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临床试验/NCT02597504
NCT02597504终止不适用

Development of a Neurocognitive Screening Test

ImPACT Applications, Inc.4 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1,600
试验地点
4
主要终点
Reliability will be established through a test-retest to establish results should be stable over time

研究概览

简要总结

This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.

The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
6 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Age: 12-75 (Adult version), 6-11 (pediatric version)
  • •Primary English speaking or fluent in English.
  • •No known special education diagnosis excluding a 504 designation.
  • •Currently not suffering from a concussion or being treated for a concussion.*
  • •No known physical or psychological impairment that would affect their ability to perform the test.

排除标准

  • •Documentation of a known special education diagnosis other than a 504 designation.
  • •English is not their primary language nor are they proficient in the English language.
  • •Currently suffering from a concussion or being treated for a concussion.*
  • •Any known physical or psychological impairment that would affect their ability to perform the test.
  • •Note: Unless specifically required by the particular study (i.e., a discriminant validity study differentiating concussed versus non-concussed individuals).

研究组 & 干预措施

Standardization

Active Comparator

individuals assigned to this group will be healthy volunteers and will take the Quick Test.

干预措施: Quick Test (Device)

Validity and Reliability

Experimental

Reliability:

Test-Retest

Validity:

Concurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test.

干预措施: Pen and paper neuropsychological test (Other)

Validity and Reliability

Experimental

Reliability:

Test-Retest

Validity:

Concurrent:Quick Test administered with ImPACT online Discriminant: Concussed patient administered Quick Test Construct: Determine agreement between Quick Test and and paper and pencil test.

干预措施: Quick Test (Device)

结局指标

主要结局

Reliability will be established through a test-retest to establish results should be stable over time

时间窗: 12 Months

Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.

时间窗: 12 Months

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (4)

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