NCT02597504

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
terminated

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

October 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 5, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

4 years

First QC Date

October 16, 2015

Last Update Submit

September 27, 2023

Conditions

Brain ConcussionMild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

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

    12 Months

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

    12 Months

Study Arms (2)

Standardization

ACTIVE COMPARATOR

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

Device: Quick Test

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.

Other: Pen and paper neuropsychological testDevice: Quick Test

Interventions

Pen and paper neuropsychological testOTHER

Will be administered for Construct Validity to determine agreement with Quick Test

Validity and Reliability
Quick TestDEVICE

Quick Test, computerized test will be administered to all subjects.

StandardizationValidity and Reliability

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.\*
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

FastMed Urgent Care

Scottsdale, Arizona, 85254, United States

Location

University of Arkansas

Fayetteville, Arkansas, 72701, United States

Location

Head First

Crofton, Maryland, 21114, United States

Location

Jim Gyurke

Pittsburgh, Pennsylvania, 15288, United States

Location

MeSH Terms

Conditions

Brain ConcussionCognitive Dysfunction

Interventions

penclomedineProthrombin Time

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, NonpenetratingCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

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

Study Record Dates

First Submitted

October 16, 2015

First Posted

November 5, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations

US(4)