Front Cover
Half Title Page
River Publishers Series in Biomedical Engineering
Title Page
Copyright Page
Contents
Preface
List of Contributors
List of Figures
List of Tables
List of Abbreviations
1 Management of Parkinson’s Disease: Challenges and Solutions
	1.1 Introduction
	1.2 Strategies to Manage Parkinson’s Disease at Different Stages
		1.2.1 Patients at early stages
		1.2.2 Moderately affected patients
		1.2.3 Severely affected patients
	1.3 Impact on the Quality of Life
	1.4 State of the Art of the Current Trends in Illness Management
	1.5 Challenges for the Best PD Management
	1.6 Conclusion
	References
2 Summary of the REMPARK Project Findings: Innovative Steps
	2.1 Summary of the REMPARK Project: Objectives, Development, and Findings
	2.2 Innovative Technology: Analysis of the Opportunity and Related Challenges
		2.2.1 Analysis of the opportunity
		2.2.2 Related challenges
	2.3 The PARK-IT Project: Main Conclusions
		2.3.1 The following steps
	2.4 Conclusion
	References
3 The STAT-ON Industrialization Pathway: From the Research Prototype to the Product
	3.1 Introduction
	3.2 The Requirements of the STAT-ON System
	3.3 The STAT-ON Hardware Electronics
		3.3.1 The main circuit
		3.3.2 The power system
		3.3.3 The inertial sensors
		3.3.4 The printed circuit board (PCB)
	3.4 The STAT-ON Firmware
		3.4.1 Firmware for the Nordic nRF51822
		3.4.2 Firmware for the STM32F415RGT6
	3.5 Device Mechanical Design
		3.5.1 Components selection
		3.5.2 Enclosure industrialization
		3.5.3 The belt
		3.5.4 Packaging and labeling
		3.5.5 Battery charging system
	3.6 Certification and Characteristics
	3.7 Conclusions
	References
4 The EU Medical Device Regulatory Process: The STAT-ON
	4.1 Introduction
		4.1.1 Definition of a medical device
		4.1.2 Directive MDD93/42 and the regulation MDR2017/745
		4.1.3 The regulation processes
	4.2 The Manufacturer’s License
	4.3 The Technical Documentation
		4.3.1 Part A: The summary
		4.3.2 Part B: The detailed documentation
		4.3.3 Part C: Updates/device modifications
	4.4 Quality Management System
	4.5 Conclusions
	References
5 STAT-ON: The User Interface and Generated Report
	5.1 Introduction
	5.2 Requirements, Interface Description, and Different Modes of the Device
		5.2.1 The physical interface (HMI)
		5.2.2 The sensor modes
		5.2.3 The software interface (HCI)
	5.3 The Application (App) and Its Management
		5.3.1 HOME: Main screen
		5.3.2 The reports
	5.4 Report Hints and Interpretation
		5.4.1 Some interpretations on the weekly summary of motor state graph
		5.4.2 Some details on the weekly FoG episodes
		5.4.3 Some recommendations for a correct use of STAT-ON
	5.5 Conclusion
	References
6 STAT-ON: The Holter for Parkinson’s Disease Motor Symptoms. Real Use Cases in Clinical Praxis
	6.1 Introduction
	6.2 Early Detection of Motor Fluctuations
	6.3 Improving Awareness of the First Motor Fluctuations
	6.4 Complimenting a Poor Patient’s Interview about Her Motor Complications
	6.5 Indirect Detection of Probable PD Nonmotor Fluctuations (NMF)
	6.6 Deciphering the Patient’s Complaints using STAT-ON
	6.7 Ambulatory Monitorization of a Patient with Advanced PD
	6.8 Improvement of the Patient’s Awareness of the Advanced PD Stage and the Need for a Second-line
	6.9 Identification of CANDIDATES to a Device-aided Therapy
	6.10 STAT-ON Use for LCIG Tube Adjustment
	6.11 Monitoring FoG and Second-line Treatment
	6.12 Improving Motor Fluctuations with Variable Flow of Apomorphine Subcutaneous Infusion: The Rol
	6.13 Simultaneous Recording of Motor Activity with the STAT-ON Device and Subthalamic Nucleus Fiel
	6.14 Telemedicine in Parkinson’s Disease: The Role of STAT-ON
	6.15 Conclusion
	References
7 New Open Scenarios for STAT-ON: The Medical Perspective
	7.1 Introduction
	7.2 Detection of the First PD Motor Fluctuations
	7.3 Identification of Freezing of Gait and Falls
	7.4 Detection of Dyskinesias
	7.5 Detecting Non-motor Fluctuations
	7.6 Selection of a Patient for a Device-aided Therapy and Monitor Response
	7.7 Monitor the Response to a Treatment
	7.8 Use in Clinical Trials
	7.9 Use as a Marker of Disease Progression
	7.10 Research and Future Scenarios with STAT-ON
	7.11 Conclusion
	References
8 New Open Scenarios for STAT-ON: The Business Perspective
	8.1 Introduction: A General Overview
	8.2 The Use of Technology for a Patient-Centered Care
	8.3 Market Size and Impact
	8.4 STAT-ON: The New Gold Standard
	8.5 Conclusions
	References
Index
About the Editors
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