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The CloudUPDRS Smartphone Software in Parkinson's Study. (CUSSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University College, London

Brief Summary:
This study compares the validity and usability of smartphone software for home monitoring of symptoms and signs in Parkinson's disease as compared to the current clinical gold standard - the Unified Parkinsons Disease Rating Scale.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: CloudUPDRS smartphone software assessment Other: Clinical assessment Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Data exploration [ Time Frame: 3years ]
    Data from this study will be subjected to post hoc analysis to explore future hypotheses in this area.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988).
  2. Over 18 years old.
  3. Achieve >20/30 on the Montreal Cognitive Assessment (MOCA).
  4. They must have been on the current Parkinson's Disease medication schedule for at least a week and have no plans to change this during the period of testing.
  5. They must have the capacity to consent to take part in the study.
  6. They must be able to understand English to the level of being able to operate the phone software, follow its instructions and be able to answer the study questions.

Exclusion Criteria:

  1. Acute medical illness.
  2. Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study.
  3. Unable to consent to the study.

Information from the National Library of Medicine

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


Locations
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United Kingdom
Ashwani Jha
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Investigators
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Principal Investigator: Kailash Bhatia, MD University College, London
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02937324    
Other Study ID Numbers: 16/0062
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases