Development and Validation of a Novel Functional Eye-Tracking Software Application for Neurological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.
研究概览
简要总结
This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.
This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by neurological disorders and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of neurological disorders and associated cognitive changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Aged 18 years old and above
- •A score of ≥ 26 on the Montreal Cognitive Assessment (MoCA)
- •Able to provide informed consent
- •Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc are permitted).
排除标准
- •Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
- •Evidence or history of significant neurological disorder (e.g. MS, PD, ALS, Dementia)
- •Use of prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics, and anticonvulsants.
- •Diagnosed with an active substance use disorder.
- •History of stroke.
- •Recent traumatic brain injury (within the last 6 months).
研究组 & 干预措施
Healthy Control
Participant with no evidence or history of significant neurodegenerative disorder affecting brain function.
干预措施: Eye-tracking (Device)
结局指标
主要结局
Symbol Digit Modalities Test (SDMT) score, one time, at the day of enrolment.
时间窗: Baseline
The SDMT is used to assess divided attention, visual scanning, tracking and motor speed. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Scoring involves summing the number of correct substitutions within the 90 second interval.
次要结局
- Multiple sclerosis functional composite (MSFC) score, one time, at the day of enrolment.(Baseline)
- The Mini-Mental State Exam (MMSE) score, one time, at the day of enrolment.(Baseline)
- The Hopkins Verbal Learning Test-Revised (HVLT-R) score, one time, at the day of enrolment.(Baseline)
- The Controlled Oral Word Association Test (COWAT) score, one time, at the day of enrolment.(Baseline)
- Brief International Cognitive Assessment for MS (BICAMS) score, one time, at the day of enrolment.(Baseline)
- The Beck Anxiety Inventory (BAI), one time at the day of enrolment.(Baseline)
- The Montreal Cognitive Assessment (MoCA) score, one time, at the day of enrolment.(Baseline)
- The Trail Making Test (TMT) Parts A & B score, one time, at the day of enrolment.(Baserline)
- The Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), one time, at the day of enrolment.(Baseline)