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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-STROKE application.
- Who it may be relevant to
- Registry conditions: Stroke, Cerebrovascular. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other AI-STROKE application
Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application
Primary outcome measures
- Usable video recording made by the patient [Time frame: Day 0]
- Usable video recording made by the hospital worker [Time frame: Day 0]
Secondary outcome measures (11)
- Usable video recording made by the patient [Time frame: Month 3]
- Usable video recording made by the hospital worker [Time frame: Month 3]
- Feasibility of patient self-recording [Time frame: Day 0]
- Feasibility of patient self-recording [Time frame: Month 3]
- Acceptability of self-recording by patients [Time frame: Month 3]
- Patient-reported ease of self-recording [Time frame: Day 0]
- Patient-reported ease of self-recording [Time frame: Month 3]
- Stroke severity [Time frame: Day 0]
- Stroke severity [Time frame: Month 3]
- Degree of disability following stroke [Time frame: Day 0]
- Degree of disability following stroke [Time frame: Month 3]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Hospitalier Universitaire — Nîmes
Identifiers
NCT: NCT05959746 · CIVI/2022/ET-01