Actively Recruiting
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)
Led by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · Updated on 2026-03-30
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- People aged �3E�2D= 18 years
- Clinical and neuroradiological diagnosis of stroke (TAC or MR), diagnosis of CAA based on Boston 2.0 criteria, or diagnosis of Moyamoya disease based on 2021 criteria
- Montreal Cognitive Assessment (MOCA) total score �3E�2D= 23
- Modified Rankin Scale (mRS) score �3C�3D 2
- First-time patients at the Besta Institute
- Ability to sign informed consent
- Ability to undergo a brain MRI
You will not qualify if you...
- Transient neurological deficits that resolve within an hour with normal brain imaging
- Under legal protection or deprived of liberty by judicial or administrative decision
- Inability to complete follow-up
- Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA)
- Pregnant patients
- Known or suspected drug or alcohol abuse
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan, Michigan, Italy, 20133
Actively Recruiting
Research Team
M
Matilde Leonardi, MD
CONTACT
B
Barbara Maistrello
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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