The CloudUPDRS Smartphone Software in Parkinson's Study.

Parkinson's Disease Clinical Trial

— 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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02937324
• Other study ID #: 16/0062
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: September 2019

Study information

• Verified date: July 2018
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.

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.

Locations

Country	Name	City	State
United Kingdom	Ashwani Jha	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Data exploration	Data from this study will be subjected to post hoc analysis to explore future hypotheses in this area.	3years
Primary	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.	3 years