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)

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Cerebrovascular
• Intervention / Treatment: Other: AI-STROKE application

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne WACONGNE; Phone Number: 04.66.68.32.51; Email: anne.wacongne@chu-nimes.fr

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30029
      • Recruiting
      • Centre Hospitalier Universitaire
      • Contact: Dimitri Renard
      • Contact: Anissa MEGZARI; Phone Number: 04 66 68 30 52; Email: anissa.megzari@CHU-nimes.fr
      • Contact: Eric THOUVENOT, Pr.
      • Contact: Anne Wacongne, M.
      • Contact: Teodora PARVU
      • Contact: Marc Hackius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usable video recording made by the patient	Recording using AI-STROKE application	Day 0
Usable video recording made by the hospital worker	Recording using AI-STROKE application	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usable video recording made by the patient	Recording using AI-STROKE application	Month 3
Usable video recording made by the hospital worker	Recording using AI-STROKE application	Month 3
Feasibility of patient self-recording	Patient able to record without assistance: yes/no	Day 0
Feasibility of patient self-recording	Patient able to record without assistance: yes/no	Month 3
Acceptability of self-recording by patients	Patient accepting to self-record: Yes/no	Month 3
Patient-reported ease of self-recording	Visual numerical scale 0-10	Day 0
Patient-reported ease of self-recording	Visual numerical scale 0-10	Month 3
Stroke severity	NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist	Day 0
Stroke severity	NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist	Month 3
Degree of disability following stroke	mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist	Day 0
Degree of disability following stroke	mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist	Month 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: Société par Action Simplifiée AI-Stroke
• Investigators: Principal Investigator: Anne WACONGNE, CHU de Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 17, 2023
• First Submitted That Met QC Criteria: July 17, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Estimated): November 27, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Artificial Intelligence; Video recording; Data bank
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: CIVI/2022/ET-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No