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) (SMART)

March 25, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

AIMS

Patients in secondary prevention with Moyamoya, CAA and stroke admitted to the Cerebrovascular Disease Unit of Carlo Besta Neurological Institute will be enrolled and randomized 1:1 in the following two arms:

  • Arm 1 is the intervention group: patients allocated to this arm will receive the standard secondary prevention and will also use the STRATIF-AI app, which will integrate digital twin (DT) technology to improve patient management during the secondary prevention phase and to assist patients in understanding key concepts, such as: "Why should I care about a certain risk factor (e.g. blood pressure), and how can my lifestyle impact that risk factor? In other words, they will use the app to understand their medical situation, and to set personal goals.
  • Arm 2 is the control group: patients allocated to this arm will receive only standard seconda prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA.

Patients will be screened and enrolled upon admission to the Cerebrovascular Disease Unit. They will complete a set of clinical, cognitive, and psychological evaluation, performed at the time point of enrolment (T0) and at a 6-months follow-up (T1).

Only for the Arm 1, a brief explanation about the use of the app will add about 30 minutes to the initial visit. Afterward, patients can use the app at their discretion to assist in self-care. The app also offers the option to connect to wearable devices.

This study involves the collection of quantitative and qualitative data as follows:

  1. Quantitative data:

    • Cognitive status will be evaluated with Montreal Cognitive Assessment (MOCA) test
    • General health and disability status will be evaluated with Patient Reported Outcome Measures: Short Form Health Survey 36 (SF-36), WHO Disability Assessment Schedule (WHO DAS 2.0),
    • Psychological status will be evaluated with Center for Epidemiologic Studies Depression Scales (CES-D), General Anxiety Disorder 7-Item (GAD-7), Fatigue Severity Scale, Impact of Event Scale Revised (IES-R).
    • Clinical functioning will be evaluated using the modified Rankin scale (mRS) and the Clinical Functioning Information Tool (ClinFIT).

    Moreover, we will collect clinical variables such as: TFNE (Transient Focal Neurological Episodes), headache, seizures, hypertension, diabetes mellitus, dyslipidemia, obstructive sleep apnea (OSA), ischemic heart disease, atrial fibrillation, smoke, weight, height, body Mass Index (BMI), sedentariness, current use of estrogens and progestins, hyperhomocysteinemia, previous head injury, previous neurosurgery, previous blood transfusion, comorbidities, current medical therapy.

    • Data related to the index event will be collected: symptomatic or asymptomatic patient; type of index event, date of index event, age of onset, mRS for symptomatic patients.
    • Socio-demographic data will be also collected (age, gender, birth date, age at the first visit, date of the visit, race, level of education).
  2. Qualitative data Semi-structured interviews will be developed and perform at T1 to obtain feedback from the end users (patients and/or caregivers) of the DT to understand their user experience.

Qualitative analysis of user experiences will be the main focus. The NVivo software will be used to identify topics and perform advanced queries.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Michigan
      • Milan, Michigan, Italy, 20133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard secondary prevention + digital twin
Patients allocated to this arm will receive the standard secondary prevention and will also use the STRATIF-AI app, which will integrate digital twin (DT) technology to improve patient management during the secondary prevention phase and to assist patients in understanding key concepts, such as: "Why should I care about a certain risk factor (e.g. blood pressure), and how can my lifestyle impact that risk factor? In other words, they will use the app to understand their medical situation, and to set personal goals.
Device: AI
STRATIF-AI apps will be used as an integral part of the dialogue with patients during thesecondary prevention phase
Active Comparator: Standard secondary prevention only
Patients allocated to this arm will receive only standard secondary prevention, which includes typical treatments and monitoring protocols used for patients with stroke, Moyamoya disease, and CAA.
Other: healthy dialogue
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback from users
Time Frame: 12 months
To get initial feedback on the patients' experience regarding the use of the STRATIF-AIplatform in the secondary prevention phase.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
feedback to developers
Time Frame: 12 months
feedback to development team. This will be used as a starting point for future studiesand for conversations with other clinics, politicians, and policy maker.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

November 7, 2024

First Submitted That Met QC Criteria

December 2, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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