Spontaneous Eye Blinking Evaluation for Cognitive Assessment of Individuals With Severe Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Coma Recovery Scale-Revised
研究概览
简要总结
Assessment of consciousness and attention in individuals with severe Acquired Brain Injury (sABI) is crucial for planning rehabilitation, but it is often hindered by coexisting sensory-motor and/or cognitive-behavioural disorders.
This project aims at evaluating the value of spontaneous eye blinking features to assess patients' attentional abilities and to distinguish patients with unresponsive wakefulness syndrome (UWS) from those in minimally conscious state (MCS).
Patients will undergo an EEG-EOG recording at rest and during an auditory oddball task. Eye blinking features on EOG will be analysed and compared to that of healthy individuals. A machine-learning-based algorithm using blinking features for the diagnosis of patients with sABI will be studied and validated preliminarily.
This project will help to stratify patients with sABI using easy-to-detect clinical markers, supporting clinicians' decision-making about patient's management. Additionally, blinking patterns related to residual attentional abilities in patients emerged from disorders of consciousness will be investigated.
详细描述
Overall aim: to provide preliminary results on the value of spontaneous eye blinking features (i.e., rate, amplitude, duration, and variability in intervals between blinks), which do not rely on voluntary behavioural responses, for improving the assessment of attentional abilities and consciousness in patients with sABI.
Specific aims:
- to confirm the diagnostic value of EBR in pDoC patients, as in Magliacano et al.'s (2021) study;
- to improve diagnostic accuracy of patients with prolonged Disorders of Consciousness (pDoC) by evaluating additional blinking features (i.e., amplitude, duration, variability in intervals between blinks) for discriminating patients in UWS from those in MCS or conscious.
- to explore the usefulness of eye blinking features analysis for assessing residual attentional abilities in full-conscious patients recovering from pDoC.
- prototyping a machine-learning-enabled pipeline for supporting consciousness diagnosis based on Eye Blink Rate (EBR) and EOG-derived features. The interpretability and reliability aspects will be carefully evaluated to obtain a clinically usable solution for supporting diagnostic procedures and planning tailored cognitive rehabilitation.
Overall, this study is proposing a preliminary investigation, with pilot samples of both healthy and test population, for the analysis of EBR and EOG-derived biomarkers. These results will lay the foundations for the development and validation of multifactorial decisional algorithms for patients' diagnostic and prognostic stratification, based on easily collectable clinical markers.
This project has an observational, cross-sectional design. All patients with sABI consecutively admitted will be screened. We plan to enrol a convenience test sample of 35 patients with sABI including 10 patients with pDoC (5 in UWS, 5 in MCS) and 25 patients who recovered full consciousness after sABI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •diagnosis of severe acquired brain injury;
- •age≥18 years;
- •time post-injury≥28 days
- •written informed consent by patient or, where necessary, by primary caregiver
排除标准
- •large craniectomy interfering with EEG recording;
- •unstable clinical conditions;
- •presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation;
- •administration of sedative medication in the previous 24h;
- •previous history of neurological or psychiatric diseases
研究组 & 干预措施
Patients with severe acquired brain injury
Patients' inclusion criteria: (i) age≥18 years; (ii) time post-injury≥28 days. Exclusion criteria will be: (i) large craniectomy interfering with EEG recording; (ii) unstable clinical conditions; (iii) presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation; (iv) administration of sedative medication in the previous 24h; (v) previous history of neurological or psychiatric diseases; (vi) written informed consent by patient or, where necessary, by primary caregiver.
干预措施: EEG-EOG recording at rest and during an auditory oddball paradigm (Diagnostic Test)
Benchmark sample
i) age≥18 years; ii) normal or corrected-to-normal vision excluding contact lenses; iii) a total score >22.23 at the Montreal Cognitive Assessment (Santangelo et al., 2015); iv) written informed consent. Exclusion criteria: i) presence of ophthalmic disorders, or central or peripheral impairments in eyelid motility on clinical evaluation; ii) consumption of drugs acting on the central nervous system; iii) previous history of neurologic or psychiatric diseases.
干预措施: EEG-EOG recording at rest and during an auditory oddball paradigm (Diagnostic Test)
结局指标
主要结局
Coma Recovery Scale-Revised
时间窗: Within 2 weeks from study entry
The Coma Recovery Scale-Revised is a clinical scale with a total score ranging from 0 to 23, with higher scores indicating a higher level of consciousness
Levels of Cognitive Functioning
时间窗: Within 2 weeks from study entry
Levels of Cognitive Functioning is a clinical scale with a score ranging from 1 to 8, with higher scores indicating a higher level of cognitive functioning
次要结局
未报告次要终点
研究者
Alfonso Magliacano
Researcher
Fondazione Don Carlo Gnocchi ETS