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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. (PREDISTROKE)

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ClinicalTrials.gov Identifier: NCT05959746
Recruitment Status : Recruiting
First Posted : July 25, 2023
Last Update Posted : October 10, 2023
Sponsor:
Collaborator:
Société par Action Simplifiée AI-Stroke
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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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.


Condition or disease Intervention/treatment Phase
Stroke, Cerebrovascular Other: AI-STROKE application Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official 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.
Actual Study Start Date : August 28, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with suspected acute stroke Other: AI-STROKE application
Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05959746


Contacts
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Contact: Eric Thouvenot 04.66.68.32.51 eric.thouvenot@chu-nimes.fr

Locations
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France
Centre Hospitalier Universitaire Recruiting
Nîmes, Gard, France, 30029
Contact: Anissa MEGZARI    04 66 68 30 52    anissa.megzari@CHU-nimes.fr   
Principal Investigator: Eric THOUVENOT, Pr.         
Sub-Investigator: Anne Wacongne, M.         
Sub-Investigator: Dimitri Renard         
Sub-Investigator: Teodora PARVU         
Sub-Investigator: Marc Hackius         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Société par Action Simplifiée AI-Stroke
Investigators
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Principal Investigator: Eric Thouvenot CHU de Nimes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT05959746    
Other Study ID Numbers: CIVI/2022/ET-01
First Posted: July 25, 2023    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Artificial Intelligence
Data bank
Video recording
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases