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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)

NCT06714097 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-30

No results posted yet for this study

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

Conditions

  • Stroke
  • Moyamoya Disease
  • Cerebral Amyloid Angiopathy

Interventions

DEVICE

AI

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

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

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06714097 on ClinicalTrials.gov