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)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI

    Device

    STRATIF-AI apps will be used as an integral part of the dialogue with patients during thesecondary prevention phase

  • healthy dialogue

    Other intervention

    Patients allocated to arm 2 will receive only standard secondary prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Standard secondary prevention + digital twinExperimental treatment 1 intervention
Group B: Standard secondary prevention onlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Feedback from users

To get initial feedback on the patients' experience regarding the use of the STRATIF-AIplatform in the secondary prevention phase.

Time frame
12 months

Secondary outcomes

1

feedback to developers

feedback to development team. This will be used as a starting point for future studiesand for conversations with other clinics, politicians, and policy maker.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.