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Digital biomarker

A technology of data and parameters, applied in the field of diagnostic devices for symptom severity and progression, which can solve the problems of high cost, increased frequency of clinical monitoring and testing, and inconvenience

Pending Publication Date: 2022-02-01
F HOFFMANN LA ROCHE & CO AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

While it would be ideal to monitor and test subjects more frequently, increasing the frequency of clinical monitoring and testing can be costly and inconvenient for subjects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0087] Characteristics of the analyzed patient cohort collected in two different studies.

[0088] i) OLEOS Study (https: / / clinicaltrials.gov / ct2 / show / NCT02628743)

[0089] Participants analyzed: 20

[0090] Time period for data analysis: Smartphone data between the last two clinical visits (176 days)

[0091] Mean (SD) scope age 12.4(4.1)[years old] 8.0 to 22.0 gender 9 women, 11 men

[0092] ii) JEWELFISH Study (https: / / clinicaltrials.gov / ct2 / show / NCT03032172?term=BP39054)

[0093] Participants analyzed: 19

[0094] Mean (SD) scope age 23.2 (17.2) [years old] 6.0 to 60.0 gender 6 women, 13 men

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PUM

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Abstract

Currently, assessing the severity and progression of symptoms in a subject diagnosed with a muscular disability, in particular SMA involves in-clinic monitoring and testing of the subject every 6 to 12 months. However, monitoring and testing a subject more frequently is preferred, but increasing the frequency of in-clinic monitoring and testing can be costly and inconvenient to the subject. Thus, assessing the severity and progression of symptoms via remote monitoring and testing of the subject outside of a clinic environment as described herein provides advantages in cost, ease of monitoring and convenience to the subject. Systems, methods and devices according to the present disclosure provide a diagnostic for assessing of the axial motor function of a subject having a muscular disability, in particular SMA by active testing of the subject.

Description

technical field [0001] The present invention relates to a medical device for improved subject testing and subject analysis. More specifically, aspects described herein provide diagnostic devices, systems, and diagnostic devices for assessing the severity and progression of symptoms of muscle incapacity, particularly spinal muscular atrophy (SMA), in a subject through active testing by the subject. method. Background technique [0002] Spinal muscular atrophy (SMA) is an autosomal recessive genetic disorder also known as proximal spinal muscular atrophy and 5q spinal muscular atrophy. It is a life-threatening neuromuscular disorder with low prevalence associated with loss of motor neurons and progressive muscle wasting. [0003] SMA has become a health problem and places a heavy financial burden on the healthcare system. As SMA is a clinically heterogeneous disease of the CNS, there is a need for diagnostic tools that allow reliable diagnosis and identification of current ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61B5/00A61B5/11
CPCA61B5/4519A61B5/11G16H50/20G16H20/30A61B5/4566A61B5/1124A61B5/1126A61B5/6898G16H40/63A61B5/0022A61B5/4538A61B5/4839A61B5/7275
Inventor C·戈森斯M·林德曼F·利普斯梅尔D·沃尔夫
Owner F HOFFMANN LA ROCHE & CO AG
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