A Holter for Parkinson’s Disease Motor Symptoms: STAT-OnTM (River Publishers Series in Biotechnology and Medical Research)

A new information and communication technology (ICT) has been deployed in the battle against Parkinson’s disease, a neurodegenerative disorder that is both progressive and disabling with significant impact on quality of life. This book explains the experience following from the achieved results in the REMPARK project on Parkinson’s disease management up to the launch of a new medical product to the European market, STAT-ONTM. The new medical device, STAT-ONTM is a real Holter for the motor symptoms associated to PD. It provides objective information about the severity and distribution of PD motor symptoms and their fluctuations in daily life, allowing for an unbiased and correct monitoring of the patient. This real-time remote monitoring solution gives additional information to neurologists, opening up new possibilities for more effective treatment, more accurate control in clinical trials, and for early detection of motor complications. The number of PD patients is continuously rising, adding complexity, especially in the management at the level of public health. It is an incurable disease, with a symptomatic treatment that tries to alleviate the associated symptoms through a correct adjustment of the medication. For this reason, it is also very important to be aware of changes in the manifestation of the symptoms, which may indicate the need for an adjustment or even a change in the therapy strategy. The intensive complementary use of STAT-ONTM by neurologists, health professionals and researchers, will increase the independence and quality of life of patients, improving their disease management, and contributing to a deeper understanding of the nature of the disease. A new information and communication technology (ICT) has been deployed in the battle against Parkinson’s disease, a neurodegenerative disorder that is both progressive and disabling with significant impact on quality of life. This book explains the experience following from the achieved results in the REMPARK project on Parkinson’s disease management up to the launch of a new medical product to the European market, STAT-ONTM. The new medical device, STAT-ONTM is a real Holter for the motor symptoms associated to PD. It provides objective information about the severity and distribution of PD motor symptoms and their fluctuations in daily life, allowing for an unbiased and correct monitoring of the patient. This real-time remote monitoring solution gives additional information to neurologists, opening up new possibilities for more effective treatment, more accurate control in clinical trials, and for early detection of motor complications. The number of PD patients is continuously rising, adding complexity, especially in the management at the level of public health. It is an incurable disease, with a symptomatic treatment that tries to alleviate the associated symptoms through a correct adjustment of the medication. For this reason, it is also very important to be aware of changes in the manifestation of the symptoms, which may indicate the need for an adjustment or even a change in the therapy strategy. The intensive complementary use of STAT-ONTM by neurologists, health professionals and researchers, will increase the independence and quality of life of patients, improving their disease management, and contributing to a deeper understanding of the nature of the disease. Cover 1 Half Title 2 Series 3 Title 4 Copyright 5 Contents 6 Preface 12 List of Contributors 14 List of Figures 16 List of Tables 22 List of Abbreviations 24 1 Management of Parkinson’s Disease: Challenges and Solutions 26 1.1 Introduction 27 1.2 Strategies to Manage Parkinson’s Disease at Different Stages 29 1.2.1 Patients at early stages 30 1.2.2 Moderately affected patients 31 1.2.3 Severely affected patients 33 1.3 Impact on the Quality of Life 33 1.4 State of the Art of the Current Trends in Illness Management 35 1.5 Challenges for the Best PD Management 37 1.6 Conclusion 41 References 42 2 Summary of the REMPARK Project Findings: Innovative Steps 46 2.1 Summary of the REMPARK Project: Objectives, Development, and Findings 46 2.2 Innovative Technology: Analysis of the Opportunity and Related Challenges 49 2.2.1 Analysis of the opportunity 52 2.2.2 Related challenges 56 2.3 The PARK-IT Project: Main Conclusions 57 2.3.1 The following steps 58 2.4 Conclusion 59 References 59 3 The STAT-ONTM Industrialization Pathway: From the Research Prototype to the Product 62 3.1 Introduction 62 3.2 The Requirements of the STAT-ONTM System 64 3.3 The STAT-ONTM Hardware Electronics 67 3.3.1 The main circuit 67 3.3.2 The power system 70 3.3.3 The inertial sensors 76 3.3.4 The printed circuit board (PCB) 76 3.4 The STAT-ONTM Firmware 78 3.4.1 Firmware for the Nordic nRF51822 78 3.4.2 Firmware for the STM32F415RGT6 87 3.5 Device Mechanical Design 88 3.5.1 Components selection 89 3.5.2 Enclosure industrialization 93 3.5.3 The belt 94 3.5.4 Packaging and labeling 97 3.5.5 Battery charging system 98 3.6 Certification and Characteristics 99 3.7 Conclusions 101 References 105 4 The EU Medical Device Regulatory Process: The STAT-ONTM 106 4.1 Introduction 106 4.1.1 Definition of a medical device 106 4.1.2 Directive MDD93/42 and the regulation MDR2017/745 107 4.1.3 The regulation processes 109 4.2 The Manufacturer’s License 111 4.3 The Technical Documentation 113 4.3.1 Part A: The summary 113 4.3.2 Part B: The detailed documentation 115 4.3.3 Part C: Updates/device modifications 128 4.4 Quality Management System 129 4.5 Conclusions 140 References 141 5 STAT-ONTM: The User Interface and Generated Report 142 5.1 Introduction 142 5.2 Requirements, Interface Description, and Different Modes of the Device 143 5.2.1 The physical interface (HMI) 145 5.2.2 The sensor modes 147 5.2.3 The software interface (HCI) 149 5.3 The Application (App) and Its Management 150 5.3.1 HOME: Main screen 151 5.3.2 The reports 156 5.4 Report Hints and Interpretation 170 5.4.1 Some interpretations on the weekly summary of motor state graph 170 5.4.2 Some details on the weekly FoG episodes 173 5.4.3 Some recommendations for a correct use of STAT-ONTM 173 5.5 Conclusion 174 References 174 6 STAT-ONTM: The Holter for Parkinson’s Disease Motor Symptoms. Real Use Cases in Clinical Praxis 176 6.1 Introduction 177 6.2 Early Detection of Motor Fluctuations 178 6.3 Improving Awareness of the First Motor Fluctuations 180 6.4 Complimenting a Poor Patient’s Interview about Her Motor Complications 183 6.5 Indirect Detection of Probable PD Nonmotor Fluctuations (NMF) 186 6.6 Deciphering the Patient’s Complaints using STAT-ONTM 190 6.7 Ambulatory Monitorization of a Patient with Advanced PD 196 6.8 Improvement of the Patient’s Awareness of the Advanced PD Stage and the Need for a Second-line Treatment 201 6.9 Identification of CANDIDATES to a Device-aided Therapy 204 6.10 STAT-ONTM Use for LCIG Tube Adjustment 209 6.11 Monitoring FoG and Second-line Treatment 212 6.12 Improving Motor Fluctuations with Variable Flow of Apomorphine Subcutaneous Infusion: The Role of STAT-ONTM 215 6.13 Simultaneous Recording of Motor Activity with the STAT-ONTM Device and Subthalamic Nucleus Field Potentials (PerceptTM) in Parkinson’s Disease 219 6.14 Telemedicine in Parkinson’s Disease: The Role of STAT-ONTM 223 6.15 Conclusion 226 References 226 7 New Open Scenarios for STAT-ONTM: The Medical Perspective 232 7.1 Introduction 232 7.2 Detection of the First PD Motor Fluctuations 234 7.3 Identification of Freezing of Gait and Falls 235 7.4 Detection of Dyskinesias 237 7.5 Detecting Non-motor Fluctuations 238 7.6 Selection of a Patient for a Device-aided Therapy and Monitor Response 238 7.7 Monitor the Response to a Treatment 241 7.8 Use in Clinical Trials 242 7.9 Use as a Marker of Disease Progression 243 7.10 Research and Future Scenarios with STAT-ONTM 243 7.11 Conclusion 244 References 244 8 New Open Scenarios for STAT-ONTM: The Business Perspective 252 8.1 Introduction: A General Overview 252 8.2 The Use of Technology for a Patient-Centered Care 254 8.3 Market Size and Impact 256 8.4 STAT-ONTM: The New Gold Standard 257 8.5 Conclusions 262 References 263 Index 266 About the Editors 268 Medicine A new information and communication technology (ICT) has been deployed in the battle against Parkinson's disease, a neurodegenerative disorder that is both progressive and disabling with significant impact on quality of life. This book explains the experience following from the achieved results in the REMPARK project on Parkinson's disease management up to the launch of a new medical product to the European market, STAT-ONTM.The new medical device, STAT-ONTM is a real Holter for the motor symptoms associated to PD. It provides objective information about the severity and distribution of PD motor symptoms and their fluctuations in daily life, allowing for an unbiased and correct monitoring of the patient. This real-time remote monitoring solution gives additional information to neurologists, opening up new possibilities for more effective treatment, more accurate control in clinical trials, and for early detection of motor complications.The number of PD patients is continuously rising, adding complexity, especially in the management at the level of public health. It is an incurable disease, with a symptomatic treatment that tries to alleviate the associated symptoms through a correct adjustment of the medication. For this reason, it is also very important to be aware of changes in the manifestation of the symptoms, which may indicate the need for an adjustment or even a change in the therapy strategy.The intensive complementary use of STAT-ONTM by neurologists, health professionals and researchers, will increase the independence and quality of life of patients, improving their disease management, and contributing to a deeper understanding of the nature of the disease.The Open Access version of this book, available at http://www.taylorfrancis.com, has been made available under a Creative Commons [Attribution-Non-Commercial (CC-BY-NC)] 4.0 license.