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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 : February 26, 2024
Sponsor:
Collaborator:
Société par Action Simplifiée AI-Stroke
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date  ICMJE July 17, 2023
First Posted Date  ICMJE July 25, 2023
Last Update Posted Date February 26, 2024
Actual Study Start Date  ICMJE August 28, 2023
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2023)
  • Usable video recording made by the patient [ Time Frame: Day 0 ]
    Recording using AI-STROKE application
  • Usable video recording made by the hospital worker [ Time Frame: Day 0 ]
    Recording using AI-STROKE application
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2023)
  • Usable video recording made by the patient [ Time Frame: Month 3 ]
    Recording using AI-STROKE application
  • Usable video recording made by the hospital worker [ Time Frame: Month 3 ]
    Recording using AI-STROKE application
  • Feasibility of patient self-recording [ Time Frame: Day 0 ]
    Patient able to record without assistance: yes/no
  • Feasibility of patient self-recording [ Time Frame: Month 3 ]
    Patient able to record without assistance: yes/no
  • Acceptability of self-recording by patients [ Time Frame: Month 3 ]
    Patient accepting to self-record: Yes/no
  • Patient-reported ease of self-recording [ Time Frame: Day 0 ]
    Visual numerical scale 0-10
  • Patient-reported ease of self-recording [ Time Frame: Month 3 ]
    Visual numerical scale 0-10
  • Stroke severity [ Time Frame: Day 0 ]
    NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
  • Stroke severity [ Time Frame: Month 3 ]
    NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Stroke, Cerebrovascular
Intervention  ICMJE Other: AI-STROKE application
Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application
Study Arms  ICMJE Experimental: Patients with suspected acute stroke
Intervention: Other: AI-STROKE application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 17, 2023)		 300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Eric Thouvenot 04.66.68.32.51 eric.thouvenot@chu-nimes.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05959746
Other Study ID Numbers  ICMJE CIVI/2022/ET-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Centre Hospitalier Universitaire de Nīmes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Centre Hospitalier Universitaire de Nīmes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Société par Action Simplifiée AI-Stroke
Investigators  ICMJE
Principal Investigator: Eric Thouvenot CHU de Nimes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP