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Infantile SpasmREASSESSNCT06266234

Characterization by Automated System on Infantile Spasmes

An observational study of Infantile Spasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 3 years
Conditions the study is for
Infantile Spasm
How many people
5,000 participants
Where
1 siteFrance
Study dates
1 Feb 2024to Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Infantil patients with spasm and had a video EEG recording in one of the participating centers.

Who may be able to join

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

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Department of paediatric neurological care and intensive care unity (PICU), Raymond Poincaré hospital - APHP

    Garches, 92380

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the 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 - vincente.lecomte@aphp.fr ]

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 and/or 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 spasm(s) 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 system's 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.

Conditions
Infantile Spasm
Keywords
infantile Spasm, epilepsy, neurology, neurological disease
Medical subject headings
Spasms, Infantile, Epilepsy, Nervous System Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Automated computer detection of the spasms > 95%

    Measured: at 2 years

Secondary outcomes (1)
  1. Automated computer detection of the non spasms > 95%

    Measured: at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
5,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06266234
Sponsor's protocol ID
APHP230600
Other IDs
10723253 Bis
Acronym
REASSESS
Status last verified
Jan 2025
First submitted
29 Jan 2024
Last updated
11 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Infantile Spasm, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Samuel Diop, PhD (+ 33 1 47 10 79 00, snfdiop@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Automated computer detection of the spasms > 95% (time frame: at 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.

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