Using a digital twin app to support people in secondary prevention after stroke, Moyamoya disease, or cerebral amyloid angiopathy
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)
NA · Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06714097
This trial will try the STRATIF-AI app plus usual secondary prevention care to see if it improves daily self-care and the patient experience for adults after stroke, Moyamoya disease, or CAA.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta (other) |
| Locations | 1 site (Milan, Michigan) |
| Trial ID | NCT06714097 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with a clinical and neuroradiological diagnosis of stroke, Moyamoya disease, or CAA who have MoCA ≥23, mRS ≤2, can undergo MRI, are first-time patients at the center, and can give informed consent are ideal candidates.
Not a fit: Patients with significant cognitive impairment, higher disability (mRS >2), inability to use a smartphone or app, contraindications to MRI, or those unlikely to complete follow-up are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could help patients better understand their risk factors, improve self-management and adherence to secondary prevention, and reduce the chance of recurrent events through more informed daily care.
How similar studies have performed: Related digital health and wearable interventions have shown modest improvements in self-care and adherence, but applying digital twin technology specifically to stroke secondary prevention is largely novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Milan, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Moyamoya Disease, Cerebral Amyloid Angiopathy, stroke, secondary prevention, digital twin