Parkinson's DiseaseCUSSPNCT02937324
The CloudUPDRS Smartphone Software in Parkinson's Study.
A study testing CloudUPDRS smartphone software assessment and Clinical assessment in people with Parkinson's Disease, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- CloudUPDRS smartphone software assessment and Clinical assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- CloudUPDRS smartphone software assessment, Clinical assessment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudUPDRS smartphone software assessmentDevice
Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.
Clinical assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Assessment | Active comparator | Motor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale. Receives: Other: Clinical assessment |
| Smartphone assessment | Experimental | CloudUPDRS smartphone software assessment will be performed. Receives: Device: CloudUPDRS smartphone software assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kailash Bhatia, MD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937324
- Sponsor's protocol ID
- 16/0062
- Acronym
- CUSSP
- Status last verified
- Jul 2018
- First submitted
- 14 Oct 2016
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02937324
- Acronym / sponsor ID
- CUSSP / 16/0062
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Assessment | Active comparator | Other: Clinical assessmentMotor assessment will be performed by a clinician using the Unified Parkinson's Disease Rating Scale. |
| Smartphone assessment | Experimental | Device: CloudUPDRS smartphone software assessmentCloudUPDRS smartphone software assessment will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CloudUPDRS smartphone software assessmentSmartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS. | Device | Smartphone assessment |
| Clinical assessmentA 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. | Other | Clinical Assessment |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kailash Bhatia, MD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CloudUPDRS smartphone software assessment and Clinical assessment in people with Parkinson's Disease, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of smartphone software for home monitoring in Parkinson's disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.