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.

NCT05959746 | Recruiting

• 1 other identifier: CIVI/2022/ET-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Cerebrovascular

Keywords

Artificial Intelligence; Data bank; Video recording

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Usable video recording made by the patient

  Month 3

• Usable video recording made by the hospital worker

  Month 3

• Feasibility of patient self-recording

  Day 0

• Feasibility of patient self-recording

  Month 3

• Acceptability of self-recording by patients

  Month 3

Study Arms (1)

Patients with suspected acute stroke

EXPERIMENTAL

Other: AI-STROKE application

Interventions

AI-STROKE application OTHER

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

Patients with suspected acute stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who do not speak or read French.
• Patient under court protection, guardianship or curatorship.
• Pregnant, parturient or breast-feeding patients.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• Société par Action Simplifiée AI-Stroke: collaborator

Study Sites (1)

Centre Hospitalier Universitaire

Nîmes, Gard, 30029, France

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anne WACONGNE

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne WACONGNE

CONTACT

04.66.68.32.51; anne.wacongne@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: August 28, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)