A Digital Protocol for Neurological Examination Using Eye-Tracking
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- System Usability Scale (SUS)
研究概览
简要总结
The neurological examination (NE) is a cornerstone of clinical neurology, with ocular motor assessment being a key component. Technology offers an opportunity to augment and standardize parts of the NE. Eye-tracking systems provide objective quantitative data on eye movements by continuously tracking the eye over time. This data can be used to derive parameters like saccadic latency, gaze velocity, and fixation stability with a precision that is impossible to achieve through human observation by neurologists. The integration of such technology could enhance the traditional NE.
Before such technology can be widely adopted, its feasibility and acceptability in a clinical population must be established. The primary purpose of this study is to assess the usability of a novel eye-tracking system from the patient's perspective when used in a clinical settings. A secondary purpose is to determine if quantitative data from the eye-tracker correlate with the findings of the traditional clinical neurological examination and to explore whether eye-tracking can provide additional, complementary information not typically captured by standard clinical assessment.
To achieve these aims, the study will assess several outcome measures. The primary outcome measure is the Usability of the Eye-Tracking System, which will be measured using the System Usability Scale (SUS).
Beyond the primary objectives, this study will investigate two secondary objectives.
The first involves assessing the relationship between quantitative eye-tracking parameters and clinical ocular motor assessment. Specifically, the investigators will analyze objective, numerical data obtained from eye-tracking systems and the clinician's subjectively graded assessment of ocular movements derived from the standard neurological examination.
The second is the exploratory analysis of novel eye-tracking biomarkers. This involves quantifying and analyzing eye-tracking parameters not typically assessed during a routine NE. For example, the dynamics of the pupillary light reflex or the frequency of microsaccades. The aim is to identify potential digital biomarkers that could provide additional objective insights into ocular motor function and neurological status.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •≥ 18 years of age.
- •Diagnosed or treated for a neurological disease.
- •Hospitalized or outpatient of the Department of Neurology, UKSH Campus Kiel.
- •Ability of the person to understand oral study information and study information sheet, and willingness to provide a signed and dated informed consent form.
- •Exclusion criteria:
- •Being under legal guardianship
- •Impaired decision-making capacity, or temporal or spatial disorientation which may be revealed within ordinary conversation or by a confirmed diagnosis of dementia. In case of doubt, the Montreal Cognitive Assessment (MoCA, pass cutoff score > 18 16) will be administered.
排除标准
- 未提供
结局指标
主要结局
System Usability Scale (SUS)
时间窗: Baseline (single session, approx. 2-3 hour per participant)
The System Usability Scale (SUS) is a validated and widely used 10-item questionnaire designed to assess the subjective usability of a system-in this case, a wearable eye-tracking device. Each item is rated on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). The SUS yields a single score ranging from 0 to 100, where higher scores indicate greater perceived usability. A score of 68 is generally considered average; scores above 80 indicate high usability, while scores below 50 suggest usability concerns. Usability, in this context, includes perceptions of comfort, system complexity, ease of use, learnability, and willingness to use the system regularly or independently. Participants complete the SUS immediately after using the eye-tracker in a controlled session.
次要结局
- Vestibulo-ocular reflex (VOR)(Baseline (single session, approx. 2-3 hour per participant))
- Skew deviation(Baseline (single session, approx. 2-3 hour per participant))
- Smooth pursuit (SP) number of saccades(Baseline (single session, approx. 2-3 hour per participant))
- Smooth pursuit (SP) saccade amplitude(Baseline (single session, approx. 2-3 hour per participant))
- Smooth pursuit (SP) slow phase velocity(Baseline (single session, approx. 2-3 hour per participant))
- Nystagmus at rest, quick phase(Baseline (single session, approx. 2-3 hour per participant))
- Vestibulo-ocular reflex suppression (VORS)(Baseline (single session, approx. 2-3 hour per participant))
- Pupillary reflex(Baseline (single session, approx. 2-3 hour per participant))
- Pupil size at rest(Baseline (single session, approx. 2-3 hour per participant))
- Nystagmus at rest, slow phase(Baseline (single session, approx. 2-3 hour per participant))
- Saccades velocity(Baseline (single session, approx. 2-3 hour per participant))
- Glabella reflex(Baseline (single session, approx. 2-3 hour per participant))
研究者
Walter Maetzler
Prof. Dr. med. Walter Maetzler
University of Kiel
