Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease: a Clinical and Neuropsychological Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- White matter hyperintensities volume change
研究概览
简要总结
Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Those of them with apnea/hypopnea index under 5 will be enrolled. Brain MRI and cognitive assessment will be performed at baseline and in 1-year follow-up, sleep quality will be assessed at baseline with self-reported questionnaires. Progression of cerebral small vessel disease markers and cognitive dysfunction will be compared between patients with high periodic limb movement index (the number of periodic limb movement ≥ 15 per hour of sleep) and controls (periodic limb movement index < 15/h).
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
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of a cerebral small vessel disease - assessed by MRI.
- •Ability to follow the procedures of the study, fluent Russian language - assessed by self-report.
排除标准
- •History of symptomatic stroke, brain tumor or traumatic brain injury - assessed by self-report and clinical history.
- •History of severe psychiatric comorbidities other than anxiety and depression, substance use disorder - assessed by self-report and clinical history.
- •Significant visual loss (leading to difficulties with performing cognitive tasks) - assessed by self-report and clinical history.
- •Presence of dementia - assessed by history and clinical examination.
- •Movement disorders (e.g. tremor, dystonia etc.) leading to lower velocity of performing cognitive tasks against the clock - assessed by clinical examination.
- •Obstructive sleep apnea syndrome - according to the criteria of International classification of sleep disorders III.
- •Restless legs syndrome - according to the criteria of the International restless legs syndrome study group.
- •Current intake of neuroleptics, benzodiazepines, selective serotonin reuptake inhibitors - assessed by self-report and clinical history.
结局指标
主要结局
White matter hyperintensities volume change
时间窗: 1 year
All the images will be processed with online software pipeline to make an automated volumetric measurement of white matter hyperintensities. The volume of the white matter lesion will be calculated separately for the periventricular, juxtacortical, infratentorial and deep white matter areas as well as total volume of the lesion. Baseline volumes will be subtracted from follow-up volumes to obtain absolute white matter hyperintensities volume change.
Degree of Cognitive Decline
时间窗: 1 year
The scores of cognitive tests (Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic and semantic verbal fluency assessment, Symbol Digit Modalities Test) at baseline will be subtracted from the corresponding baseline scores. The obtained difference reflects the degree of cognitive decline in 1 year.
次要结局
未报告次要终点