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Digital biomarkers

A technology of data and parameters, applied in the field of diagnostic devices for the severity and progress of symptoms, which can solve the problems of inconvenient and high cost

Pending Publication Date: 2022-04-15
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] Participant Analysis: 20

[0090] Data Analysis Period: 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 females, 11 males

[0092] ii) JEWELFISH study

[0093] (https: / / clinicaltrials.gov / ct2 / show / NCT03032172?term=BP39054)

[0094] Participant Analysis: 19

[0095]

[0096]

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PUM

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Abstract

Currently, assessing the severity and progression of symptoms in a subject diagnosed with muscle dysfunction, in particular SMA, involves clinical monitoring and testing of the subject every 6 to 12 months. However, more frequent monitoring and testing of the subject is preferred, but increasing the frequency of clinical monitoring and testing may be expensive and not very convenient for the subject. Thus, as described herein, the severity and progression of symptoms are assessed via remote monitoring and testing of the subject outside the clinical environment, providing advantages in terms of cost, ease of monitoring, and convenience for the subject. Systems, methods, and devices according to the present disclosure provide a diagnostic for assessing distal hypomyotonia in a subject suffering from muscle dysfunction, particularly SMA, based on active testing of the subject.

Description

technical field [0001] The present invention relates to a medical device for improving subject testing and subject analysis. More specifically, aspects described herein provide a diagnostic device for assessing muscle disability, in particular the severity and progression of symptoms of spinal muscular atrophy (SMA) in a subject, by active testing on the subject, systems and methods. Background technique [0002] Spinal muscular atrophy (SMA) is an autosomal recessive genetic disease, also known as proximal spinal muscular atrophy and 5q type spinal muscular atrophy. It is a life-threatening neuromuscular disorder with low incidence associated with loss of motor neurons and progressive muscle wasting. [0003] SMA has become a health problem and a significant economic burden on the health system. As SMA is a clinically heterogeneous disease of the CNS, diagnostic tools are needed to reliably diagnose and identify current disease state and symptom progression, thereby faci...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G16H50/20A61B5/00
CPCG16H50/20A61B5/7275A61B5/7264A61B5/1125A61B5/225A61B2505/07A61B2562/0219A61B5/6898A61B5/4082A61B5/407G16H40/63A61B5/0004A61B5/4842
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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