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

NCT05904288 | Completed

• 1 other identifier: NWL-SOT-CS-001
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (4)

• Change in MDS-UPDRS Part III score from baseline to the 6-month follow-up visit, as measured during in-clinic visits.

  Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III includes 33 items to assess severity of motor symptoms, scoring per each item goes from 0= normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Total score ranges from 0 to 132.

  Baseline to Week 26

• Performance of the machine learning algorithm in predicting MDS-UPDRS Part III scores based on accelerometer data collected during in-clinic visits and home-based unsupervised data collected over 6 months.

  To develop and test machine learning model's performance outcome in predicting the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor symptoms scores.The specific outcome metrics and the respective units used to evaluate the models cannot be defined in advance, as they will depend on the nature of the data and the method of analysis as described by Giannakopoulou,et al. 2022 (Internet of Things Technologies and Machine Learning Methods for Parkinson's Disease Diagnosis, Monitoring and Management: A Systematic Review. Sensors, 22(5), 1799)

  Baseline to Week 26

• Change in patient-reported motor symptoms, as measured by an electronic symptoms diary, from baseline to the 6-month follow-up visit.

  "Change in Patient-Reported Motor Symptoms" focuses on assessing changes in motor symptoms reported by patients using an electronic symptoms diary, from baseline to the 6-month follow-up visit. Patients self-report their motor symptoms through the electronic diary, which allows them to record their symptoms and their severity, duration, and frequency.

  Baseline to Week 26

• Performance of the machine learning algorithm in predicting patient-reported symptom scores based on accelerometer data collected during in-clinic visits and home-based unsupervised data collected over 6 months

  To develop and test machine learning model's performance outcome in predicting patient-reported symptom scores. The specific outcome metrics and the respective units used to evaluate the models cannot be defined in advance, as they will depend on the nature of the data and the method of analysis as described by Giannakopoulou,et al. 2022 (Internet of Things Technologies and Machine Learning Methods for Parkinson's Disease Diagnosis, Monitoring and Management: A Systematic Review. Sensors, 22(5), 1799)

  Baseline to Week 26

Secondary Outcomes (13)

• Change in MDS-UPDRS Total Score and sub-scale total scores (Parts I-II-IV)

  Baseline to Week 26

• Change in PDQ-39 Total Score

  Baseline to Week 26

• Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)

  Baseline to Week 26

• Change in Levodopa Medication Plan: Medication Dose Strength

  Baseline to Week 26

• Change in Levodopa Medication Plan: Units

  Baseline to Week 26

Other Outcomes (3)

• Usability of Soturi mobile app: System Usability Scale (SUS)

  Baseline to Week 26

• Usability of Soturi Mobile App: Session Duration

  Baseline to Week 26

• Usability of Soturi Mobile App: Frequency of App Interactions"

  Baseline to Week 26

Study Arms (1)

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.

Device: Smartwatch Garmin Vivosmart [wearable sensor]; Device: Soturi™ [digital mobile app]; Other: Clinical Assessment

Interventions

Smartwatch Garmin Vivosmart [wearable sensor] DEVICE

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.

Arm 1

Soturi™ [digital mobile app] DEVICE

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.

Arm 1

Clinical Assessment OTHER

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.

Arm 1

Eligibility Criteria

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

Study Population

The study targets individuals diagnosed with idiopathic PD which experience wearing-off phenomena.

You may qualify if:

• Written informed consent (IC) obtained.
• Age \> 18 years.
• Male or female patients Meeting the MDS clinical diagnostic criteria for Parkinson's Disease (Postuma et al., 2015)
• At least one motor symptoms OFF-period each day, excluding early morning akinesia.
• On treatment with Levodopa
• Stable Levodopa regimen for 4 weeks before Screening Visit;
• Levodopa Equivalent Daily Dose (LEDD) \> 400 mg, OR Levodopa Intake \> 2 administration/day;
• The subject is willing and able to attend study procedures and to use wearable and mobile devices.

You may not qualify if:

• Secondary or atypical PD.
• Cognitive problems which significantly impair his/her ability to give an IC and perform the study tasks.
• Levodopa Equivalent Daily Dose (LEDD) \> 800 mg, OR Levodopa intake \> 8 administration/day;
• 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.
• Concomitant participation to clinical trials with investigational medicinal products.
• 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).

Sponsors & Collaborators

• Newel Health SRL: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• Mediolanum Cardio Research: collaborator

Study Sites (3)

Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona

Salerno, Salerno, 84100, Italy

Location

IRCCS San Raffaele

Roma, 00163, Italy

Location

IRCCS Fondazione Santa Lucia

Roma, 00179, Italy

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 15, 2023
• Study Start: October 10, 2023
• Primary Completion: October 15, 2024
• Study Completion: October 15, 2024
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)