ImPACT Normative Extension

NCT ID: NCT03180905

Last Updated: 2023-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Concussion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Validity

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

Group Type EXPERIMENTAL

ImPACT Online/Paper Pencil Tests

Intervention Type DEVICE

Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests

Test/Re-Test

ImPACT Online will be administered at 2 time points

Group Type ACTIVE_COMPARATOR

ImPACT Online

Intervention Type DEVICE

ImPACT Online will be administered at 2 time points.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ImPACT Online/Paper Pencil Tests

Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests

Intervention Type DEVICE

ImPACT Online

ImPACT Online will be administered at 2 time points.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ImPACT Applications, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Comprehensive Med Psych Systems, Inc.

Sarasota, Florida, United States

Site Status COMPLETED

University of Albany

Albany, New York, United States

Site Status COMPLETED

ImPACT Applications Inc.

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jane Luce

Role: CONTACT

412-567-8400 ext. 938

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jane Luce

Role: primary

412-567-8400 ext. 938

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QPR-17-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Attention Intervention Management
NCT01779427 WITHDRAWN NA
Recent Experiences With Concussions
NCT02626650 WITHDRAWN NA