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DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization

NCT05904288 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2024-10-17

No results posted yet for this study

Summary

The study is aimed at developing Digital Therapeutics (DTx) algorithms for personalized PD treatment and medication plan optimization, based on Real World Data (RWD) collected from patients via digital mobile app and wearable sensors.

The study design is observational/noninterventional, prospective, single-arm, aimed at collecting data from wearable sensors for validation of symptom detection algorithms, through (1) a supervised in-clinic motor assessment, performed using validated clinical scales (Visit 3, Visit 4), and (2) an unsupervised, home-based, 6-month (Visit 3 to Visit 4) data collection from wearable devices (passive monitoring) for algorithm cross-validation using patient reported outcomes (PROMs) and remote clinical assessments. The devices used in the study will be a commercial smartwatch (Garmin Vivosmart 5) for inertial data collection and a digital application through which subjects will report PROMs via a digital symptom diary. Screening visits (Visit 1 and Visit 2) will be conducted prior to enrollment to verify eligibility criteria through clinical assessments, the subjects' symptom diary, and by assessing adherence to the use of the study tools provided (i.e., mobile application and smartwatch).

Conditions

  • Parkinson Disease

Interventions

DEVICE

Smartwatch Garmin Vivosmart [wearable sensor]

Garmin Vivo Smart is a fitness tracker, which is aimed at collecting patient's motor activity and heart rate data from embedded Inertial Movement Unit (IMU) and Photoplethismograph (PPG) sensors.

DEVICE

Soturi™ [digital mobile app]

Soturi software is a proprietary mobile application, for people with Parkinson's Disease (PD) designed to record symptoms, by means of self-report diary, set reminders for medication intake. Soturi™ Physical Exercise Program and Speech Exercise Program.

OTHER

Clinical Assessment

Outpatient repeated-measures clinical evaluations, which include assessment of motor symptoms through MDS-UPDRS and ecological motor tasks, to observe changes with respect to medication intake, and changes over a 6 month period time.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Mediolanum Cardio Research

    collaborator OTHER

  • Newel Health SRL

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-10-15
Completion
2024-10-15

Countries

  • Italy

Study Locations

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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 NCT05904288 on ClinicalTrials.gov