Devices for remote monitoring of Parkinson's disease

Parkinson's disease

2.1 Parkinson's disease is a condition that affects the brain, resulting in a progressive loss of coordination and movement problems. It is caused by a loss of the cells in the brain that are responsible for producing dopamine, which helps to control and coordinate body movements. People with Parkinson's disease experience a range of motor symptoms, which can fluctuate in severity during the day and between days. Motor symptoms may include dyskinesia (involuntary movement), bradykinesia (slowness) and tremor; non-motor symptoms include sleep disturbances. Starting or adjusting treatment helps to control symptoms. However, these treatments can themselves cause motor-related side effects. An important consideration in decisions about treatment is the need to balance the benefits of treatment with the potential side effects.

Current care pathway

2.2 NICE's guideline on Parkinson's disease recommends that people diagnosed with Parkinson's disease are seen every 6 to 12 months to review their diagnosis. More frequent follow ups may be needed to optimise medication dosage, or for people who need more advanced treatments. Current practice for monitoring motor symptoms includes using validated questionnaires, history taking and clinical observation. It can be difficult to assess the symptoms of some people with Parkinson's disease because they can have difficulty communicating, remembering or recording their symptoms. Examination at a single point in time, for example at a clinical appointment, may over or underestimate symptom severity or incidence, given that motor fluctuations can vary over time.

Potential value of technologies

2.3 Devices that can monitor and record symptoms of Parkinson's disease could identify people who could benefit from changes to their care. By objectively measuring these symptoms over several days, the technologies may more accurately estimate a person's symptoms and help to inform medication decisions. At scoping, clinical experts highlighted that functionality to measure dyskinesia and bradykinesia was particularly important for this.

2.4 Better-informed treatment decisions could lead to improved quality of life. Improved motor symptoms could also reduce falls and hip fractures. The technologies could also help improve communication between people with Parkinson's disease and clinicians when discussing symptoms and potential changes to care.

2.5 The technologies may also allow more remote monitoring of Parkinson's disease. This could help to alleviate the stress and anxiety of attending clinical appointments. Objective monitoring of symptoms could also reduce the length and number of clinical appointments, thereby freeing up NHS resources.

Kinesia 360

2.7 The Kinesia 360 motor assessment system (Great Lakes NeuroTechnologies) monitors movement to quantify motor symptoms and assess activity. The system comprises sensors worn on the wrist and ankle, a tablet, and a charge pad. Kinesia 360 measures various aspects of bradykinesia, dyskinesia and tremor. It has a 16-hour battery life, so typically someone will wear the sensors during the day and recharge the device overnight.

2.8 Algorithms are used to automatically calculate severity scores, which healthcare professionals can view through web-based reports. Data is automatically downloaded from the device and uploaded to the Kinesia Web Portal during recharging. The mobile application also includes electronic diaries for capturing patient-reported outcomes and customisable medication diaries.

2.9 Healthcare staff can be trained in Kinesia 360 in about 30 minutes. The technology costs £224 for a monthly device subscription.

KinesiaU

2.10 The KinesiaU motor assessment system (Great Lakes NeuroTechnologies) comprises a smartwatch and smartphone application. Symptoms can be measured through continuous recording or through specific active tasks (which can be done while being monitored continuously). The system rates the severity of tremor, slowness and dyskinesia symptoms into good, mild, moderate and severe categories (averaged for the selected time range). The product is to be used only under the direction of a qualified clinician.

2.11 Reports can be produced throughout the day and over the course of days, weeks and months in response to therapy and activities. Users can view or share reports in real time via the smartphone application. Healthcare professionals can access reports remotely through the KinesiaU provider portal. The mobile application also includes customisable medication and exercise diaries, which can be added to the report.

2.12 Healthcare staff can be trained in KinesiaU in about 30 minutes. The KinesiaU costs £64 per patient for a monthly subscription.

PDMonitor

2.13 The PDMonitor system (PD Neurotechnology) consists of a SmartBox, 5 sensors and a PDMonitor mobile application. The sensors are worn on both wrists, both ankles and one is worn on the waist, and acquire movement data for assessing motor symptoms. The system measures activity, posture, bradykinesia, freezing of gait, gait disturbances, wrist tremor, leg tremor, dyskinesia and 'on' periods (when the Parkinson's disease responds to treatment and motor performance is normal) and 'off' periods (when medication becomes less effective). It also provides a summary of measured daily activity. The duration and frequency of use is decided by the physician.

2.14 The PDMonitor SmartBox is a docking station for charging the monitoring devices, and for collecting, storing and processing data and uploading them to the PD Neurotechnology storage service. Healthcare professionals can access reports through the mobile application, which also includes medication, diet and self-reported symptom diaries.

2.15 Training is offered by the company to healthcare professionals, and there is a user manual for the physician tool. The device is purchased outright for £12,000.

Personal KinetiGraph (PKG)

2.16 The PKG Movement Recording System (Global Kinetics) is a wrist-worn PKG watch that continuously measures movement over a 6-day period. The PKG measures bradykinesia, dyskinesia, tremors, motor fluctuations, immobility and when the watch is not being worn. It is also intended to be used to monitor activity associated with movement during sleep.

2.17 The PKG watch is returned by the user to the company (using a prepaid addressed envelope), which extracts the data and generates reports for users and healthcare professionals to view online. As well as providing the raw data, algorithm-generated movement scores are provided for the whole 6‑day period. The report includes summary graphs showing measurements over time and a summary of results, along with a suggested target range for interpretation. It has medication reminders and users can record when they have taken their medication.

2.18 The company provides education and training to healthcare professionals. It advises that healthcare professionals should complete an average of 15 to 20 PKGs to be proficient, supported by an eLearning module, which takes approximately 1 to 2 hours. The device costs £225 per use per patient.

STAT-ON

2.19 The STAT-ON system consists of a monitoring device, a base charger, a belt with a waist-worn inertia recorder attached, and a mobile application. The system must be configured by a healthcare professional through the mobile application. The smartphone application connects to the STAT-ON device via Bluetooth. Results are stored in its internal memory. The device measures dyskinesia, 'on' and 'off' periods, gait parameters (including bradykinesia and freezing of gait), falls, energy expenditure and posture. It does not measure tremor. The user should wear the device for a minimum of 5 days (ideally for 7 days), totalling a minimum of 24 hours over the 5 days, to collect enough data. After this, a report can be generated.

2.20 The device collects data and uses algorithms to process it. Detailed data analyses are available in the report, as well as summaries of activity and prevalence of symptoms during the monitored period. Health professionals can download the report to their phone using the mobile application. The application also has medication reminders and people can record when they have taken their medication.

2.21 Training sessions last 1.5 hours. Quick guides, videos and graphical training documents are provided for healthcare professionals to understand how the system is configured and how to interpret the report. The device costs £1,600 for an annual device subscription.

The comparator

2.22 The comparator is clinical judgement of motor and non-motor symptoms based on information including clinical history and patient diaries, which may include rating scale tools and activity trackers. The Unified Parkinson's Disease Rating Scale (UPDRS) and the Hoehn and Yahr scale can be used to describe and assess symptoms related to Parkinson's disease.