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StrokeEarly Phase 1AIDENNCT06334796

Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology

A Early Phase 1 study testing Virtual Assistant in people with Stroke and Guillain-Barre Syndrome, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Guillain-Barre Syndrome, Facial Palsy
What is being tested?
Virtual Assistant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteArgentina
Study dates
1 Oct 2023to 1 Jan 2024
Phase
Early Phase 1
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 over 18 years old consulting in the ER due to a neurological emergency

Who cannot join

  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Fleni

    Buenos Aires, 1428

Other trials in Argentina

About this study

Official title: Phase 1 Trial of the Implementation of an Artificial Intelligence-powered Virtual Assistant for Emergency Triage in Neurology

This study examines the use of an AI-powered virtual assistant for quickly identifying and handling neurological emergencies, particularly in places with limited medical resources. The research aimed to check if this AI tool is safe and accurate enough to move on to more advanced testing stages. In a first-of-its-kind trial, the virtual assistant was tested with patients having urgent neurological issues. Neurologists first reviewed the AI's recommendations using clinical records and then assessed its performance directly with patients. The findings were as follows: neurologists agreed with the AI's decisions nearly all the time, and the AI outperformed earlier versions of Chat GPT in every tested aspect. Patients and doctors found the AI to be highly effective, rating it as excellent or very good in most cases. This suggests the AI could significantly enhance how quickly and accurately neurological emergencies are dealt with, although further trials are needed before it can be widely used.

Read the detailed description

Background and Objectives: Neurological emergencies pose significant challenges in medical care, especially in resource-limited countries. Artificial Intelligence (AI), particularly health chatbots, offers a promising solution. However, rigorous validation is required to ensure safety and accuracy. The objective of our work is to evaluate the diagnostic accuracy and resolution effectiveness of an AI-powered virtual assistant designed for the triage of emergency neurological pathologies, to ensure the minimum standard of safety that allows for the progression to successive validation tests.

Methods: This Phase 1 trial evaluates the performance of an AI-powered virtual assistant for emergency neurological triage. Ten patients over 18 years old with urgent neurological pathologies were selected. In the first stage, nine neurologists assessed the safety of the virtual assistant using their clinical records. In the second part, the assistant's accuracy when used by patients was evaluated. Finally, its performance was compared with Chat GPT 3.5 and 4.

Being tested
Virtual Assistant
Medical subject headings
Stroke, Guillain-Barre Syndrome, Facial Paralysis, Migraine Disorders, Status Epilepticus, Benign Paroxysmal Positional Vertigo, Delirium, Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual AssistantDiagnostic test

    Stage 1 focused on safety, using only medical information from clinical records for the virtual assistant. In Stage 2, which evaluated accuracy, participants interacted with the virtual assistant post-medical stabilization. Additionally, participants also provided initial symptom details for Chat-GPT input. Nine neurologists specializing in emergency participated in the study. In Stage 1, they assessed the virtual assistant's performance using clinical history information. In Stage 2, they analyzed the results from participant interactions with the assistant and performed a comparative evaluation of Chat-GPT. The virtual assistant functioned as a chatbot on WhatsApp and Telegram, using Spanish and incorporating advanced algorithms, decision trees, and large language models for interaction. For comparison, we utilized Chat-GPT versions 3.5 and 4, employing two prompt types in natural Spanish: one incorporating clinical record data and the other based on participant narratives.

Study groups in NCT06334796
Study groupRoleWhat they receive
Virtual AssistantExperimentalPatients answer question with a virtual assistant about their recent visit to the ER.
Receives: Diagnostic Test: Virtual Assistant
ChatGPT 3.5Active comparatorPatients answer question with ChatGPT about their recent visit to the ER.
Receives: Diagnostic Test: Virtual Assistant
ChatGPT 4Active comparatorPatients answer question with ChatGPT about their recent visit to the ER.
Receives: Diagnostic Test: Virtual Assistant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic performance

    Refers to the accuracy and effectiveness of medical tests or diagnostic tools in correctly identifying a disease or condition in patients.

    Syndromic diagnosis agreement: evaluating neurologists considered a syndromic diagnosis accurate when AI tools could identify a condition based on a set of commonly coexisting signs and symptoms, rather than identifying a specific disease. This method is applied when the precise disease causing the symptoms is not immediately identifiable, allowing healthcare providers to effectively monitor and treat the patient's presenting symptoms.

    Differential diagnosis agreement: a differential diagnosis was considered accurate when the differentials provided by each AI tool matched those presented by the participants.

    The gold standard for diagnosis was considered to be the one given in the emergency department, unchanged over a one-month period.

    Measured: The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.

Secondary outcomes (2)

  1. Appropriate medical conduct or recommendation

    Case resolution was evaluated based on appropriate medical conduct or recommendation, categorizing 1) urgency as immediate, 2) short-term (within 48 hours), 3) or non-urgent.

    The recommendations provided by each AI tool were assessed based on information gathered from clinical histories and input from participants.

    The gold standard of appropriate medical conduct or recommendation was considered to be that given in the emergency department, with no changes over a period of one month.

    Measured: The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.

  2. Assessment of Usability and Satisfaction

    Usability was measured by the time and number of questions needed for final diagnosis and resolution, both by neurologists and participants. For Chat GPT, we evaluated the time taken to draft the consultation reason.

    A satisfaction scale from 1 to 5 was implemented, with 1 indicating a negative experience ("poor", potentially risky for the patient) and 5 highly positive ("excellent", potentially surpassing non-specialized human triage). A simple yes/no survey was also applied to participants, asking about the comprehensibility of the assistant's questions, the adequacy of referral according to urgency, and whether they considered the assistant could replace non-specialized triage or reduce emergency arrival time.

    Measured: The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start1 Oct 2023
  3. Primary completion1 Jan 2024
  4. Study completion1 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Model description
The model of this Phase 1 interventional study involves evaluating the diagnostic accuracy and utility of an AI-powered virtual assistant in the triage of emergency neurological conditions. Patients and healthcare professionals interacted with the assistant, providing real-world clinical scenarios to assess its effectiveness. The study's design aimed to demonstrate the assistant's potential to enhance emergency neurological care by comparing its performance with established diagnostic tools and patient outcomes.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334796
Sponsor's protocol ID
10476
Acronym
AIDEN
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will not share IPD

Publications

  • Haug CJ, Drazen JM. Artificial Intelligence and Machine Learning in Clinical Medicine, 2023. N Engl J Med. 2023 Mar 30;388(13):1201-1208. doi: 10.1056/NEJMra2302038. No abstract available.

    PubMed 36988595

  • Au Yeung J, Wang YY, Kraljevic Z, Teo JTH. Artificial intelligence (AI) for neurologists: do digital neurones dream of electric sheep? Pract Neurol. 2023 Nov 23;23(6):476-488. doi: 10.1136/pn-2023-003757.

    PubMed 37977806

  • Patel UK, Anwar A, Saleem S, Malik P, Rasul B, Patel K, Yao R, Seshadri A, Yousufuddin M, Arumaithurai K. Artificial intelligence as an emerging technology in the current care of neurological disorders. J Neurol. 2021 May;268(5):1623-1642. doi: 10.1007/s00415-019-09518-3. Epub 2019 Aug 26.

    PubMed 31451912

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Virtual Assistant in people with Stroke and Guillain-Barre Syndrome, run by Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia at 1 site in Argentina.

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 1 inclusion and 1 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 28 Mar 2024. 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 Argentina. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Diagnostic performance (time frame: The first interaction between participants and the virtual assistant occurred within less than a year after the event. Outcome measures were evaluated immediately after the interaction between patients and the virtual assistant.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06334796, which also lists 3 linked publications.

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 28 Mar 2024.

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AIDEN Clinical Trial NCT06334796 | AzTrials