Back to resultsClinical 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)
Primary Purpose
Stroke, Cerebrovascular
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
AI-STROKE application
Sponsored by
About this trial
This is an interventional diagnostic trial for Stroke, Cerebrovascular focused on measuring Artificial Intelligence, Data bank, Video recording
Eligibility 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.
Sites / Locations
- Centre Hospitalier UniversitaireRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with suspected acute stroke
Arm Description
Outcomes
Primary Outcome Measures
Usable video recording made by the patient
Recording using AI-STROKE application
Usable video recording made by the hospital worker
Recording using AI-STROKE application
Secondary Outcome Measures
Usable video recording made by the patient
Recording using AI-STROKE application
Usable video recording made by the hospital worker
Recording using AI-STROKE application
Feasibility of patient self-recording
Patient able to record without assistance: yes/no
Feasibility of patient self-recording
Patient able to record without assistance: yes/no
Acceptability of self-recording by patients
Patient accepting to self-record: Yes/no
Patient-reported ease of self-recording
Visual numerical scale 0-10
Patient-reported ease of self-recording
Visual numerical scale 0-10
Stroke severity
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Stroke severity
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Degree of disability following stroke
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Degree of disability following stroke
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Full Information
NCT ID
NCT05959746
First Posted
July 17, 2023
Last Updated
October 6, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Société par Action Simplifiée AI-Stroke
1. Study Identification
Unique Protocol Identification Number
NCT05959746
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.
Acronym
PREDISTROKE
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 28, 2023 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Société par Action Simplifiée AI-Stroke
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular
Keywords
Artificial Intelligence, Data bank, Video recording
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with suspected acute stroke
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
AI-STROKE application
Intervention Description
Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application
Primary Outcome Measure Information:
Title
Usable video recording made by the patient
Description
Recording using AI-STROKE application
Time Frame
Day 0
Title
Usable video recording made by the hospital worker
Description
Recording using AI-STROKE application
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Usable video recording made by the patient
Description
Recording using AI-STROKE application
Time Frame
Month 3
Title
Usable video recording made by the hospital worker
Description
Recording using AI-STROKE application
Time Frame
Month 3
Title
Feasibility of patient self-recording
Description
Patient able to record without assistance: yes/no
Time Frame
Day 0
Title
Feasibility of patient self-recording
Description
Patient able to record without assistance: yes/no
Time Frame
Month 3
Title
Acceptability of self-recording by patients
Description
Patient accepting to self-record: Yes/no
Time Frame
Month 3
Title
Patient-reported ease of self-recording
Description
Visual numerical scale 0-10
Time Frame
Day 0
Title
Patient-reported ease of self-recording
Description
Visual numerical scale 0-10
Time Frame
Month 3
Title
Stroke severity
Description
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Time Frame
Day 0
Title
Stroke severity
Description
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Time Frame
Month 3
Title
Degree of disability following stroke
Description
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Time Frame
Day 0
Title
Degree of disability following stroke
Description
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Time Frame
Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Thouvenot
Phone
04.66.68.32.51
Email
eric.thouvenot@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Thouvenot
Organizational Affiliation
CHU de Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa MEGZARI
Phone
04 66 68 30 52
Email
anissa.megzari@CHU-nimes.fr
First Name & Middle Initial & Last Name & Degree
Eric THOUVENOT, Pr.
First Name & Middle Initial & Last Name & Degree
Anne Wacongne, M.
First Name & Middle Initial & Last Name & Degree
Dimitri Renard
First Name & Middle Initial & Last Name & Degree
Teodora PARVU
First Name & Middle Initial & Last Name & Degree
Marc Hackius
12. IPD Sharing Statement
Learn more about this trial
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.
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