ICP monitoring was performed using an epidural sensor. They identified ICP to be normal in one-third of the cases, obviously elevated in one-third, and borderline in one-third. When counseling patients, practitioners report a 13% rate of increased ICP for single suture synostosis and 42% for multiple suture synostosis. However, the authors used adult normative values for ICP (normal less than 10mmHg and elevated greater than 15mmHg). Normal ICP in children and infants has been identified to be closer to 6 mmHg.
Due to the invasiveness of the test, preoperative ICP monitoring is not routinely performed to decide if operative repair is required. Other indirect signs of increased intracranial pressure have been described (e.g., copper beaten appearance of the skull on plain film, papilledema, comparing intracranial volume to normative data), but are not reliable. Currently, the standard of care is to surgically treat all patients with craniosynostosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients presenting to the Plastic Surgery or Neurosurgery clinics with scheduled sedated MRI and abnormalities such as hydrocephalus (and possibly some patients to be used as controls who present to the clinic with no known skull or brain abnormalities)
排除标准
- •history of abnormalities known to affect brain topology or function
- •implants (e.g. pacemakers) that might rule out use of MR scanning.
结局指标
主要结局
Blood Flow and Perfusion
时间窗: during the single MRI scan, approximately 30 - 45 minutes
To be measured with both oxygen extraction fraction and arterial spin labeling to measure blood flow.
次要结局
未报告次要终点
