REAL_PD: development of clinical prognostic models for Parkinson*s disease from large-scale wearable sensor deployment and clinical data - a population-based trial

REAL_PD: development of clinical prognostic models for Parkinson*s disease from large-scale wearable sensor deployment and clinical data - a population-based trial - REAL_PD trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42375

Enrollment

1000

Registered

2015-07-13

Start date

2015-08-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsons disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results