PARK-IT

01/02/2017 – PARK -IT Project Starts

24/03/2017 – Sense4Care will be present in the Health 2.0 Europe 2017 Exhibtion

SME Instruments phase II Project PARK-IT 2.0

About the project

Parkinson’s disease (PD) is a neurodegenerative disorder that affects 6.3M 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. These periods are known as ON and OFF periods. Whit applying effective medication, the OFF periods can be significantly reduced, allowing patients to live normal and independent live.

Current treatments are based on fluctuations of ON and OFF periods, and can effectively minimize symptoms for years. However, the methods used to identify these changing periods are inaccurate and do not reflect the fact that these periods can change on a daily basis, due to two main reasons:

  1. Healthcare professionals, patients and caretakers do not follow day-to-day fluctuations in PD symptoms, because patients are examined once o or twice a year for about half an hour each time.
  2. When treating PD, neurologists use a methodology to evaluate PD progress that is based on (a) the report of the doctor during the patient’s visit; (b) the patient’s diary; and (c) standard questionnaires. This procedure leads to a series of errors, as these patient’s diaries are very subjective, because patient’s diaries are very subjective because patients self-report their status. Furthermore standard questionnaires only offer static overview, rather than a continuous and dynamic analysis.

Therefore, it is extremely difficult to accurately define the medication dosage and timing accurately in order to meet each individual’s needs perfectly. As a result, patients suffer from debilitating symptoms. Thus, they require support care, which would be unnecessary if the medication was adjusted correctly so that every patient’s need could be met. The cost of medical evaluation, inpatient and nursing home support or expenses related to the reduced productivity of care givers are estimated to represent 79% of the total treatment costs of PD (€ 13,9Bn). In Europe the treatment of PD costs € 11Bn a year on average. These costs all predominantly fall on the care givers. According to estimations, 45% of the caregivers for Parkinson’s disease are the patients’ family members who give up their paid employment in order to take care for their loved ones. In addition, Government accounts also suffer losses of billions of euros due to the lower productivity of the economy.

One way to obtain continuous results could be to observe the patient for a period of time in a hospital. But this is very expensive and can only be consider a short-term solution, since patient’s disease will have progressed after a period of months, As a result, medication will need to be adjusted, and the patient readmitted. Due to the difficulties in obtaining accurate results by examining patients over a period of time, 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.

The innovation

PARK-IT is 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 PARK-IT helps doctors and patients to make informed and improved decisions on how to treat the individual’s changing PD. Receiving the information provided by PARK-IT helps patients to:

  • Reduce the Total Cost of Care (TCOC) by 30%, resulting in an estimated treatment cost of € 3,500 per patients.
  • Improve treatment, allowing the patients to live a higher quality and more independent life.

Previously, it has not been possible to continuously monitor a patient’s ON and OFF periods in real time. So far, current solutions have focused on analyzing PD’s specific symptoms, rather than paying attentions to ON/OFF fluctuations. Furthermore, they are based on the reports made by the patients.

PARK-IT is the first device 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.

Objectives

The overall objectives of PARK-IT 2.0 Phase II project are:

  • Redesing the current PARK-IT device and app in order to obtain a ready-to-market version and its industrialization plan.
  • Obtain certification of PARK-IT as a medical device (Class IIa).
  • Building a demostration pilot in order to promote the use of PARK-IT as a PD monitor, and creating awareness of its benefits to PD’s patients, neurologists, and distributors.
  • Launch PARK-IT 2.0 to the European market by Q3-2019 , and make it a commercial success.
  • Improve the quality of life of PD patients, and reduce the economic social impact of PD by 30%.

The solution

The PARK-IT solution is composed of 3 main parts:

  • A small device that, worn in the patient’s waist with a comfortable and especially designed waist belt, records and monitors continuously patient’s movements patterns (kinetic information). The device contains an accelerometer, a microprocessor, a rechargeable battery, and a communications unit, which is able to transfer the motor assessment results to an external mobile device (smartphone or tablet).
  • Advanced algorithms and signal processing methods embedded in the device are used to analyse the collected information, and indetify and assess when the patient has specifc PD symptoms, including : bradykinesia, dyskinesia, freezing of gait (FoG), ON/OFF fluctuations, falls, posture transitions and physical activity. Thus, the intelligence built into the system will allow to accurately determine – in real time and in ambulatory conditions – user’s motor symptoms and trigger courses of action, such as enabling the actuators to help the user overcome gait disturbance.
  • A mobile application software (iOS and Android) that, from de data provided by the sensor, creates the assessment reports for the patient that are presented on screen with a clean layout and also sent by e-mail to the person the patient configures to receive them, providing a quick overview of the patient status over a prescribed period of time. The mobile application is also in charge of managing the communication with the sensor.

Based on this symptom evaluation, PARK-IT has three main applications:

  • Patient empowerment through detailed monitoring of the symptoms.
  • Disease management. PARK-IT is able to provide an overall assessment of the patient’s motor state (ON/OFF) fluctuations, and therefore the neurologist can perform informed an effective disease management, especially regarding adjustment of medication type and dose, a key issue in the management of PD. This concept has already raised the interest of public and private healthcare service providers. On the other hand, the information provided by the PARK-IT device may help the patient to better organise daily activities and, therefore, improve his/her quality of life.
  • Parkinson’s studies and clinical trials. PARK-IT is also fit for its use in clinical trials to effectively assess the outcomes of new treatments or medications. Several Pharma companies and R&D actors has expressed an interest (Expressions of Interest are attached in Section 4), particularly regarding long term studies.

Impact

PARK-IT works with neurologists and their Parkinson’s patients to improve the effectiveness of their medication, their quality of life, and reduce the overall costs of care.

There are 6.3M people with PD worldwide, all of them are potential users of PARK-IT, and 1.2M of whom living in Europe. It is estimated that about 1-2% of people over 65 years are affected by the disease. PD is expected to double in 2030 due to aging and demographic change, particularly in Europe, Japan and North America. Although it is associated with older age groups, 10% are affected before the age of 50 years.

The Hoehn and Yahr (H&Y) scale rates 1-to-5 the severity of the PD, and defines three main groups of patients corresponding to mild (C), moderate (B) and advanced (A) stages. In Europe there are 684.000 patients at the mild stage C (57%), 420.000 moderate stage B (35%) and 96.000 at the advanced stage A (8%). The care needs of PD are different according to the stage of disease progression. As PD patient’s disease progresses, it becomes increasingly difficult to live an independent, quality and fulfilled life. PARK-IT’s value to these patients is simple, but vital because it ensures that the medication is effective when the patient needs it, and it allows PD patients to live independently, and improves quality lives for longer.

PARK-IT targets to PD patients in the moderate (B) and late mild stage (C), as they are the ones that already presented some symptoms related to motor disorders. In total these segments reach 625k of the 1.2M PD patients in Europe, growing at 8% annually. Globally, the total will reach over 15,5M by 2022.

Project structure

The project has been structured around six workpackages:

  • WP1 -Redesign os the PARK-IT commercial version (M1 – M14)
  • WP2 – Certification and standarisation (M9 – M24)
  • WP3 – PARK-IT demonstration pilot (M14 – M24)
  • WP4 – Communication and dissemination (M1 – M24)
  • WP5 – IPR, commercialisation strategy and business relevance (M1 – M24)
  • WP6 – Management (M1 – M24)
Project Name Unobtrusive, Continuous and Quantitative Assessment of Parkinson’s disease: Hard Evidence for Optimal Disease Management with Information Technologies
Project Acronym PARK-IT 2.0
Project Reference 756861
Total cost: 998.510,50 €
EC funding: 698.957,35 €
Project start date 1/2/2017
Project duration 24 months
Project Coordinator Sense4Care
Contact Person J. Manuel Moreno
Tirso de Molina, 36 – 08940 Cornella de Llobregat, Spain.

Tel. (+34) 934923959 / (+34) 608023505

E-mail: j.manuel.moreno at sense4care.com