The study will include a total of 250 physiotherapists and 1000 patients. The aims of this study are: (1) to perform *big data* analyses on the raw sensor data, in relation to concurrently acquired clinical data in these patients (limited version of…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study endpoints include parameters registered with the smartwatch, the pendant
movement sensor, and collected with the PPMI assessment. The data from the
smartwatch is processed into parameters for the amount of time active during
the day and the number of steps per day. If the ongoing work in develop
algorithms is successful, it may become possible to predict ON/Off levels,
bradykinesia, dyskinesia and rigidity. The number of falls will be registered
with the pendant movement sensor (necklace). Medication intake and mood are
registered using an app on the Smartphone. Finally, the PPMI assessment
includes assessment of motor symptoms, cognition, depression, sleep and daily
activity.
Secondary outcome
not applicable
Background summary
Today*s management of patients with a chronic disorder like Parkinson*s disease
(PD) is imperfect. Our understanding of clinical profiles is based on
observations in small, selective populations with brief follow-up. Moreover,
treatment decisions are based on averaged population results that may not apply
to a specific individual context. These drawbacks will be addressed with a *big
data* approach. Ambulatory sensors will be used as an objective measure of
patients* performance under everyday circumstances, for longer periods of time.
We aim to explore the potential of using longitudinal ambulatory data to enrich
a standardized clinical dataset, which reflects current clinical practice for
the assessment of disease status.
Study objective
The study will include a total of 250 physiotherapists and 1000 patients. The
aims of this study are: (1) to perform *big data* analyses on the raw sensor
data, in relation to concurrently acquired clinical data in these patients
(limited version of the PPMI protocol); and (2) to correlate the ambulatory
sensor data to simple self-assessments made during follow-up.
Study design
Observational longitudinal cohort study.
Study burden and risks
Using the ambulatory devices data will be recorded 24/7, for a total duration
of 13 weeks. Participants will wear the devices continuously, during 13 weeks.
Second, data from watch and smartphone app will be transmitted to a data
platform developed and managed by Intel, on behalf of the Michael J. Fox
Foundation for Parkinson`s Research. Data from the movement monitor and the
fall diary will be transmitted to Philips. Only coded data will be transmitted
to the Intel*s and Philips platform.
To access those data, researchers can grant permission for research purposes,
provided by these companies. Accordinly, patients will be asked for permission
to share the raw data in a coded form for dissemination to the research
community, analysis and use in future publications. Only data of those patients
that provided written permission will be used accordingly. This approach does
not give a breach of privacy.
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
Dutch Parkinson patients
- Male or female
- Age 30 years or older at time of PD diagnosis
- Subjects must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting
tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International
Conference on Harmonization (ICH), and local regulations
Exclusion criteria
Little or no response to adequate doses of levodopa or a dopamine agonist
- Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic
disorders (e.g., Wilson*s disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy)
- A clinical diagnosis of dementia as determined by the investigator
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might
preclude participation
- Previously obtained CT MRI scan is suggestive of another cause of parkinsonism, or with evidence of clinically
significant other neurological disorder (in the opinion of the investigator)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL53034.091.15 |