Tests a digital twin health app in stroke, Moyamoya disease and cerebral amyloid angiopathy
Tests an AI health app in adults after stroke or brain vessel disease.
Plain-language title generated from the registry record
Registry title: Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- Fondazione IRCCS Istituto Neurologico Carlo BestaMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Trial code
- NCT06714097
- Record updated
- 10 November 2026
- Original description
The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.Read full original descriptionShow less
Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)
The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.
The main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform? Researchers will compare Arm 1, who use the STRATIF-AI app in addition to standard secondary prevention, against Arm 2, who receive standard secondary prevention only, to collect feedback regarding the platform usability.
Participants in the Arm 1 will:
* Complete cognitive and psychological assessments at the time of the first visit and after six months * Follow the indications received from the clinician for standard secondary prevention * Use the STRATIF-AI app daily for health management * Optionally, purchase wearable devices that connect to the app. * Participate in interviews at the six-month mark to share their experiences with the app.
Patients in the Arm 2 will:
* Complete cognitive and psychological assessments at the time of the first visit and after six months * Follow the indications received from the clinician for standard secondary prevention
Inclusion: People aged ≥ 18; Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021; MOCA total score ≥ 23; modified Rankin Scale (mRS) ≤ 2; First-time patients at the Besta Institute; Ability to sign informed consent; Possibility of performing a brain MRI.
Exclusion: Known or suspected drug or alcohol abuse; Patients with transient neurological deficits that resolve within an hour and normal brain imaging; Patient under legal protection or deprived of liberty by judicial or administrative decision; Patient whose follow-up will be impossible; Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA); Pregnant patients.