Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and … (NCT06714097) | Clinical Trial Compass
RecruitingNot Applicable
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)
Italy20 participantsStarted 2026-04
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Known or suspected drug or alcohol abuse
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feedback from users
Timeframe: 12 months
Trial details
NCT IDNCT06714097
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta