NCT05551520

Brief Summary

This research study is designed to establish normative database and reliability of ImPACT for adolescents and adults ages 12 through 80 to expand the use of devices to include touchscreen.

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
1,437

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 7, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

March 29, 2022

Last Update Submit

July 3, 2023

Conditions

Concussion

Keywords

Brain

Outcome Measures

Primary Outcomes (1)

  • Validity

    ImPACT Touchscreen performs within normal parameters of ImPACT Online

    12 months

Secondary Outcomes (1)

  • Reliability

    Baseline test will be administered at enrollment and re-test will be administered within 60 days of baseline test.

Study Arms (2)

Normative

OTHER

ImPACT will be administered to participant's for a baseline test.

Device: Normative

Reliability

OTHER

ImPACT will be administered to participant's within 60 days of baseline test.

Device: Reliability

Interventions

NormativeDEVICE

ImPACT will be administered at baseline testing

Normative
ReliabilityDEVICE

ImPACT will be administered again within 60 days of baseline test

Reliability

Eligibility Criteria

Age12 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age 12-80
  • Primary English speaking or fluent in English

You may not qualify if:

  • Documentation of a known special education diagnosis other than a 504 designation.
  • History of concussion less than 6 months to the study participation
  • Known physical (e.g., visual impairment not fixable by usual means, such as glasses) or psychological impairment (ADHD, LDD, etc.) that would affect their ability to perform the test.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ImPACT Applications, Inc.

Coralville, Iowa, 52241, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Reproducibility of Results

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesEvaluation Studies as TopicHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

March 29, 2022

First Posted

September 22, 2022

Study Start

February 7, 2022

Primary Completion

June 1, 2024

Study Completion

October 1, 2024

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

US(1)