Parkinson DiseaseNCT05904288
DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
An observational study of Parkinson Disease, run by Newel Health SRL at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Smartwatch Garmin Vivosmart [wearable sensor], Soturi™ [digital mobile app] and Clinical Assessment
- Type of treatment
- Medical device
- How many people
- 54 participants
- Where
- 3 sitesItaly
- Study dates
- 10 Oct 2023to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study targets individuals diagnosed with idiopathic PD which experience wearing-off phenomena.
Who may be able to join
- 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, AND/OR Levodopa Intake > 2 administration/day;
- The subject is willing and able to attend study procedures and to use wearable and mobile devices.
Who cannot join
- 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, AND/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).
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
IRCCS San Raffaele
Roma, 00163
IRCCS Fondazione Santa Lucia
Roma, 00179
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona
Salerno, Salerno, 84100
About this study
Official title: Development of Digital Therapeutics Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
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
- Being tested
- Smartwatch Garmin Vivosmart [wearable sensor], Soturi™ [digital mobile app], Clinical Assessment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
Clinical AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smartwatch Garmin Vivosmart [wearable sensor]; Device: Soturi™ [digital mobile app]; Other: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: 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)
Measured: Baseline to Week 26
Secondary outcomes (13)
Change in MDS-UPDRS Total Score and sub-scale total scores (Parts I-II-IV)
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive assessment tool for Parkinson's disease. The MDS-UPDRS total scale, ranging from 0 to 199, measures the overall severity of motor and non-motor symptoms, with higher scores indicating worse outcomes. The subscales include Part I for non-motor aspects, Part II for motor aspects of daily living, Part III for motor examination, and Part IV for motor complications. Higher scores in all subscales suggest a worse outcome, reflecting the severity of symptoms in different domains.
Measured: Baseline to Week 26
Change in PDQ-39 Total Score
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a validated tool used to measure health-related quality of life in individuals with Parkinson's disease. With scores ranging from 0 to 100, higher scores on the PDQ-39 indicate a worse outcome. It assesses various domains, including mobility, activities of daily living, emotional well-being, stigma, social support, cognition, and communication. Higher scores reflect greater impairment and a lower quality of life, while lower scores indicate better overall well-being and functioning.
Measured: Baseline to Week 26
Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)
"Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)" focuses on assessing the changes in the daily dosages of levodopa and dopamine agonists. Levodopa and dopamine agonists are common medications used in the treatment of Parkinson's disease. The dosages of these medications are calculated using standardized conversion factors to obtain Levodopa Equivalent Daily Dosage (LEDD) and Dopamine-Agonist Equivalent Daily Dosage (DAEDD), (expressed in mg/day). This outcome aims to measure any changes in the daily dosages of these medications over the course of the study or intervention.
Measured: Baseline to Week 26
Change in Levodopa Medication Plan: Medication Dose Strength
"Change in Levodopa Medication Plan: Medication Dose Strength" focuses on assessing changes in the dose strength of levodopa medication per single intake event, measured in milligrams (mg).
Measured: Baseline to Week 26
Change in Levodopa Medication Plan: Units
"Change in Levodopa Medication Plan: Units" focuses on assessing changes in the units of levodopa medication per single intake event. The units refer to the quantity of medication taken, which can be measured in whole pills, fractions of pills, or other specified units.
Measured: Baseline to Week 26
Change in Medication Levodopa Plan: Frequency of Intakes
"Change in Medication Levodopa Plan: Frequency of Intakes" focuses on assessing changes in the frequency of intakes for a specified levodopa medication. The frequency refers to the total number of times the medication is taken in a day. Levodopa is a commonly prescribed medication for managing Parkinson's disease symptoms. This outcome aims to capture any modifications made to the frequency of intakes during the study or intervention period.
Measured: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: duration
"Change in Motor Symptoms Digital Biomarkers: duration" refers to the measure of time spent with specific motor symptoms. The duration is typically measured in minutes or seconds, representing the length of time an individual experiences the motor symptom being monitored. This outcome aims to capture any changes or fluctuations in the duration of motor symptoms over the course of the study or intervention.
Measured: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: frequency
"Change in Motor Symptoms Digital Biomarkers: frequency" focuses on measuring the frequency of motor symptoms experienced by individuals. The frequency is typically recorded as the number of occurrences within a specific time period, such as per hour or per day.
Measured: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: severity
"Change in Motor Symptoms Digital Biomarkers: severity" involves assessing the severity of motor symptoms using digital biomarkers on a scale ranging from 0 to 4.
Measured: Baseline to Week 26
Digital Biomarkers: Activity
"Change in Digital Biomarker: Activity" measures the time spent on specific motor activities, such as walking, standing, active not moving, running, and climbing stairs, using digital biomarkers. The duration is measured in minutes and captures changes in activity time throughout the study or intervention.
Measured: Baseline to Week 26
Change in ePROMs: symptoms frequency
"Change in ePROMs: Symptoms Frequency" uses the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the frequency of symptoms. Participants report the frequency of specific symptoms they experience over time using the app.
Measured: Baseline to Week 26
Change in ePROMs: symptoms severity
"Change in ePROMs: Symptoms Severity" utilizes the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the severity of symptoms. Participants rate the severity of specific symptoms they experience on a scale ranging from 0 (absent) to 4 (severe) using the app.
Measured: Baseline to Week 26
Change in ePROMs, reported symptoms duration
"Change in ePROMs: Symptoms Duration" involves using the symptom tracking function within the Soturi mobile app to collect electronic Patient-Reported Outcome Measures (ePROMs) regarding the duration of symptoms. Participants are asked to record the start time and end time of specific symptoms they experience using the app's symptom tracking feature.
Measured: Baseline to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Oct 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newel Health SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Mediolanum Cardio Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904288
- Sponsor's protocol ID
- NWL-SOT-CS-001
- Status last verified
- Sep 2026
- First submitted
- 8 May 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Digital Therapeutics Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
- ClinicalTrials.gov ID
- NCT05904288
- Acronym / sponsor ID
- NWL-SOT-CS-001
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Newel Health SRLIndustry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, Mediolanum Cardio Research
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | – | Device: Smartwatch Garmin Vivosmart [wearable sensor], Device: Soturi™ [digital mobile app], Other: Clinical AssessmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study targets individuals diagnosed with idiopathic PD which experience wearing-off phenomena.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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, AND/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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Arm 1 |
| 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. | Device | Arm 1 |
| Clinical AssessmentOutpatient 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. | Other | Arm 1 |
Primary outcome
Change in MDS-UPDRS Part III score from baseline to the 6-month follow-up visit, as measured during in-clinic visits.
Time frame: Baseline to Week 26
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.
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.
Time frame: Baseline to Week 26
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)
Change in patient-reported motor symptoms, as measured by an electronic symptoms diary, from baseline to the 6-month follow-up visit.
Time frame: Baseline to Week 26
"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.
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
Time frame: Baseline to Week 26
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)
13 secondary outcomes
Change in MDS-UPDRS Total Score and sub-scale total scores (Parts I-II-IV)
Time frame: Baseline to Week 26
Change in PDQ-39 Total Score
Time frame: Baseline to Week 26
Change in Levodopa and Dopamine-Agonist Equivalent Daily Dosages (LEDD, DAEDD)
Time frame: Baseline to Week 26
Change in Levodopa Medication Plan: Medication Dose Strength
Time frame: Baseline to Week 26
Change in Levodopa Medication Plan: Units
Time frame: Baseline to Week 26
Change in Medication Levodopa Plan: Frequency of Intakes
Time frame: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: duration
Time frame: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: frequency
Time frame: Baseline to Week 26
Change in Motor Symptoms Digital Biomarkers: severity
Time frame: Baseline to Week 26
Digital Biomarkers: Activity
Time frame: Baseline to Week 26
Change in ePROMs: symptoms frequency
Time frame: Baseline to Week 26
Change in ePROMs: symptoms severity
Time frame: Baseline to Week 26
Change in ePROMs, reported symptoms duration
Time frame: Baseline to Week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Newel Health SRL at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MDS-UPDRS Part III score from baseline to the 6-month follow-up visit, as measured during in-clinic visits. (time frame: Baseline to Week 26). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.