The CloudUPDRS Smartphone Software in Parkinson's Study.

NCT02937324 | Unknown

• 1 other identifier: 16/0062
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Data exploration

  3years

Study Arms (2)

Clinical Assessment

ACTIVE COMPARATOR

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

Other: Clinical assessment

Smartphone assessment

EXPERIMENTAL

CloudUPDRS smartphone software assessment will be performed.

Device: CloudUPDRS smartphone software assessment

Interventions

CloudUPDRS smartphone software assessment DEVICE

Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.

Smartphone assessment

Clinical assessment OTHER

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.

Clinical Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Ashwani Jha

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kailash Bhatia, MD

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: October 18, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: May 23, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)