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

May 21, 2019 updated by: University College, London

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data exploration
Time Frame: 3years
Data from this study will be subjected to post hoc analysis to explore future hypotheses in this area.
3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Kailash Bhatia, MD, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimate)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2019

Last Update Submitted That Met QC Criteria

May 21, 2019

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/0062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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