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临床试验/NCT03892356
NCT03892356Unknown不适用

Oculomotor Function Testing in Patients Who Suffered Concussions

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
self-paced saccade

研究概览

简要总结

This is a prospective longitudinal study which aims to compare oculomotor function and visual scanning behaviour (VSB) of participants who suffered concussion with healthy controls with no concussion. This study also aims to investigate the pattern of change in oculomotor function and visual scanning behaviour (VSB) in the participants over a 6-month period.

详细描述

Primary Objective

  • To identify differences in oculomotor function and visual scanning behaviour (VSB) between participant with and without acute concussion
  • To investigate patterns of change and recovery in oculomotor function and VSB in participants who suffered a concussion

Secondary Objective

• To investigate the association between the oculomotor function and concussion-related symptoms

This is a prospective longitudinal study which aims to evaluate differences in oculomotor function and visual scanning behaviour (VSB) between participants who suffered acute concussion and healthy controls with no concussion. This study also aims to investigate the pattern of change in oculomotor function and visual scanning behaviour (VSB) in the participants over a 6-month period.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants (age group 18-60) who present to the emergency department in the University Health Network within 7 days of concussion

排除标准

  • Age less than 18
  • Any other neurological disorder (e.g. seizures)
  • Any systemic illness known to affect the brain (e.g. diabetes and lupus)
  • History of major psychiatric disorder (e.g. bipolar, schizophrenia)
  • History of known developmental disorders (e.g. attention deficit disorder, dyslexia)
  • Any lesion detected by MRI prior to the study
  • Any previous vision disorder that prevents the participant from performing the self-paced saccade task
  • Any brain injury more severe than concussion
  • Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
  • Healthy Controls:
  • Inclusion Criteria:
  • Participants (age group 18-60) with no previous history of concussions who are age, education and sex-matched to the patients' group will be recruited from the community.
  • Exclusion Criteria:
  • All exclusion criteria mentioned above for patients plus any history of concussions

结局指标

主要结局

self-paced saccade

时间窗: 2 years

Number of self paced saccadic eye movements in 60 seconds

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carmela Tartaglia

Marion and Gerald Soloway Chair in Brain Injury and Concussion Research Associate Professor, University of Toronto

University Health Network, Toronto

研究点 (1)

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