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.

Not Applicable

Recruiting

• Conditions: Stroke, Cerebrovascular

• Registration Number: NCT05959746
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Study First Posted: 2023-07-25
• Study Start: 2023-08-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usable video recording made by the patient	Day 0	Recording using AI-STROKE application
Usable video recording made by the hospital worker	Day 0	Recording using AI-STROKE application

Secondary Outcome Measures

Name	Time	Method
Acceptability of self-recording by patients	Month 3	Patient accepting to self-record: Yes/no
Patient-reported ease of self-recording	Month 3	Visual numerical scale 0-10
Feasibility of patient self-recording	Month 3	Patient able to record without assistance: yes/no
Degree of disability following stroke	Month 3	mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Usable video recording made by the patient	Month 3	Recording using AI-STROKE application
Usable video recording made by the hospital worker	Month 3	Recording using AI-STROKE application
Stroke severity	Month 3	NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Nîmes, Gard, France