A small sensor, headphones and a mobile phone - the elements of a prototype kit that is giving hope of relief for sufferers of Parkinson's disease. The European-backed research project being spearheaded in Barcelona - and with an input from a team at NUI Galway headed up by Professor Gearóid ÓLaighin - does not offer a cure for the degenerative condition, but it could improve the quality of life of patients and give them more autonomy.
An initiative to help develop wearable technology incorporating smartphones, that will assist patients with Parkinson’s (PwPs) with their disease management, is almost complete. The European Union funded REMPARK initiative (short for ‘Remote Management of Parkinson’s), which began in 2011, is in the process of assessing assessing its final results following trials of the technology in Ireland, Spain, Italy and Israel.
Pere Bosch, who lives in the Catalan city, was diagnosed with Parkinson’s 16 years ago. “I used to play the accordion,” he says. “When I tried to press the buttons with the left hand, instead of being able to use my fingers and keep the rhythm, I just grasped the accordion. I just couldn’t...”
More autonomy
He is taking part in the project aimed at helping patients manage the different stages of their disease more autonomously. He wears a sensor on his waist that records movement data and identifies symptoms. When the patient lacks coordination, acoustic stimuli in the ear help him walk in a straight line. The data is also sent via mobile phone to doctors, who can follow the evolution of the disease and adapt treatment accordingly.
“The device tells us how many hours the patient’s state is ‘on’ and ‘off’, how the patient walks during these two different stages of the disease,” says Àngels Bayés, a neurologist at the Teknon Medical Centre, Barcelona, which is leading the research. “We’re also able to know if the patient suffers from blockages or not, and if so how many blockages he suffers throughout the day. We can also know how fast he can walk. When the system automatically detects that the patient has motor problems, it activates acoustic stimuli to help the patient walk better.”
The sensor was designed and developed at an electronics laboratory at the Polytechnic University of Catalonia in Barcelona. Researchers say the biggest challenge was to embed electronics and complex algorithms into a portable, functional and unobtrusive device. “Inside the sensor we have an accelerometer, that keeps track of acceleration as the person walks,” says Carlos Pérez López, an electronics engineer involved in the project.
“We also have a magnetometer, which works like a compass, recording data in the magnetic fields. And it also has a gyroscope, that records how the patient moves along in three axes in a given space. This data is recorded and analysed through mathematical algorithms. And in the end, we’re able to classify any movement the patient makes”.
Encouraging trials
Researchers say first trials have confirmed that the device can indeed help patients increase their autonomy, although Paola Quispe, a Teknon Medical Centre nurse, says patients she has worked with have suggested some minor improvements: “Most of the patients have said they would prefer smaller sensors. There’s also a gap of around one minute between the moment the sensors identify a problem and the sending of the acoustic stimulation. Patients also said they would prefer to have musical rhythms, instead of just the beat of a metronome.”
Now researchers are working on giving the device the capacity to regulate the medication the patients receive, in real-time and in response to their body’s needs, as Joan Cabestany, a telecommunications engineer and coordinator of the REMPARK project, as it is called, explains: “The next step is to transform this device into a fully operational medical aid. A device that will help doctors provide better diagnostics, and also, eventually, allow them to adapt the patients' medication, which will improve their health. But medical devices are heavily regulated in Europe, so we need to work further in this direction.”
REMPARK's research has been focused on improving self-management of Parkinson's disease through accurate and non-invasive monitoring of Parkinson's motor symptoms. The specific and ultimate goal of the REMPARK project is to develop a Personal Health System (PHS) with closed loop detection, response and treatment capabilities for management of Parkinson's Disease (PD) patients at two levels:
- At the first level, the project will develop a wearable monitoring system able to identify in real time the motor status of the PD patients, and evaluating ON/OFF/Dyskinesia status in operation during ambulatory conditions and will also develop a gait guidance system able to help the patient in real time during their daily activities.
- At a second level, the intelligent analysis of data provided by the first level, supported with a disease management system will allow the neurologist in charge to access accurate and reliable information to decide about the treatment that best suits the patient, improving the management of their disease, in particular to adjust so called therapeutic window.
To achieve this global goal, four main objectives need to be achieved:
- Identification of motor status in real time
- Development of a gait guidance system
- Development of a user interface to collect direct feedback from the patient
- Development of a server to allow interaction with the doctor in charge and track the evolution of the patient's condition.
REMPARK solution
To achieve the described objectives, a telemedicine enabled Personal Health System (PHS) will be developed for the remote management of Parkinson's Disease in its medium and advanced stages. PHS is composed by two levels: the first level corresponds to the Body Area Network (BAN) and acts in the short-term. It is composed by the sensors, the actuators and the smartphone, which also acts as GPS for providing context-aware information and as an interface for the PD patient, to record their direct feedback especially regarding the non-motor symptoms.
Communications among the elements of the BAN will be via low energy Bluetooth (4.0), allowing enough autonomy for the patient.This first level will work autonomously, constituting a closed and automatic loop. This level of the system will be auto-adaptive by means of a constant evaluation of the actuator's effect, correcting its behaviour in the short term. Different configurations are possible for different patients.
For instance, some patients may react better to auditory cueing while others may react better to haptic cueing (provided by the FES device). The use of FES as step initiating device will be an option for those patients suffering frequent episodes of FOG, while others may not need it because they do not experience FOG episodes, or because the chosen cueing system is enough to prevent the FOG episodes. The adjustable drug delivery system will be investigated and tested in subsequent medical projects and the objective is to include it for those patients suffering from unpredictable OFF periods.
The second level acts in the medium-long term and constitutes a closed semi-automatic loop, as it allows the intervention of medical professionals. The system will be able to send data to the server of the relevant health service provider, allowing the patient's neurologist to regularly follow the evolution of the patient's disease in a more effective manner, as well as being able to make better informed decisions about the adjustment of the pharmacological treatment of the patient, a key issue in management of this disease.
Data on the server will be automatically included in an Electronic Health Record (EHR). The correct intelligent data treatment will help to evaluate and predict the evolution of the disease of a particular patient.
On this specific architecture, two different groups of algorithms will be running. The first group will belocated in the level 1 (BAN), and it will be responsible for the ON/OFF detection and the implementation of the gait guidance system. A second group of algorithms will be the responsible for the implementation of the Rule engine at the server level.
Validation process
Validation is a very crucial process since it will assess whether the developed sensors and the entire system are in position to adequately address predefined requirements, especially in terms of sensitivity and specificity of the ON/OFF/Dyskinesia detection and the goodness of REMPARK actuators.
In addition, REMPARK validation process will follow the scientific method, in order to end up with scientific evidence, and so be accepted within the medical community. Validation process is divided two different kinds of testing:
- First loop of trials to be performed in Spain, on a reduced sample of PD patients, in order to assess if, eventually, any improvements on the REMPARK system performance could be needed.
- Second loop to demonstrate and test the performance of the final system prototype using the representative PD patients sample in all 4 countries.
Strategic impact
The potential impact of REMPARK infringes in three fronts: medical, social and economic benefits. Expected impacts that REMPARK will respond to, are the following:
- Reduced hospitalisation rate and improved disease management, treatment or rehabilitation at the point of need.
- Strengthened evidence base on medical outcomes, economic benefits and effectiveness of the use of Personal Health Systems.
- Reinforced medical knowledge with respect to efficient management of diseases
- Contribution to more sustainable European healthcare system, through provision of high quality, personalized care, with better use of the available healthcare resources
- Reinforced leadership and innovation capability of the industry in PHS, medical devices and services through introduction of new business models, creation of spin-offs and better exploitation of IP for products, standards and regulation
- Accelerated establishment of interoperability standards and of secure, seamless communication of health data between all involved partners, including patients
- Participation of essential stakeholders in production of end-to-end solutions for personalized care. Reinforced national or regional commitment in deployment of innovative services following R&D projects
- Improved links and interaction between patients and doctors facilitating more active participation of patients in care processes.