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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.

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.

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05959746
Acronym
PREDISTROKE
Enrollment
300
Registered
2023-07-25
Start date
2023-08-28
Completion date
2024-12-31
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Cerebrovascular

Keywords

Artificial Intelligence, Data bank, Video recording

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.

Interventions

OTHERAI-STROKE application

Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application

Sponsors

Société par Action Simplifiée AI-Stroke
CollaboratorUNKNOWN
Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Usable video recording made by the patientDay 0Recording using AI-STROKE application
Usable video recording made by the hospital workerDay 0Recording using AI-STROKE application

Secondary

MeasureTime frameDescription
Feasibility of patient self-recordingDay 0Patient able to record without assistance: yes/no
Acceptability of self-recording by patientsMonth 3Patient accepting to self-record: Yes/no
Usable video recording made by the patientMonth 3Recording using AI-STROKE application
Stroke severityDay 0NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Degree of disability following strokeDay 0mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Patient-reported ease of self-recordingDay 0Visual numerical scale 0-10
Usable video recording made by the hospital workerMonth 3Recording using AI-STROKE application

Countries

France

Contacts

Primary ContactAnne WACONGNE
anne.wacongne@chu-nimes.fr04.66.68.32.51

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026