Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06714097

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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