Spontaneous Eye Blinking as a Diagnostic and Prognostic Marker in Patients With Disorders of Consciousness After Severe Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 8
- 主要终点
- Clinical Diagnosis
研究概览
简要总结
Differential diagnosis between Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS) is complicated due to severe cognitive and/or sensorimotor deficits in these patients. In this study the investigators aimed at exploring the diagnostic and prognostic validity of spontaneous eye blinking parameters (rate, amplitude, duration, variability) in a sample of patients with Disorders of Consciousness (DoC).
This is a multi-center prospective observational study conducted in patients with Severe Acquired Brain Injury (sABI) and DoC admitted to 8 European participating centers, with clinical data collection not deviating from routine practice. The study is non-commercial and will have a maximum total duration of 24 months.
详细描述
Observational, multicenter, longitudinal study. In this study, all patients admitted to the nine participating centers with diagnosis of DoC, and meeting the inclusion/exclusion criteria, will be enrolled.
The admission of a patient to the research program is subject to the signing of an informed consent by the legal representative/primary caregiver of the patient. The representative will be informed about the study and its objectives, and an informational sheet will be provided.
Population All patients with DoC after sABI consecutively admitted to participating centers who meet the inclusion/exclusion criteria (see below).
Sample size On the basis of the effect size found in a previous study regarding the diagnostic value of eye blink rate (d=0.68), it is planned to enroll 58 patients with DoC (power=0.8; α=0.05) + an additional 20% to cope with possible drop-outs, for a total of 70 patients (23 in UWS, 23 in MCS minus; 23 in MCS plus; about 9 patients per center). For the secondary outcomes (i.e., diagnostic and prognostic value of further blink features) there is no previous data in the literature. In addition, a sample of 23 healthy individuals, balanced in terms of sex and age with the patient sample, will be enrolled as a reference group.
Data collection procedure Within two weeks from study entry, patients will undergo two 20-minute resting electroencephalogram-electrooculogram (EEG-EOG) examinations, separated by 24 hours. Sessions will take place, following standard nursing procedures, between 10:00 AM and 5:00 PM, a time window minimally influenced by circadian peaks of drowsiness in patients with DoC, and a period during which it is believed that EBR is stable in healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •clinical diagnosis of DoC (UWS, MCS minus, MCS plus) following repeated clinical evaluation (at least four CRS-R in a week)
- •age ≥ 18 years
- •time post-onset ≤6 months
- •Previous sABI of any etiology (traumatic, vascular, anoxic, mixed, etc.)
- •Negative anamnesis for neurological or psychiatric disorders.
排除标准
- •unstable clinical conditions (e.g. respiratory failure, fever, status epilepticus, etc.);
- •ophthalmic diseases, or clinically detected peripheral damage in eyelid motility (e.g. orbital fracture);
- •intake of sedative drugs in the preceding 24 hours;
- •additional brain event following admission (e.g., stroke).
研究组 & 干预措施
Patients with DoC consecutively admitted to participating units and met the inclusion criteria
Patients in VS or MCS due to severe acquired brain injury with different etiology (traumatic, anoxic, vascular) consecutively admitted at participating neurorehabilitation units. The total sample will be composed of 70 patients (n=9 pts per participating unit).
结局指标
主要结局
Clinical Diagnosis
时间窗: 6 months from enrollment
Clinical diagnosis as assessed by the Coma Recovery Scale-Revised (min. - max- score = 0-23, with higher scores indicating a higher level of consciousness)
次要结局
未报告次要终点