DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
NCT ID: NCT05904288
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
54 participants
OBSERVATIONAL
2023-10-10
2024-10-15
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Arm 1
The study group will receive noninvasive, in-depth clinical assessments similar in frequency to monitoring pertinent to normal clinical practice aimed at people with Parkinson's disease. In addition, within the mobile application provided as a gateway for data collection from the wearable sensors, subjects will also have the ability to access a library of video-recorded exercises, the effect of which on symptom modification, however, is not the subject of this investigation.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Age \> 18 years.
3. Male or female patients Meeting the MDS clinical diagnostic criteria for Parkinson's Disease (Postuma et al., 2015)
4. At least one motor symptoms OFF-period each day, excluding early morning akinesia.
5. On treatment with Levodopa
6. Stable Levodopa regimen for 4 weeks before Screening Visit;
7. Levodopa Equivalent Daily Dose (LEDD) \> 400 mg, OR Levodopa Intake \> 2 administration/day;
8. The subject is willing and able to attend study procedures and to use wearable and mobile devices.
Exclusion Criteria
2. Cognitive problems which significantly impair his/her ability to give an IC and perform the study tasks.
3. Levodopa Equivalent Daily Dose (LEDD) \> 800 mg, OR Levodopa intake \> 8 administration/day;
4. Any condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the subject if he/she takes part in the study.
5. Concomitant participation to clinical trials with investigational medicinal products.
6. Failure to show, in opinion of the investigator, acceptable/appropriate use of wearable and mobile device (e.g. weekly average daily wearable wear time \< 8 hours).
Having an advanced treatment (including Deep Brain Stimulation, Apomorphine, Duodopa), is not an exclusion criterion, as well as the subject decision or capability to attend the exercise and speech training programs within the mobile app.
18 Years
ALL
No
Sponsors
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Michael J. Fox Foundation for Parkinson's Research
OTHER
Mediolanum Cardio Research
OTHER
Newel Health SRL
INDUSTRY
Responsible Party
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Locations
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Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, Salerno, Italy
IRCCS San Raffaele
Roma, , Italy
IRCCS Fondazione Santa Lucia
Roma, , Italy
Countries
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Other Identifiers
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NWL-SOT-CS-001
Identifier Type: -
Identifier Source: org_study_id
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