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Clinical Trials/NCT02597504
NCT02597504
Terminated
Not Applicable

Development of a Neurocognitive Screening Test

ImPACT Applications, Inc.4 sites in 1 country1,600 target enrollmentOctober 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Concussion
Sponsor
ImPACT Applications, Inc.
Enrollment
1600
Locations
4
Primary Endpoint
Reliability will be established through a test-retest to establish results should be stable over time
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
October 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

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

Time Frame: 12 Months

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

Time Frame: 12 Months

Study Sites (4)

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