Digital biomarker
A data, parametric technology, applied in the field of diagnostic devices for symptom severity and progression, which can solve the problems of inconvenient and high cost
Pending Publication Date: 2022-01-14
F HOFFMANN LA ROCHE & CO AG
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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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example 1
[0086] Characteristics of the analyzed patient cohort collected in two different studies.
[0087] i) OLEOS Study (https: / / clinicaltrials.gov / ct2 / show / NCT02628743)
[0088] Participants analyzed: 20
[0089] Data Analysis Period: Smartphone data between the last two clinical visits (176 days)
[0090] Mean (SD) scope age 12.4(4.1)[years old] 8.0 to 22.0 gender 9 women, 11 men
[0091] ii) JEWELFISH study
[0092] (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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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 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 for assessing the severity and progression of muscle incapacity, in particular symptoms of spinal muscular atrophy (SMA), in a subject by active testing of the subject and methods. 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 incidence associated with loss of motor neurons and progressive muscle wasting. [0003] SMA has become a health problem and is also 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, which can f...
Claims
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IPC IPC(8): G16H50/20A61B5/00
CPCG16H50/20A61B2505/07A61B2562/0219A61B5/6898A61B5/1125A61B5/225A61B5/4082A61B5/407A61B5/7275G16H40/63G16H20/30G16H50/30G16H20/10A61B5/1126A61B5/224A61K31/519
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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