Stroke Clinical Trial
— AIDENOfficial 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.
Status | Completed |
Enrollment | 10 |
Est. completion date | January 1, 2024 |
Est. primary completion date | January 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients over 18 years old consulting in the ER due to a neurological emergency Exclusion Criteria: - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Argentina | Fleni | Buenos Aires |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia | Entelai |
Argentina,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
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 | 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. |
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 | 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. |
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. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04043052 -
Mobile Technologies and Post-stroke Depression
|
N/A | |
Recruiting |
NCT03869138 -
Alternative Therapies for Improving Physical Function in Individuals With Stroke
|
N/A | |
Completed |
NCT04034069 -
Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial
|
N/A | |
Completed |
NCT04101695 -
Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects
|
N/A | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Completed |
NCT00391378 -
Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS)
|
N/A | |
Recruiting |
NCT06204744 -
Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial
|
N/A | |
Active, not recruiting |
NCT06043167 -
Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
|
||
Active, not recruiting |
NCT04535479 -
Dry Needling for Spasticity in Stroke
|
N/A | |
Completed |
NCT03985761 -
Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke
|
N/A | |
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Recruiting |
NCT06034119 -
Effects of Voluntary Adjustments During Walking in Participants Post-stroke
|
N/A | |
Completed |
NCT03622411 -
Tablet-based Aphasia Therapy in the Chronic Phase
|
N/A | |
Completed |
NCT01662960 -
Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke
|
N/A | |
Recruiting |
NCT05854485 -
Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke
|
N/A | |
Active, not recruiting |
NCT05520528 -
Impact of Group Participation on Adults With Aphasia
|
N/A | |
Completed |
NCT03366129 -
Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT05805748 -
Serious Game Therapy in Neglect Patients
|
N/A | |
Recruiting |
NCT05993221 -
Deconstructing Post Stroke Hemiparesis
|