Digital biomarkers for progressing ms

A dataset, secondary technique, applied in the field of diagnostics

Pending Publication Date: 2019-04-26
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, none of the aforementioned techniques are MS-specific

Method used

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  • Digital biomarkers for progressing ms
  • Digital biomarkers for progressing ms
  • Digital biomarkers for progressing ms

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0386] Example 1: Computer-implemented (electronic) Symbolic Digital Modal Testing (eSDMT)

[0387] A smartphone with a 5.1-inch screen is programmed with the kit for performing the eSDMT test. The tester is asked to perform the test on the smartphone according to the instructions shown on the display. 30 subjects were investigated. The determined response and accuracy are shown in the Figure 5 middle.

[0388] The time elapsed between subsequent response (R) and subsequent correct response (CR) was also investigated in the implemented eSDMT test. The results are shown in Figure 6 middle.

[0389] In addition, response (R) and correct response (CR) profiles were determined. Examples of Response (R) and Correct Response (CR) profiles of two subjects with distinctly different performances on the eSDMT test are shown in Figure 7 middle.

example 2

[0390] Example 2: Computer-implemented test to assess fine motor skills (fine motor assessment), particularly hand motor function, and specifically the touchscreen-based "draw shape" and "squeeze shape" tests

[0391] A smartphone with a 5.1-inch screen was programmed with a suite for performing the "draw shape" and "squeeze shape" tests. The tester is asked to perform the test on the smartphone according to the instructions shown on the display.

[0392] In the pinch shape setup, touch events from the first and second fingers are determined and the distance and velocity of the pinch events are calculated ( Figure 8 ). In the drawing shape setting, a circle-shaped touch trace is defined. The results are plotted in Figure 9 or Figure 11 middle.

[0393] The overall calculated trace performance is shown separately in Figure 10 and Figure 12 , and detailed data are summarized in Table 1 or Table 2 below.

[0394] Table 1: Circle evaluation readout performance statist...

example 3

[0399] Example 3: Results from a prospective pilot study (FLOODLIGHT) to evaluate the feasibility of using digital technologies for remote patient monitoring in patients with multiple sclerosis

[0400] Study populations will be selected by using the following inclusion and exclusion criteria:

[0401] Key inclusion criteria:

[0402] Sign the informed consent

[0403] Able to comply with the study protocol, in the investigator's judgment

[0404] Age 18-55, including 18 and 55

[0405] Diagnosed with MS, confirmed according to revised McDonald 2010 guidelines

[0406] EDSS score from 0.0 to 5.5 inclusive

[0407] Weight: 45-110kg

[0408] For women of reproductive potential: Agree to use an acceptable method of contraception during the study period

[0409] Key strikeout guidelines:

[0410] Patients who, in the judgment of the investigator, are seriously ill and unstable

[0411] Change dosing regimen or switch disease-modifying therapy (DMT) within the last 12 weeks...

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Abstract

The present invention relates to the field of diagnostics. Specifically, the invention relates to a method of identifying progressing multiple sclerosis (MS) in a subject, and the method includes thesteps of determining at least one performance parameter determined from a dataset of activity measurements obtained from said subject using a mobile device, and comparing the determined at least one performance parameter to a reference, whereby a subject with progressing MS will be identified. Moreover, encompassed by the present invention is a method of recommending an anti-CD20 antibody therapyagainst MS comprising the steps of the method of the present invention and the further step of recommending the anti-CD20 antibody therapy if the subject suffers from progressing MS. The present invention also relates to a mobile device comprising a processor, at least one sensor and a database as well as software which is tangibly embedded to said device and, when running on said device, carriesout the method, and to the use of such a device for identifying a subject suffering from progressing MS.

Description

technical field [0001] The present invention relates to the field of diagnostics. In particular, the present invention relates to a method of identifying progressive multiple sclerosis (MS) in a subject, comprising the steps of: determining the at least one performance parameter; and comparing the determined at least one performance parameter to a reference value whereby a subject with progressive MS will be identified. Furthermore, encompassed by the invention is a method of recommending anti-CD20 antibody therapy for MS comprising the steps of the method of the invention and recommending said anti-CD20 antibody therapy if said subject suffers from progressive MS further steps. The invention also relates to a mobile device comprising a processor, at least one sensor and a database, and software tangibly embedded in said device and which, when run on said device, performs the method of the invention, and relates to the use of such a device to identify subjects with progress...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H50/20
CPCG16H50/20G16H10/20
Inventor M.巴克S.M.贝拉切夫C.戈森斯M.林德曼
Owner F HOFFMANN LA ROCHE & CO AG
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