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临床试验/NCT06266234
NCT06266234招募中不适用

Characterization by Automated System on Infantile Spasmes

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
5,000
试验地点
1
主要终点
Automated computer detection of the spasms > 95%

研究概览

简要总结

Infantile spasms are defined by the occurrence of epileptic episodes characterized by the appearance of very specific motor seizures, made up of rapid, repeated contractions in flexion or extension known as spasms. This syndrome is of high concern as it will lead to mental retardation if it is not early identified and treated. Most often, spasms are characterized by sudden contractions of the body in flexion. More rarely, spasms occur in extension: the neck and legs suddenly tense, and the arms move upwards or sideways. Spasms may be accompanied by eye revulsion. They are brief, lasting 0.5 to 2 seconds each. At the start of the attack, they may be isolated, but then may occur in series lasting up to several tens of minutes.

Because of its nature and duration, infantile spasm is often difficult to identify and is often confused with benign motor manifestations in children, such as hiccups or muscular jerks. This difficulty often leads to delays in diagnosis. Indeed, patients are often seen at the stage when cognitive regression has set in.

The gold standard for diagnosing infantile spasms is to capture them on video-EEG to confirm the ictal correlate of the seizure. Although multiple variations are known, the ictal correlation is often a diffuse slow wave of high amplitude with subsequent electrodecrement. Yet continuous video electroencephalogram is an expensive and time-consuming resource often unavailable in developing countries and in many parts of the developed world. Furthermore, in an appropriate clinical scenario, continuous video-EEG may be unnecessary. For example, a home video examination with typical spasms combined with a definitively epileptic ambulatory EEG may certainly be adequate for the diagnosis of infantile spasms

As part of Mr. Diop's thesis, the study team have developed a system for analyzing videos acquired in 2 dimensions from a simple smartphone or webcam and highlighting the existence of spasms in a child. The principle is to use computer vision and computer learning model to identify the spasms from these videos. The first prototype of this system achieved a positive predictive value of 77%, which is very good considering the small sample used (< 100) but quite insufficient to obtain a diagnostic prediction for medical use, for which we hope for sensitivity and specificity of around 95%.

The aim is to achieve a sensitivity and specificity of over 95% so that we can offer this detection system to healthcare professionals and parents of children who do not have rapid access to diagnosis. The aim is to develop a system enabling broad screening at the population level so that identified children can be more rapidly directed towards the healthcare system and appropriate treatment for their disease.

To achieve this goal, we need access to a standardized reference database that currently exists in the various pediatric electrophysiology laboratories of the Assistance Publique - Hôpitaux de Paris and the Île-de-France region. we propose using the films stored in these laboratories to teach the computer to recognize spasms that have already been formally identified by electrophysiologists and by ictal concordance.

详细描述

There is insufficient evidence to determine whether other forms of corticosteroids are as effective as adrenocorticotropic hormone (ACTH) for the short-term treatment of infantile spasms. However, low-dose ACTH is probably as effective as high-dose ACTH. ACTH is more effective than vigabatrin (VGB) for the short-term treatment of children with infantile spasms (with the exception of those with tuberous sclerosis complex). There is insufficient evidence to show that other agents and combination therapy are effective for the short-term treatment of infantile spasms. A short time to treatment leads to a better long-term developmental outcome. Successful short-term treatment of cryptogenic infantile spasms with ACTH or prednisolone leads to better long-term developmental outcomes than treatment with VGB.

Current recommendations are that a low dose of ACTH should be considered for the treatment of infantile spasms. ACTH or VGB may be useful for short-term treatment of infantile spasms, with ACTH preferred to VGB. Hormone therapy (ACTH or prednisolone) may be considered in preference to VGB in infants with cryptogenic infantile spasms to improve developmental outcomes potentially. A shorter delay before treating infantile spasms with hormone therapy or VGB may improve long-term developmental outcomes.

In summary, the management of infantile spasms presents several issues. Diagnosis is often delayed due to the particular symptomatology and difficulty accessing diagnostic means: specialized consultation and video EEG. This delay represents a loss of opportunity for patients, as appropriate treatment may be delayed. There is still disagreement between clinicians on the characterization of infantile spasms, with little agreement, particularly at the level of electroencephalographic analysis.

The aim of this science thesis is to identify infantile spasms using simple video analysis, enabling a monitoring routine to be set up at home or using a smartphone. Initially, luminance analysis is used to estimate the amount of movement.

Computer vision systems for medical diagnosis are undergoing exponential development thanks to recent advances in computer science and automated learning. We are using classic techniques in this field to diagnose spasms in children. To obtain consistent results, we need to start from the gold standard today, the video electroencephalogram acquired in the neurophysiology laboratory.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
— 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients who presented with spasm and had a video EEG recording in one of the participating centers
  • Social security affiliation
  • Legal tutor autorisation.

排除标准

  • 未提供

结局指标

主要结局

Automated computer detection of the spasms > 95%

时间窗: at 2 years

次要结局

  • Automated computer detection of the non spasms > 95%(at 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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