This is another fine example of how smartphones could be used to good effect in modern day medicine. Roche Pharma Research & Early Development (pRED) has developed a smartphone-based monitoring system for those with Parkinson’s disease (PD) that complements the traditional physician-led assessments with automated tests that continuously measure their symptom fluctuations. This could be the first time that such an app has been used to measure disease and symptom severity in a medicine development program in Parkinson’s disease.
“The app is being used in a Phase I trial run by Prothena, in collaboration with Roche in PD. In clinical trials in this area, disease disability and impairment are traditionally measured by physician assessments using the Unified Parkinson’s Disease Rating Scale (UPDRS). However, these are limited to the specific times that patients go for an appointment with their physicians. The app will enable continuous measurement of PD fluctuation every day and throughout the day. Ultimately, we hope the app can be used in future clinical development to enable more objective measures on response to treatment to complement doctor assessments,” explains Anirvan Ghosh, Head of Neuroscience Discovery for pRED.
Patients will be asked to follow a daily routine with the app, using it every day for the duration of the trial. The routine will consist of six active tests followed by passive monitoring. These assessments are designed to provide information on a person’s symptoms, their progress and impact on daily life. The app has been developed in consultation with Max Little, a pioneer in PD app development who is best known for his work on the Parkinson’s Voice Initiative. Max is Assistant Professor at Aston University and is associated with Oxford University and the MIT Media Lab. The project has also been presented to the Michael J. Fox Foundation for Parkinson’s Research.
A series of Roche activities
“The data collected will be used to predict patient UPDRS scores and study symptom fluctuations throughout the duration of the trial. In addition, patient adherence data will be used to assess the patient’s willingness to adopt technology which will be beneficial for future trials,” says Christian Czech, Group Leader in Neuroscience Biomarker Experimental Medicine, pRED.
The active tests will ask patients to do a series of 30-second long activities. These include:
- Voice test: conducting an “aaah” sound for as long as possible
- Balance test: standing still
- Gait test: walking 20 yards, including an 180 degree turn
- Dexterity test: tapping two buttons alternately on the touchscreen with the dominant use hand
- Rest tremor test: holding the smartphone in the hand most affected by the tremor, resting it on the lap and counting back from 100
- Postural tremor test: holding the smartphone in the same hand, outstretched
For passive monitoring, patients are asked to carry the smartphone with them throughout the day. Data is then collected from the various smartphone sensors. Patients will be asked to use the app for the duration of the trial, including screening, dosing and follow-up, which may last up to a period of about 32 weeks.
Key role of investigators
The app is equipped with dashboards that show the patient’s compliance level. Based on this information, investigators can guide patients to use the app more regularly. Additionally, we can also monitor how much data is coming in from the smartphones. Based on this, we can ask investigators to speak with patients who should be using the app more regularly,” points out Christian Gossens, Head of Early Development Workflows, pRED Informatics.
The app has been developed for Android and it has been deployed to the trial on a Samsung Galaxy S3 Mini. Roche provides patients with dedicated, preconfigured smartphones for the sole purpose of remote patient monitoring via the app. This makes the device and the app easier to use for the elderly patient population.
Speaking about the project, Max Little said, “It was clear that Roche had the vision to recognise the value and potential of this technology, and the resources to make this a reality. It has been an exciting experience to see the concept take shape over the last couple of years.”