Development of a Neurocognitive Screening Test

ImPACT Applications

Status: Terminated

Conditions: Mild Cognitive Impairment; Brain Concussion

Treatments: Device: Quick Test; Other: Pen and paper neuropsychological test

Study type: Interventional

Funder types: Industry

Identifiers

NCT02597504

QPR-15-44

Details and patient eligibility

About

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.

Enrollment: 1,600 patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,600 participants in 2 patient groups

Standardization

Active Comparator group

Description:

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

Treatment:

Device: Quick Test

Validity and Reliability

Experimental group

Description:

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.

Treatment:

Other: Pen and paper neuropsychological test

Device: Quick Test