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临床试验/NCT05471310
NCT05471310已完成不适用

Eye-tacking Method as a Diagnostic Tool for Assessment of Oculomotor Parameters (Gaze-holding Score, Scan Path, Visually Guided Saccades Etc) in Pediatric Patients With Ataxia Telangiectasia

Federal Research Institute of Pediatric Hematology, Oncology and Immunology1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
1
主要终点
Visual search task

研究概览

简要总结

Ataxia-telangiectasia (A-T) is a multisystem auto-somal recessive disorder linked to the A-T mutated gene (ATM) on chromosome 11q22-23, and characterized by progressive neural degeneration, immunodeficiency, and progressive ocular motor dysfunction. In previous studies, the quantitative description of the ocular motor deficits from clinical examination was limited to various defects in saccade and gaze control, dysmetric saccades, impairments of smooth pursuit, gaze holding, convergence, vestibular and optokinetic nystagmus slow phases, and cancellation of the vestibulo-ocular reflex. The aim of our research is to add existing findings with quantitative description of oculomotor patterns in A-T patients using videooculography (VOG).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
8 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • confirmed diagnosis of ataxia telangiectasia,
  • informed consent,
  • stay at the Clinical Research Rehabilitation Center "Russkoe Pole" for 14 days.

排除标准

  • epilepsy,
  • poor visual acuity, inability to percept from a computer monitor,
  • inability to hold head and posture satisfactory to perform the tasks,
  • difficulty to obtain adequate recordings due to corrective lenses,
  • visual field defects.

结局指标

主要结局

Visual search task

时间窗: baseline, during the intervention-rehabilitation course (once)

Ten black circles (diameter \~1) will be presented on the monitor distributed pseudorandomly over the screen. Subjects will be instructed to count silently the number of points and give a verbal response. Study parameters: the performance time, the number of fixations, their durations, the total length of the scanning trajectory, and the saccade amplitude.

Visually guided saccade task

时间窗: baseline, during the intervention-rehabilitation course (once)

The subject will be required to follow a target jumping their gaze from one corner of the square to the next as quickly as possible as soon as a circle appeared; saccades will be required in order to do this (An image of a square with side length 10° will be presented on the monitor and a red circle (diameter \~1°) appeared in the corners sequentially in the clockwise direction.) Study parameters: the total number of saccades completed, the proportions of relatively accurate (A in the range 8.5-11.5°), hypometric (short, A \< 8.5°), and hypermetric (long, A \> 11.5°), and corrective saccades (occurring only after dysmetric saccades, 1.5° \< A \< 5°);

Gaze holding task

时间窗: baseline, during the intervention-rehabilitation course (once)

A fixation task in which the subject will require to look at a target-a green circle (diameter \~1) sequentially presented at eccentric (15 rightward and leftward, 8 upward and downward) positions, each eccentric position being sustained for 20 s. Gaze-holding score will be assessed for each circle by approximating the gaze position coordinates by the least squares method to obtain the best correspondence using the fit function. The areas of the obtained ellipses, reflecting the spread of gaze position coordinates, will be determined for each of the four circle positions in each subject. Areas will be expressed in square visual degrees (sq. deg.)

次要结局

  • Scale for the assessment and rating of ataxia(baseline, during the intervention-rehabilitation course (once))

研究者

研究点 (1)

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