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)
| NCT ID | NCT06714097 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2026-04 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06714097 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06714097 currently recruiting?
Yes, NCT06714097 is actively recruiting participants. Contact the research team at matilde.leonardi@istituto-besta.it for enrollment information.
Where is the NCT06714097 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06714097 clinical trial?
NCT06714097 is sponsored by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta. The trial plans to enroll 20 participants.
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