Stroke, CerebrovascularPREDISTROKENCT05959746
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.
A study testing AI-STROKE application in people with Stroke, Cerebrovascular, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular
- What is being tested?
- AI-STROKE application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 28 Aug 2023to 27 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- AI-STROKE application
- Keywords
- Artificial Intelligence, Data bank, Video recording
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-STROKE applicationOther
Complete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected acute stroke | Experimental | Not described Receives: Other: AI-STROKE application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usable video recording made by the patient
Recording using AI-STROKE application
Measured: Day 0
Usable video recording made by the hospital worker
Recording using AI-STROKE application
Measured: Day 0
Secondary outcomes (11)
Usable video recording made by the patient
Recording using AI-STROKE application
Measured: Month 3
Usable video recording made by the hospital worker
Recording using AI-STROKE application
Measured: Month 3
Feasibility of patient self-recording
Patient able to record without assistance: yes/no
Measured: Day 0
Feasibility of patient self-recording
Patient able to record without assistance: yes/no
Measured: Month 3
Acceptability of self-recording by patients
Patient accepting to self-record: Yes/no
Measured: Month 3
Patient-reported ease of self-recording
Visual numerical scale 0-10
Measured: Day 0
Patient-reported ease of self-recording
Visual numerical scale 0-10
Measured: Month 3
Stroke severity
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Measured: Day 0
Stroke severity
NIHSS (National Institute of Health Stroke Scale) score assessed by neurologist
Measured: Month 3
Degree of disability following stroke
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Measured: Day 0
Degree of disability following stroke
mRS (modified Rankin Scale) score, range 0 (no symptoms) to 5 (severe handicap) administered by the neurologist
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start28 Aug 2023
- Primary completion27 Jan 2025
- Study completion27 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, CerebrovascularStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Société par Action Simplifiée AI-Stroke
- Responsible party
- Sponsor
- Investigators
- Anne WACONGNE, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959746
- Sponsor's protocol ID
- CIVI/2022/ET-01
- Acronym
- PREDISTROKE
- Status last verified
- Oct 2026
- First submitted
- 17 Jul 2023
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05959746
- Acronym / sponsor ID
- PREDISTROKE / CIVI/2022/ET-01
- Conditions
- Stroke, Cerebrovascular
- Keywords
- Artificial Intelligence, Data bank, Video recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Société par Action Simplifiée AI-Stroke
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 27 Jan 2025 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected acute stroke | Experimental | Other: AI-STROKE application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-STROKE applicationComplete neurological exam of stroke patients will be filmed by healthcare workers and themselves using the AI-STROKE application | Other | Patients with suspected acute stroke |
Primary outcome
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
11 secondary outcomes
Usable video recording made by the patient
Time frame: Month 3
Usable video recording made by the hospital worker
Time frame: Month 3
Feasibility of patient self-recording
Time frame: Day 0
Feasibility of patient self-recording
Time frame: Month 3
Acceptability of self-recording by patients
Time frame: Month 3
Patient-reported ease of self-recording
Time frame: Day 0
Patient-reported ease of self-recording
Time frame: Month 3
Stroke severity
Time frame: Day 0
Stroke severity
Time frame: Month 3
Degree of disability following stroke
Time frame: Day 0
Degree of disability following stroke
Time frame: Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne WACONGNE principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-STROKE application in people with Stroke, Cerebrovascular, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usable video recording made by the patient (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.