NCT06266234 Characterization by Automated System on Infantile Spasmes
| NCT ID | NCT06266234 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Infantile Spasm |
| Study Type | OBSERVATIONAL |
| Enrollment | 5,000 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 5,000 participants in total. It began in 2024-02-01 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * Patients who presented with spasm and had a video EEG recording in one of the participating centers * Social security affiliation * Legal tutor autorisation. Exclusion Criteria: \-
Contact & Investigator
Jean Bergounioux, MD, PhD
PRINCIPAL INVESTIGATOR
Department of paediatric neurological care and intensive care unity, Raymond Poincaré hospital - APHP
Frequently Asked Questions
Who can join the NCT06266234 clinical trial?
This trial is open to participants of all sexes, up to 3 Years, studying Infantile Spasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06266234 currently recruiting?
Yes, NCT06266234 is actively recruiting participants. Contact the research team at snfdiop@outlook.com for enrollment information.
Where is the NCT06266234 trial being conducted?
This trial is being conducted at Garches, France.
Who is sponsoring the NCT06266234 clinical trial?
NCT06266234 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Jean Bergounioux, MD, PhD at Department of paediatric neurological care and intensive care unity, Raymond Poincaré hospital - APHP. The trial plans to enroll 5,000 participants.