Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06266234
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2024-01-29
Brief Title:
Characterization by Automated System on Infantile Spasmes
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Characterization by Automated System on Infantile Spasmes
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REASSESS
Brief Summary:
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 05 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 Diops 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
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 Diops 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
Detailed Description:
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
Therefore 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
Organisation and security
This work aims to enable spasms to be recognized reliably by an automated system making it possible to direct children more rapidly towards appropriate and effective disease management
Funder same as data controller
Data Protection Officer Ms Vincente lecomte Data Protection Officer AP-HP Université Paris Saclay Hôpitaux Antoine-Béclère - Maritime de Berck Bicêtre - Paul-Brousse - Ambroise-Paré Sainte-Périne - Raymond-Poincaré - vincentelecomteaphpfr
The centers participating in the project are the Neurophysiology laboratories of the APHP teaching hospitals Hôpital Kremlin Bicêtre Hôpital Raymond Poincaré Hôpital Necker Hôpital Trousseau Hôpital Robert Debré and that of the Fondation Adolphe de Rothschild
The aim of the project is to develop a system for detecting spasm-type seizures in children The aim is to achieve a level of sensitivity and specificity that will enable it to be used as a tool for early detection of seizures and as a monitoring tool for the general public and healthcare professionals using consumer video acquisition systems smartphones webcams etc
The benefits of the project are twofold The benefits are twofold It should enable patients to gain earlier access to specialized care thanks to the earlier identification or suspicion of the disease through the use of a smartphone or webcam It should enable patients undergoing treatment to be monitored and the therapies used to treat them to be assessed
Transparency and publication of results the results obtained will be published in a peer-reviewed journal
Measures taken to scientific integrity and quality of the studies the methodology methodology adopted is a learning process on part of the cohort and a randomized sample of patients Part of the database obtained from the various centers will be used for machine machine learning A sample of this same database andor a naive sample sample will be selected to test the performance of the detection system
The patients included are pediatric patients who have undergone video EEG in one of the electrophysiology centers of ile-de-France Patients diagnosed as having spasms will be included as well as patients with other types of epilepsy
The aim is to be able to detect spasms as they occur The patient is his or her own witness In fact spasms are discrete manifestations occurring against a background of normal activity The background of activity represents the true negative and the spasms presented by the patient the true positive Obtaining examinations of other types of seizure will enable us to refine the search for and identification of spasms by checking whether the system in place is capable of differentiating spasms from other types of seizure
The study is based on retrospective data The aim is to demonstrate the systems proof-of-concept before attempting to set up a prospective study The aim of this request is to be authorized to use the films coupled with electroencephalograms acquired in the various electrophysiology centers in the Ile-de-France region Assistance Publique - Hôpitaux de Paris and Fondation Rothschild so as to be able to implement machine learning on the analysis of the videos Indeed in this type of project we need to be able to compare ourselves with the reference examination which today is the electroencephalogram coupled with a video
The various laboratories keep a collection of films of children with epileptic spasms coupled with electroencephalograms which make it possible to characterize the spasm as epileptic with relative certainty These films have already been screened by neurophysiologists and are therefore of the highest quality Each film may contain several spasms each of which represents a different event enabling the system to learn to recognize a spasm
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
Therefore 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
Organisation and security
This work aims to enable spasms to be recognized reliably by an automated system making it possible to direct children more rapidly towards appropriate and effective disease management
Funder same as data controller
Data Protection Officer Ms Vincente lecomte Data Protection Officer AP-HP Université Paris Saclay Hôpitaux Antoine-Béclère - Maritime de Berck Bicêtre - Paul-Brousse - Ambroise-Paré Sainte-Périne - Raymond-Poincaré - vincentelecomteaphpfr
The centers participating in the project are the Neurophysiology laboratories of the APHP teaching hospitals Hôpital Kremlin Bicêtre Hôpital Raymond Poincaré Hôpital Necker Hôpital Trousseau Hôpital Robert Debré and that of the Fondation Adolphe de Rothschild
The aim of the project is to develop a system for detecting spasm-type seizures in children The aim is to achieve a level of sensitivity and specificity that will enable it to be used as a tool for early detection of seizures and as a monitoring tool for the general public and healthcare professionals using consumer video acquisition systems smartphones webcams etc
The benefits of the project are twofold The benefits are twofold It should enable patients to gain earlier access to specialized care thanks to the earlier identification or suspicion of the disease through the use of a smartphone or webcam It should enable patients undergoing treatment to be monitored and the therapies used to treat them to be assessed
Transparency and publication of results the results obtained will be published in a peer-reviewed journal
Measures taken to scientific integrity and quality of the studies the methodology methodology adopted is a learning process on part of the cohort and a randomized sample of patients Part of the database obtained from the various centers will be used for machine machine learning A sample of this same database andor a naive sample sample will be selected to test the performance of the detection system
The patients included are pediatric patients who have undergone video EEG in one of the electrophysiology centers of ile-de-France Patients diagnosed as having spasms will be included as well as patients with other types of epilepsy
The aim is to be able to detect spasms as they occur The patient is his or her own witness In fact spasms are discrete manifestations occurring against a background of normal activity The background of activity represents the true negative and the spasms presented by the patient the true positive Obtaining examinations of other types of seizure will enable us to refine the search for and identification of spasms by checking whether the system in place is capable of differentiating spasms from other types of seizure
The study is based on retrospective data The aim is to demonstrate the systems proof-of-concept before attempting to set up a prospective study The aim of this request is to be authorized to use the films coupled with electroencephalograms acquired in the various electrophysiology centers in the Ile-de-France region Assistance Publique - Hôpitaux de Paris and Fondation Rothschild so as to be able to implement machine learning on the analysis of the videos Indeed in this type of project we need to be able to compare ourselves with the reference examination which today is the electroencephalogram coupled with a video
The various laboratories keep a collection of films of children with epileptic spasms coupled with electroencephalograms which make it possible to characterize the spasm as epileptic with relative certainty These films have already been screened by neurophysiologists and are therefore of the highest quality Each film may contain several spasms each of which represents a different event enabling the system to learn to recognize a spasm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10723253 Bis | OTHER | CESREES | None |