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ImPACT Normative Extension

Primary Purpose

Brain Concussion

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ImPACT Online/Paper Pencil Tests
ImPACT Online
Sponsored by
ImPACT Applications, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Brain Concussion

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Comprehensive Med Psych Systems, Inc.
  • University of Albany
  • ImPACT Applications Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Validity

Test/Re-Test

Arm Description

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

ImPACT Online will be administered at 2 time points

Outcomes

Primary Outcome Measures

Validity
ImPACT Online compared to Brief Visuospatial Memory Test
Validity
ImPACT Online compared to Symbol Digit Modalities Test
Validity
ImPACT Online compared to Color Trails
Validity
ImPACT Online compared to Hopkins Verbal Learning Test.

Secondary Outcome Measures

Reliability
Reliability will be established through a test/re-test. Online ImPACT will be administered at 2 time points to establish results should be stable over time.

Full Information

First Posted
May 23, 2017
Last Updated
September 27, 2023
Sponsor
ImPACT Applications, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03180905
Brief Title
ImPACT Normative Extension
Official Title
ImPACT Normative Extension
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ImPACT Applications, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Concussion

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Validity
Arm Type
Experimental
Arm Description
ImPACT Online a computerized test will be administered to subjects. They will also receive a battery of paper and pencil neuropsychological tests.
Arm Title
Test/Re-Test
Arm Type
Active Comparator
Arm Description
ImPACT Online will be administered at 2 time points
Intervention Type
Device
Intervention Name(s)
ImPACT Online/Paper Pencil Tests
Intervention Description
Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests
Intervention Type
Device
Intervention Name(s)
ImPACT Online
Intervention Description
ImPACT Online will be administered at 2 time points.
Primary Outcome Measure Information:
Title
Validity
Description
ImPACT Online compared to Brief Visuospatial Memory Test
Time Frame
12 Months
Title
Validity
Description
ImPACT Online compared to Symbol Digit Modalities Test
Time Frame
12 Months
Title
Validity
Description
ImPACT Online compared to Color Trails
Time Frame
12 Months
Title
Validity
Description
ImPACT Online compared to Hopkins Verbal Learning Test.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Reliability
Description
Reliability will be established through a test/re-test. Online ImPACT will be administered at 2 time points to establish results should be stable over time.
Time Frame
Baseline Test will be administered at enrollment and re- test will be administered within 30 days of baseline test.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jane Luce
Phone
412-567-8400
Ext
938
Email
jluce@impacttest.com
Facility Information:
Facility Name
Comprehensive Med Psych Systems, Inc.
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Individual Site Status
Completed
Facility Name
University of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12222
Country
United States
Individual Site Status
Completed
Facility Name
ImPACT Applications Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jane Luce
Phone
412-567-8400
Ext
938
Email
jluce@impacttest.com

12. IPD Sharing Statement

Plan to Share IPD
No

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ImPACT Normative Extension

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