Parkinson DiseaseBIOCLITENCT06817772
Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
An observational study of Parkinson Disease and Parkinson, run by Universidad Politecnica de Madrid at 1 site in Spain.
Trial summary
The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is: Is there a biomarkers that allows the identification of PD from healthy controls? Is there a biomarkers that can identify the severity… Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Parkinson
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2024to May 2025
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: For the PD group, an initial and final evaluation will take place at the Asociación Parkinson Madrid. For the control group, the meeting will be at the Escuela Técnica Superior de Ingenieros Industriales at Universidad Politécnica de Madrid (ETSII-UPM).
Who may be able to join
- Diagnosis of Parkinson's disease based on the UK Brain Bank criteria.
- Affiliated with Asociación Parkinson Madrid.
- Minimal or mild disease severity, defined by a Hoehn and Yahr scale score of ≤ 2.5.
- Be capable of performing the prescribed exercises independently.
- Maintain daily functioning without dependence on caregivers.
Who cannot join
- Hoehn and Yahr scale score of > 2.5.
- Have undergone deep brain stimulation, used dopamine infusion pumps, or have conditions mimicking PD symptoms (e.g., progressive supranuclear palsy, Lewy body dementia, multiple system atrophy, or other parkinsonian syndromes)
- Experience motor symptom fluctuations throughout the day.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is:
- Is there a biomarkers that allows the identification of PD from healthy controls?
- Is there a biomarkers that can identify the severity of the disease?
- Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease?
Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.
Read the detailed description
The participants must perform a set of exercises related to the MDS-UPDRS III scale and some free-living activities. These tasks must be performed wearing a smartwatch.
The activities will be done in supervised clinical and unsupervised free-living environments. The participants must perfom a baseline and a final assesment in supervised conditions and a week of free living monitoring.
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- Parkinson, Biomarkers, Home monitoring, Wearable, Smartwatch
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease group | The inclusion criterion to this group is a diagnosis of Parkinson's disease based on the UK Brain Bank criteria. | |
| Healthy control group | The inclusion criterion is participants without movement disorders. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers for the identification of PD patients
A set of biomarkers will be defined for the identification of PD patients by comparing their data with that of healthy subjects.
Measured: 1 year
biomarkers for the prediction MDS-UPDRS scores in PD patients
A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients
Measured: 1 year
Biomarkers in supervised and unsupervised conditions
A comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start9 Dec 2024
- Primary completionApr 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Asociación Parkinson Madrid
- Responsible party
- Principal investigator, Ignacio Pavón García, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06817772
- Sponsor's protocol ID
- BDPLEDEMDP-IPG-DATOS-20231030
- Other IDs
- PID2021-123708OB-I00
- Acronym
- BIOCLITE
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Polvorinos-Fernández, C. et al. Evaluating Motor Symptoms in Parkinson's Disease Through Wearable Sensors: A Systematic Review of Digital Biomarkers. Appl. Sci. 2024, 14, 10189. https://doi.org/10.3390/app142210189
Sigcha L, Polvorinos-Fernandez C, Costa N, Costa S, Arezes P, Gago M, Lee C, Lopez JM, de Arcas G, Pavon I. Monipar: movement data collection tool to monitor motor symptoms in Parkinson's disease using smartwatches and smartphones. Front Neurol. 2023 Dec 7;14:1326640. doi: 10.3389/fneur.2023.1326640. eCollection 2023.
PubMed 38148984Polvorinos-Fernandez C, Sigcha L, Centeno-Cerrato M, de Arcas G, Grande M, Marin M, Parees I, Martinez-Castrillo JC, Pavon I. Evaluation of Free-Living Motor Symptoms in Patients With Parkinson Disease Through Smartwatches: Protocol for Defining Digital Biomarkers. JMIR Res Protoc. 2025 Jul 28;14:e72820. doi: 10.2196/72820.
PubMed 40720803
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital BIOmarkers for the Assessment of Motor Status in Parkinson's Disease Patients with CLInical and ThErapeutic Application
- ClinicalTrials.gov ID
- NCT06817772
- Acronym / sponsor ID
- BIOCLITE / BDPLEDEMDP-IPG-DATOS-20231030
- Conditions
- Parkinson Disease, Parkinson
- Keywords
- Parkinson, Biomarkers, Home monitoring, Wearable, Smartwatch
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Collaborators
- Asociación Parkinson Madrid
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Feb 2025 (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 goal of this observational study is to define digital biomarkers of motor symptoms in Parkinson's disease patients using wearable devices. The main questions it aims to answer is:
- Is there a biomarkers that allows the identification of PD from healthy controls?
- Is there a biomarkers that can identify the severity of the disease?
- Is there a biomarkers with clinical and therapeutic application that can be used in clinical and free living conditions to monitor the evolution of the disease?
Participants have to perform a set of guided exercises related to the MDS-UPDRS guide and daily living tasks, in supervised and unsupervised conditions.
Detailed description
The participants must perform a set of exercises related to the MDS-UPDRS III scale and some free-living activities. These tasks must be performed wearing a smartwatch.
The activities will be done in supervised clinical and unsupervised free-living environments. The participants must perfom a baseline and a final assesment in supervised conditions and a week of free living monitoring.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease group | – | –The inclusion criterion to this group is a diagnosis of Parkinson's disease based on the UK Brain Bank criteria. |
| Healthy control group | – | –The inclusion criterion is participants without movement disorders. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For the PD group, an initial and final evaluation will take place at the Asociación Parkinson Madrid. For the control group, the meeting will be at the Escuela Técnica Superior de Ingenieros Industriales at Universidad Politécnica de Madrid (ETSII-UPM).
Key inclusion criteria (5 listed)
- Diagnosis of Parkinson's disease based on the UK Brain Bank criteria.
- Affiliated with Asociación Parkinson Madrid.
- Minimal or mild disease severity, defined by a Hoehn and Yahr scale score of ≤ 2.5.
- Be capable of performing the prescribed exercises independently.
- Maintain daily functioning without dependence on caregivers.
Key exclusion criteria (3 listed)
- Hoehn and Yahr scale score of > 2.5.
- Have undergone deep brain stimulation, used dopamine infusion pumps, or have conditions mimicking PD symptoms (e.g., progressive supranuclear palsy, Lewy body dementia, multiple system atrophy, or other parkinsonian syndromes)
- Experience motor symptom fluctuations throughout the day.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biomarkers for the identification of PD patients
Time frame: 1 year
A set of biomarkers will be defined for the identification of PD patients by comparing their data with that of healthy subjects.
biomarkers for the prediction MDS-UPDRS scores in PD patients
Time frame: 1 year
A collection of biomarkers will be calculated to predict MDS-UPDRS scores in PD patients
Biomarkers in supervised and unsupervised conditions
Time frame: 1 year
A comparation between the biomarkers defined in supervised settings versus those defined in free-living environments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- BackgroundPolvorinos-Fernández, C. et al. Evaluating Motor Symptoms in Parkinson's Disease Through Wearable Sensors: A Systematic Review of Digital Biomarkers. Appl. Sci. 2024, 14, 10189. https://doi.org/10.3390/app142210189
- Background: PubMed 38148984Sigcha L, Polvorinos-Fernandez C, Costa N, Costa S, Arezes P, Gago M, Lee C, Lopez JM, de Arcas G, Pavon I. Monipar: movement data collection tool to monitor motor symptoms in Parkinson's disease using smartwatches and smartphones. Front Neurol. 2023 Dec 7;14:1326640. doi: 10.3389/fneur.2023.1326640. eCollection 2023.
- Derived from this study: PubMed 40720803Polvorinos-Fernandez C, Sigcha L, Centeno-Cerrato M, de Arcas G, Grande M, Marin M, Parees I, Martinez-Castrillo JC, Pavon I. Evaluation of Free-Living Motor Symptoms in Patients With Parkinson Disease Through Smartwatches: Protocol for Defining Digital Biomarkers. JMIR Res Protoc. 2025 Jul 28;14:e72820. doi: 10.2196/72820.
- Related InfoLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 and Parkinson, run by Universidad Politecnica de Madrid at 1 site in Spain.
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 5 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Biomarkers for the identification of PD patients (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06817772, which also lists 3 linked publications.
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 20 Feb 2025.