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 | Recruiting

• 1 other identifier: SMART
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke; Moyamoya Disease; Cerebral Amyloid Angiopathy

Keywords

stroke; secondary prevention; digital twin; Moyamoya Disease; Cerebral Amyloid Angiopathy

Outcome Measures

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.

  12 months

Secondary Outcomes (1)

• feedback to developers

  12 months

Study Arms (2)

Standard secondary prevention + digital twin

EXPERIMENTAL

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

Standard secondary prevention only

ACTIVE COMPARATOR

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

Interventions

AI DEVICE

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

Standard secondary prevention + digital twin

healthy dialogue OTHER

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

Standard secondary prevention only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Michigan, 20133, Italy

RECRUITING

Related Publications (4)

• Elkefi S, Asan O. Digital Twins for Managing Health Care Systems: Rapid Literature Review. J Med Internet Res. 2022 Aug 16;24(8):e37641. doi: 10.2196/37641.

  PMID: 35972776 RESULT

• Herrgardh T, Madai VI, Kelleher JD, Magnusson R, Gustafsson M, Milani L, Gennemark P, Cedersund G. Hybrid modelling for stroke care: Review and suggestions of new approaches for risk assessment and simulation of scenarios. Neuroimage Clin. 2021;31:102694. doi: 10.1016/j.nicl.2021.102694. Epub 2021 May 7.

  PMID: 34000646 RESULT

• Marwaa MN, Guidetti S, Ytterberg C, Kristensen HK. Using experience-based co-design to develop mobile/tablet applications to support a person-centred and empowering stroke rehabilitation. Res Involv Engagem. 2023 Aug 24;9(1):69. doi: 10.1186/s40900-023-00472-z.

  PMID: 37620982 RESULT

• Prust ML, Forman R, Ovbiagele B. Addressing disparities in the global epidemiology of stroke. Nat Rev Neurol. 2024 Apr;20(4):207-221. doi: 10.1038/s41582-023-00921-z. Epub 2024 Jan 16.

  PMID: 38228908 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Stroke; Moyamoya Disease; Cerebral Amyloid Angiopathy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Carotid Artery Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Matilde Leonardi, MD

CONTACT

+39 02 2394 2511; matilde.leonardi@istituto-besta.it

Barbara Maistrello

CONTACT

+39 02 2394 2521; barbara.maistrello@istituto-besta.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: December 3, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)