Clinical trial NCT05959746: Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage1- Collection of Video-clinical Data in a Pragmatic Situation.
Official title: Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage1- Collection of Video-clinical Data in a Pragmatic Situation.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Cerebrovascular
Keywords: Artificial Intelligence
Data bank
Video recording
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: Société par Action Simplifiée AI-Stroke
First posted: 2023-07-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study authors aim to form a collection of video-clinical data in a pragmatic situation to enable the development of relevant AI algorithms (for both hetero- and self-diagnosis modes). The aim is to optimize management through early diagnosis (self- and hetero-diagnosis) and thus to reduce sequelae disability.

The study authors hypothesize that some stroke patients will be able to successfully perform a self-test consisting of a few exercises dictated by an application on a smartphone or tablet and recorded on video.


Eligibility criteria: Inclusion Criteria:

* Patients treated in the emergency department or hospitalized in the NICU at the CHU de Nîmes for suspected stroke or transient ischemic attack in the acute phase (\<72h), with or without motor deficit
* Patient to be seen again in consultation within 4 months
* Patient has given free and informed consent and signed the consent form. If the patient is not in a position to give consent, it must be obtained, prior to filming the first video, from the designated trusted support person or relatives present. In this case, data will not be used until the patient is able to sign the consent (CNIL).
* Patient affiliated or beneficiary of a health insurance scheme

Exclusion Criteria:

* Patients who do not speak or read French.
* Patient in a period of exclusion determined by another study.
* Patient under court protection, guardianship or curatorship.
* Pregnant, parturient or breast-feeding patients.

Primary outcomes:
measure: Usable video recording made by the patient
timeFrame: Day 0
measure: Usable video recording made by the hospital worker
timeFrame: Day 0
Secondary outcomes:
measure: Usable video recording made by the patient
timeFrame: Month 3
measure: Usable video recording made by the hospital worker
timeFrame: Month 3
measure: Feasibility of patient self-recording
timeFrame: Day 0
measure: Feasibility of patient self-recording
timeFrame: Month 3
measure: Acceptability of self-recording by patients
timeFrame: Month 3
measure: Patient-reported ease of self-recording
timeFrame: Day 0
measure: Patient-reported ease of self-recording
timeFrame: Month 3
measure: Stroke severity
timeFrame: Day 0
measure: Stroke severity
timeFrame: Month 3
measure: Degree of disability following stroke
timeFrame: Day 0
measure: Degree of disability following stroke
timeFrame: Month 3
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire
state: Gard
Study officials:
affiliation: CHU de Nimes
name: Anne WACONGNE
role: PRINCIPAL_INVESTIGATOR
References: