NCT02701842

Brief Summary

The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

February 27, 2016

Last Update Submit

August 22, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

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

    12 Months

  • Reliability will be established through a test/re-test to establish results should be stable over time.

    12 Months

Study Arms (2)

Validity

EXPERIMENTAL

ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.

Device: ImPACT Online/Paper Pencil Tests

Test/Re-Test

ACTIVE COMPARATOR

ImPACT Online will be administered at 2 time points.

Device: ImPACT Online

Interventions

Test/Re-Test

Eligibility Criteria

Age12 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age: 12-59
  • 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.
  • An average or above average score on the RIST (Reynolds Intellectual Screening Test).

You may not qualify if:

  • 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.
  • A below average score on the RIST.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ImPACT Applications Inc.

Pittsburgh, Pennsylvania, 15228, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2016

First Posted

March 8, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

August 23, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations