Using a digital twin app to support people in secondary prevention after stroke, Moyamoya disease, or cerebral amyloid angiopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized 1:1 proof-of-concept trial enrolling adults with stroke, Moyamoya disease, or cerebral amyloid angiopathy admitted to the Cerebrovascular Disease Unit at the Carlo Besta Institute. Participants randomized to the intervention will receive standard secondary prevention plus the STRATIF-AI app, which uses a digital twin to explain risk factors, support goal-setting, and optionally connect to wearable devices; the control arm will receive standard secondary prevention alone. Clinical, cognitive, and psychological evaluations are performed at enrollment and at a six-month follow-up, and intervention-arm participants will take part in usability interviews at six months; initial app instruction adds about 30 minutes to the first visit. The primary focus is collecting patient experience and usability feedback on implementing digital twin technology in secondary prevention rather than demonstrating clinical endpoint changes in this proof-of-concept phase.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondazione IRCCS Istituto Neurologico Carlo Besta
  Milan, Michigan, Italy Recruiting

Study contacts

• Study coordinator: Matilde Leonardi, MD
• Email: matilde.leonardi@istituto-besta.it
• Phone: +39 02 2394 2511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.