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

Primary Purpose

Parkinson's Disease

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
CloudUPDRS smartphone software assessment
Clinical assessment
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ashwani Jha

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Clinical Assessment

Smartphone assessment

Arm Description

Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.

CloudUPDRS smartphone software assessment will be performed.

Outcomes

Primary Outcome Measures

Validity of smartphone software for home monitoring in Parkinson's disease
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.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2016
Last Updated
May 21, 2019
Sponsor
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02937324
Brief Title
The CloudUPDRS Smartphone Software in Parkinson's Study.
Acronym
CUSSP
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 Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Clinical Assessment
Arm Type
Active Comparator
Arm Description
Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale.
Arm Title
Smartphone assessment
Arm Type
Experimental
Arm Description
CloudUPDRS smartphone software assessment will be performed.
Intervention Type
Device
Intervention Name(s)
CloudUPDRS smartphone software assessment
Intervention Description
Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.
Intervention Type
Other
Intervention Name(s)
Clinical assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Validity of smartphone software for home monitoring in Parkinson's disease
Description
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.
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Data exploration
Description
Data from this study will be subjected to post hoc analysis to explore future hypotheses in this area.
Time Frame
3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with probable idiopathic Parkinson's Disease according to Brain Bank criteria (Gibb and Lees, 1988). Over 18 years old. Achieve >20/30 on the Montreal Cognitive Assessment (MOCA). 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. They must have the capacity to consent to take part in the study. 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: Acute medical illness. Any other co-morbidity that in the opinion of the Investigator may preclude their participation in the study. Unable to consent to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kailash Bhatia, MD
Organizational Affiliation
University College, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ashwani Jha
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The CloudUPDRS Smartphone Software in Parkinson's Study.

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