The CloudUPDRS Smartphone Software in Parkinson's Study. (CUSSP)
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|ClinicalTrials.gov Identifier: NCT02937324|
Recruitment Status : Unknown
Verified July 2018 by University College, London.
Recruitment status was: Active, not recruiting
First Posted : October 18, 2016
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: CloudUPDRS smartphone software assessment Other: Clinical assessment||Not Applicable|
Parkinson's Disease (PD) is a neurodegenerative condition, which when treated can result in fluctuating motor activity - sometimes too much movement, sometimes too little.
A series of tests, run on a smartphone, will be used to evaluate the motor signs of Parkinson's and related to a clinical evaluation based on the Unified Parkinson's Disease Rating Scale. 60 participants will be recruited.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The CloudUPDRS Smartphone Software in Parkinson's Study - a Pilot Dual-site, Open Label Study Comparing the Validity of Smartphone Software for Monitoring the Symptoms and Signs of Parkinson's Disease.|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Active Comparator: Clinical Assessment
Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.
Other: Clinical assessment
A clinician will assess the motor signs of the participant using the Unified Parkinson's Disease Rating Scale. The examination will be videoed and rated by 3 blinded examiners.
Experimental: Smartphone assessment
CloudUPDRS smartphone software assessment will be performed.
Device: CloudUPDRS smartphone software assessment
Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.
- Validity of smartphone software for home monitoring in Parkinson's disease [ Time Frame: 3 years ]The primary objective is to measure the validity (bias and reliability) of the smartphone UPDRS (smartphone derived UPDRS). The primary objective outcome measure is the accuracy (and error) of the smartphone UPDRS predictions of the clinical UPDRS rating score. This will be ascertained by using multiple cross-validation runs in which the data are randomly split into 'calibration' and 'testing' cohorts. The model will be trained on the 'calibration' dataset, and the accuracy and error from the out-of-sample predictions will be summarised into a mean accuracy and error score.
- Data exploration [ Time Frame: 3years ]Data from this study will be subjected to post hoc analysis to explore future hypotheses in this area.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02937324
|London, United Kingdom, WC1N 3BG|
|Principal Investigator:||Kailash Bhatia, MD||University College, London|