Implementation of a Novel Functional Eye-Tracking Biomarker for Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
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 CIS and RRMS 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 identify which metrics-or combination thereof-can serve as reliable biomarker of CIS and RRMS disease progression and cognitive status.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For all participants
- •Able to provide informed consent
- •Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc. are permitted)
- •For patients only
- •Confirmed diagnosis of CIS with abnormal MRI or RRMS
- •Neurological condition is medically stable during the study visit
排除标准
- •For all participants:
- •Evidence or medical history of psychiatric issues, which are known to also affect movements and oculomotor control.
- •Aged above 65 or less than 18 years of age.
- •Presence of comorbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).
- •Diagnosis of macular edema or other pre-existing ocular conditions that would prevent from performing the eye movement assessments.
- •For healthy controls only:
- •Evidence or history of significant neurological disorder (Multiple Sclerosis, Parkinson's Disease, Amyotrophic Lateral Sclerosis, Dementia)
结局指标
主要结局
Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 12
时间窗: Baseline and Month 12
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. 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. 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
- Change from Baseline in the Multiple sclerosis functional composite (MSFC) scores at Month 12(Baseline and Month 12)
- Change from Baseline in the Expanded Disability Status Scale (EDSS) score at Month 12(Baseline and Month 12)
- Change from Baseline in the Brief International Cognitive Assessment for MS (BICAMS) scores at Month 12(Baseline and Month 12)