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NCT Number: 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.

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Nîmes, Gard, 30029, France

Location status: Recruiting

Location contact

Anissa MEGZARI

CONTACT

[email protected]

04 66 68 30 52

Anne Wacongne, M.

CONTACT

Dimitri Renard

CONTACT

Eric THOUVENOT, Pr.

CONTACT

Marc Hackius

CONTACT

Teodora PARVU

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI-STROKE application

Other

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

Primary outcomes

  1. Usable video recording made by the patient

    Time frame: Day 0

    Recording using AI-STROKE application

  2. Usable video recording made by the hospital worker

    Time frame: Day 0

    Recording using AI-STROKE application

Secondary outcomes

  1. Usable video recording made by the patient

    Time frame: Month 3

    Recording using AI-STROKE application

  2. Usable video recording made by the hospital worker

    Time frame: Month 3

    Recording using AI-STROKE application

  3. Feasibility of patient self-recording

    Time frame: Day 0

    Patient able to record without assistance: yes/no

  4. Feasibility of patient self-recording

    Time frame: Month 3

    Patient able to record without assistance: yes/no

  5. Acceptability of self-recording by patients

    Time frame: Month 3

    Patient accepting to self-record: Yes/no

  6. Patient-reported ease of self-recording

    Time frame: Day 0

    Visual numerical scale 0-10

  7. Patient-reported ease of self-recording

    Time frame: Month 3

    Visual numerical scale 0-10

  8. Stroke severity

    Time frame: Day 0

    NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist

  9. Stroke severity

    Time frame: Month 3

    NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist

  10. Degree of disability following stroke

    Time frame: Day 0

    mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist

  11. Degree of disability following stroke

    Time frame: Month 3

    mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist

Study contacts

Contact information is provided by the study sponsor or research team.

Anne WACONGNE

CONTACT

[email protected]

04.66.68.32.51

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Société par Action Simplifiée AI-Stroke

Registry information

Acronym: PREDISTROKE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2023
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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