NCT03180905

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

7.7 years

First QC Date

May 23, 2017

Last Update Submit

September 27, 2023

Conditions

Brain Concussion

Outcome Measures

Primary Outcomes (4)

  • Validity

    ImPACT Online compared to Brief Visuospatial Memory Test

    12 Months

  • Validity

    ImPACT Online compared to Symbol Digit Modalities Test

    12 Months

  • Validity

    ImPACT Online compared to Color Trails

    12 Months

  • Validity

    ImPACT Online compared to Hopkins Verbal Learning Test.

    12 Months

Secondary Outcomes (1)

  • Reliability

    Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.

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

ImPACT Online/Paper Pencil TestsDEVICE

Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests

Validity
ImPACT OnlineDEVICE

ImPACT Online will be administered at 2 time points.

Test/Re-Test

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 60-80
  • Primary English speaking or fluent in English.
  • Currently does not reside in a skilled nursing facility.
  • Currently not suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
  • No known physical, neurological, behavioral or psychological impairment that would affect their ability to perform the test.
  • Hearing or vision impairments that have not been corrected within normal limits.
  • A score of 24 or greater on the MMSE (Mini-Mental State Examination).

You may not qualify if:

  • English is not their primary language nor are they proficient in the English language.
  • Currently resides in a skilled nursing facility.
  • Currently suffering from a concussion or being treated for a concussion, unless enrolled in the subgroup Discriminative Validity.
  • Known physical, neurological, behavioral, or psychological impairment that would affect their ability to take or complete the test.
  • Hearing or vision impairments that would affect their ability to perform the test.
  • Score of 23 or below on the MMSE(Mini-Mental State Examination).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Comprehensive Med Psych Systems, Inc.

Sarasota, Florida, 34236, United States

COMPLETED

University of Albany

Albany, New York, 12222, United States

COMPLETED

ImPACT Applications Inc.

Pittsburgh, Pennsylvania, 15228, United States

RECRUITING

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

Central Study Contacts

Jane Luce

CONTACT

412-567-8400jluce@impacttest.com

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

May 23, 2017

First Posted

June 8, 2017

Study Start

May 1, 2017

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)