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Unobtrusive, Continuous and Quantitative Assessment of Parkinson’s disease: Hard Evidence for Optimal Disease Management with Information Technologies

Periodic Reporting for period 4 - PARK-IT 2.0 (Unobtrusive, Continuous and Quantitative Assessment of Parkinson’s disease: Hard Evidence for Optimal Disease Management with Information Technologies)

Reporting period: 2019-02-01 to 2019-07-31

Parkinson’s disease (PD) is a neurodegenerative disorder that affects 6.3 million people worldwide and has a debilitating effect on its sufferers. It is well known that PD causes problems in movement, and sometimes complete freezing, as well as hidden non-motor symptoms that are the cause of confusion and speech difficulties. What is less known is that these symptoms come and go during the day (periods ON and OFF).

Current treatments are based on the identification and fluctuations of ON and OFF for a patient. The use of ICT tools for measuring disease progression in PD has become an emerging research topic during recent years. However, none of the available technologies have been able to show an effective approach to diagnose and follow the disease status and, subsequently, have been unable to provide personalized and appropriate treatment.

PARK-IT project develops a wearable device that is placed on the patient’s waist within a comfortable belt. Firstly, using a set of sensors, advanced algorithms and signal processing methods, this device identifies and records the patient’s PD motors symptoms (ON/OFF fluctuations, among others). Secondly, when this information is collected and thanks to a mobile application, the information is accessible to patients and their health care professionals. The knowledge provided by the device helps doctors and patients to make informed and improved decisions on how to treat the individual’s changing PD.

PARK-IT’s device is the first available on the market that allows a reliable, extensive, continuous, direct, interoperable, and cost- effective monitoring of PD in ambulatory conditions. Now, PARK-IT provides quantitative insights to inform patients and their health professional about their PD status and evolution in ambulatory conditions.

The overall objectives to be achieved by the PARK-IT 2.0 project are:
• To redesign the current device and app in order to obtain a ready-to-market version and its industrialization plan.
• To obtain the certification of the solution as a medical device (Class IIa).
• To build actions (promotion, participation in pilots…) in order to promote the use of the device as a PD monitor, and create awareness of its benefits to PD’s patients, neurologists, and distributors.
• To be able to launch the solution to the European market by the end of 2019.

As a conclusion after the end of the project, three main conclusions can be announced:

• All the objectives have been achieved with success.
• The new device, with the commercial name STAT-ON has been certified as medical device Class IIa and has been launched to the European market
• 500 devices have been manufactured and used mainly for diffusion and promotion.
At the beginning, main objective of the project was the complete re-design of the device. The specifications for both the sensor device and the Apps (Android and iOS versions) were set during this phase. This resulted in the following activities:

• Design of the electronic board of the sensor device.
• Design of the housing that contains the electronic board and the battery.
• Selection of the wireless charger to be used for the sensor device.
• Development of the firmware for the sensor device.
• Development of the necessary apps.
• Design of the belt to be used for the allocation of the device.

As a result of these activities, at the end of the first reporting period 15 units of the new system were available and ready to be used in the user test pilot to be carried out during the second period of the project.

Another important activity within this Work Package consisted in the definition of the experimental protocol, the patient’s informed consent and the Case Report Form to be used in the user test pilot. This information was presented to the corresponding Ethical Committee, and permission for the study was granted. A price sensitivity study for the obtained device was carried out, giving a first idea to develop the future commercialization strategy and business plan.

The activity related to the second reporting period started with the organization and execution of the announced Usability pilot activity, with the main objectives placed in the detection of problems of use and acceptability by the final users. This second period encountered a series of unexpected problems coming from the redesign done during the First period that was necessary to concretely identify, address, fix and solve. After some delay in the evolution of the execution of the project, all the issues were correctly addressed at that given time.

The third period of activity in the project was concentrated, as it was announced along the documentation related to the second activity period, to the proper solution of encountered problems and the correct management of the works to be done till the end, according a new Amendment of the contract that was recommended and suggested by the reviewer in their conclusions.

Below, some important points are listed, in accordance with the issues explained in the documentation submitted in the different reviews and the contents of the Amendment of the contract signed by the end of January 2019. An overview of important results is also included.

• An Amendment of the contract was prepared and signed, modifying the total duration of the project to 30 months.
• Some of the pending responsibilities and management of still pending tasks were completely assumed by Sense4Care. This included the manufacture and test quality for the production of the samples to be used in the WP3.
• The certification process (mainly WP2) was concluded, with some delay introduced by external reasons. The final device, with the commercial name STAT-ON got the certification as medical device Class IIa and is now ready to be launched in EU market.
• Diffusion activities among health professionals and the promotion of the developed technology STAT-ON to be used in several external piloting activity to test and validate its clinical value, have been developed along WP3.
• As part of the WP3 a number of STAT-ON devices (500 in total) have been manufactured and completely distributed. The accompanying training material is available, to.
• A commercialization plan and a complete business plan (ready for investors) have been worked-on in the WP5
• The work developed in PARK-IT2.0 and the STAT-ON device have been presented and diffused along a number of fairs and events, where Sense4Care has participated. A number of related publications have been also reported..
PARK-IT 2.0 brings important technical innovations beyond the state-of-the-art:

• It is an effective solution for the continuous diagnosis and monitoring of mild to severe Parkinson’s Disease (PD). STAT-ON is the only solution that offers, in a single device, monitoring and detection of up to 5 motor symptoms.

• STAT-ON has a clear competitive technological advantage thanks to its software that is capable of carrying out an assessment of the symptoms of the patient through highly reliable AI algorithms.

• STAT-ON ensures the best level of monitoring and quality assessment of PD and a wider applicability than competitors in terms of symptoms, environment (ambulatory and home), time (continuous) and target (patients by themselves or clinical use with control of a neurologist).

• The system holds the potential to be a massive breakthrough in home care service delivery for PD patients.
Device STAT-ON
STAT-ON placed in the waist
STAT-ON overview