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| Name | Class |
|---|---|
| Research America Inc. | INDUSTRY |
| Qserve | INDUSTRY |
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This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include ages 18-49 and 80+ and aims to validate two new digital tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A1 (Norms + Validation, 18-49 years) + Group A2 (Validation, 50+ years) | Other | Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using paper-pencil tests. |
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| Group B (Validation, 18+) | Other | Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using digital tests. |
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| Group C1 (Norms + Validation, 18-49 years) + Group C2 (Validation, 50+ years) | Other | Visit 1: Participants' cognition is measured using digital tests. Visit 2: Participants' cognition is measured using digital tests. |
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| Group D (Validation, 18+) | Other | Visit 1: Participants' cognition is measured using paper-pencil tests. Visit 2: Participants' cognition is measured using paper-pencil tests. |
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| Group E (Norms, 18-49 years) | Other | Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips IntelliSpace Cognition (ISC). | Device | Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices. |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Scores digital (ISC) tests [Time Frame: 1.5 hours]. Scores retrieved from all cognitive tests on the ISC platform. | 1.5 hours | |
| or 1.5 hours]. Scores retrieved from Symbol Digit Modalities Test (SDMT) + Naming Test (NT) or all paper-based cognitive tests | 0.75 h or 1.5 hours |
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Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research America Inc. | Newtown Square | Pennsylvania | 19073 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2023 | Mar 21, 2023 | 3 | ||
| Mar 31, 2023 |
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| Group F (Norms, 80-95 years) | Other | Visit 1: Participants' cognition is measured using digital tests. Visit 2: N/A |
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| Paper-Pencil Tests. | Diagnostic Test | The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice. |
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| Apr 21, 2023 |
| 4 |
| Apr 25, 2023 | May 19, 2023 | 5 |
| May 26, 2023 | Jun 21, 2023 | 6 |