Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05959746

Clinical Development of a Tool for Optimized Self- and Hetero-diagnosis of Stroke Using Artificial Intelligence: Stage 1 - Collection of Video-Clinical Data in a Pragmatic Situation

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2024-11-27

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

C

Centre Hospitalier Universitaire de Nīmes

Lead Sponsor

S

Société par Action Simplifiée AI-Stroke

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing an artificial intelligence tool to improve early detection of stroke by enabling both self-diagnosis and diagnosis by others using video recordings. The study aims to collect video and clinical data in real-life settings to support the creation of AI algorithms that can help reduce disability after stroke by facilitating timely diagnosis. This research focuses on patients suspected of acute stroke or transient ischemic attack within 72 hours of symptom onset. Participants will use the AI-STROKE application to perform a complete neurological exam, which will be recorded on video by both healthcare workers and the patients themselves. The study involves initial video recordings on Day 0 and follow-up recordings at 3 months. The goal is to assess the feasibility and acceptability of patient self-recording, as well as the quality of videos taken by patients and hospital staff. During the study, participants will be assessed at the hospital and again within 4 months to evaluate stroke severity and disability. Researchers will collect data on the ease and acceptability of self-recording, along with video quality. Outcome measures include usable video recordings from patients and hospital workers on Day 0 and Month 3, patient-reported experiences, and clinical assessments of stroke severity and disability over time. The study is sponsored by Centre Hospitalier Universitaire de Nîmes and does not involve masking or placebo control.

CONDITIONS

Brief 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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 (<72 hours), 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, or consent obtained from a designated trusted support person if patient unable to consent
  • Patient affiliated or beneficiary of a health insurance scheme
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to 3 days

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Day 0

Participants undergo video-recorded neurological exams using the AI-STROKE application performed by healthcare workers and themselves to assess stroke symptoms.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 3 months

Participants are followed up with repeat video recordings and assessments to evaluate stroke severity, disability, and feasibility of self-recording.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

Centre Hospitalier Universitaire

Nîmes, Gard, France, 30029

Actively Recruiting

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Research Team

A

Anne WACONGNE

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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