NCT05904288Completed
DTx Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
Development of Digital Therapeutics Algorithms for Personalized Parkinson's Disease Treatment and Medication Plan Optimization
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 54 (actual)
- First submitted
- 8 May 2023
- Start date
- 10 Oct 2023
- Primary completion date
- 15 Oct 2024
- Lead sponsor
- Newel Health SRL
- Diseases
- Parkinson disease
- NCT number
- NCT05904288
What you commit to
- Study type: Observational
- Participants enrolled: 54
- From 10 Oct 2023 to the primary completion date, 15 Oct 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant participation to clinical trials with investigational medicinal products.
Other illness
- 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.
- 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.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Fondazione Santa Lucia Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS San Raffaele Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.