Brain Scintigraphy in Normal Versus Kleine-Levin Syndrome Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Brain perfusion.
研究概览
简要总结
The investigators perform neuropsychological tests and brain scintigraphy in 30 healthy subjects.
These results will be compared with data obtained out of episode in patients with Kleine-Levin syndrome (KLS).
The investigators want to determine if brain functional imaging and cognitive abnormalities persist during asymptomatic period in a large series of patients with KLS, and to find predictors of these abnormalities.
详细描述
3 steps in the protocol :
- Brain ECD-SPECT (marking brain perfusion in relation to brain active/hypoactive area) superimposed on a template T1-weighted brain MRI.
- Extensive cognitive tests of executive functions, verbal memory and fluency , visuospatial ability and memory, reasoning abilities: spontaneous memory complaint, Stroop Color Word Test, Trail Making Test A and B, Direct and Reverse Digit Span Test, Letter and Semantic Fluency Test, Free and Cued Selective Reminding Test, Rey-Osterrieth Complex Figure, Mini-Mental test, Progressive matrice of Raven (PM-38)
- KLS-inventory and face to face interview of patients and parents by neurologist for patients. Modified KLS-inventory for healthy subjects.
Main outcome : Number of patients with persisting hypoperfused brain area (compared to controls), location of these area, number of patients with at least -1SD in one cognitive domain Correlation between KLS severity (disease course, number of episode, mean duration of episodes, time incapacitated, number of symptoms) and brain perfusion and cognitive abnormalities
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Brain perfusion.
时间窗: day 0
Brain perfusion measured by scintigraphy with injection of Neurolite® (ECD) with a voxel by voxel approach
次要结局
未报告次要终点