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Title:
METHOD AND GLOVE/DEVICE FOR THE DETERMINATION AND IMPROVED EVALUATION OF THE MOTOR SYMPTOMS OF A DISEASE
Document Type and Number:
WIPO Patent Application WO/2017/221037
Kind Code:
A1
Abstract:
This invention concerns a device/glove (1) which constitutes a precise measuring instrument of an individual's motor status, as well as the device's technical equipment and support method during the measurement and processing of results for determining motor status. According to this invention, the glove/device (1) offers innovative potential for monitoring and offering individualized treatment to patients, as well as for conducting extensive group studies. According to this invention, the glove/device (1) is particularly suitable for supporting patients suffering from Parkinson's disease.

Inventors:
TZALLAS ALEXANDROS (GR)
TSIPOURAS MARKOS (GR)
SMANIS IOANNIS (GR)
KATERTSIDIS NIKOLAOS (GR)
GIANNAKEAS NIKOLAOS (GR)
Application Number:
PCT/GR2017/000034
Publication Date:
December 28, 2017
Filing Date:
June 21, 2017
Export Citation:
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Assignee:
TZALLAS ALEXANDROS (GR)
TSIPOURAS MARKOS (GR)
SMANIS IOANNIS (GR)
KATERTSIDIS NIKOLAOS (GR)
GIANNAKEAS NIKOLAOS (GR)
International Classes:
A61B5/04; A61B5/00; A61B5/11
Foreign References:
US20120144554A12012-06-14
US20140257047A12014-09-11
US20110224530A12011-09-15
CN104127187A2014-11-05
US20160070347A12016-03-10
Other References:
None
Download PDF:
Claims:
CLAIMS

1. The glove/device (1) consisting of fabric and interconnected electronic parts, with triaxial accelerometer (1.6) is described by the fact that a. each finger has a flex sensor (1.1.1) for recording the position/flexion of each finger b. the fingertips and the palm, on the interior surface of the glove, have sensors (1.2.1 , 3) made of conductive material for recording contact between them.

2. According to claim 1, the glove/device is described by the fact that it has equipment that may be connected to a computer.

3. According to claim 1, the glove/device is described by the fact that it has a memory card slot (1.7).

4. The method for determining the motor status of an individual that presents motor symptoms consists of: a. collecting a series of data/measurements from a glove/device according to claim 1 for a period of 3-10 minutes, b. storing the measurements in a memory card (1.7), c. processing the data in order to objectively evaluate the patient's motor status within a given time interval.

5. The claim 4 method, whereby data/measurements are collected, is in compliance with an internationally recognized protocol for examining a patient suffering from Parkinson's disease.

6. The claim 4 method, whereby data/measurements are collected, is in compliance with part III of the Unified Parkinson's Disease Rating Scale (UPDRS) of a patient suffering from Parkinson's disease.

7. The claim 4 method, whereby data/measurements are collected, is in compliance with an internationally recognized protocol for conducting clinical studies.

8. Use of the glove/device according to claims 1-3 for the treatment of motor disorders in an individual requiring treatment.

9. Use of the method for determining the motor status of an individual according to claims 4-7 in the study and the treatment of motor disorders in individuals requiring treatment.

Description:
Method and glove/device for the determination and improved evaluation of the motor symptoms of a disease

DESCRIPTION

Technical scope This invention involves a method and a glove/device used to determine the motor status of an individual suffering from a disorder or disease which presents motor symptoms.

Background of the invention

There are many factors that could result in the manifestation of motor symptoms in individuals, such as diseases, pharmaceutical treatments, injuries and others. These motor symptoms include dyskinesia, during which an individual is in a hyperkinetic state, and bradykinesia, during which the individual is in a hypokinetic state.

Bradykinesia is a primary sign of disease in patients suffering from Parkinson's disease, for example. These patients are treated with levodopa, which induces dyskinesia for some time following drug administration. After administration, levodopa has a half-life of about 90 minutes.

As Parkinson's disease progresses, the half-life of levodopa is reduced, resulting in the reduction of the area of the effective dose. However, this renders the choice and control of the dosing regimen an extremely difficult and complex matter. It is usually addressed by increasing the dosing frequency, on many occasions up to ten times a day, in an effort to control the symptoms and to allow the patient to have a relatively good quality of life.

This means that patients suffering from Parkinson's disease experience periods of bradykinesia, periods of dyskinesia and periods of relatively normal motor function. This occurs many times in a day and throughout the action of a single dose of levodopa. Even if a satisfactory dosing regimen is selected at a specific time, given the progressive nature of Parkinson's disease, this means that the treating neurologist needs to systematically monitor a patient's symptoms in order to systematically control the patient's relevant dosing regimen. This is extremely challenging and in practice it results in the treating physician prescribing a larger dose, which increases episodes of dyskinesia, or an inadeguate dose, which does not prevent episodes of bradykinesia. A conventional treatment regimen is based on the objective discretion of the treating physician. However, they do not have an objective measurement to determine whether a change in dosing is effective in improving the symptoms of the disease. Moreover, clinical observation is conducted for a short period of time, during a patient's physical exam, usually for 10 to 20 minutes once every two months or even every six months. However, the fluctuations in an individual's motor status from one day to the next and from one hour to the next render the determination of an individual's motor status an extremely difficult and complex matter. Physicians are often forced to rely on the patient's description and/or written diaries to gain an understanding of the patient's ongoing motor status between clinical appointments (and the corresponding objective exam). In practice, however, patients are not able to objectively score their state, and the motor episodes themselves make it difficult for a patient to objectively and precisely record the nature and timing of motor episodes.

Monitoring the progress of Parkinson's disease in an individual and knowing when to make the change in their treatment presents a significant problem in verifying/recognizing the stage when conventional treatments, such as levodopa, can no longer control the symptoms and alternative treatments, such as advanced pharmaceutical forms or robot-assisted treatments, are needed. For many patients, especially the elderly, the window during which alternative treatments must be selected is small and possibly ineffective if there is a delay in their implementation. This means that the untimely (possibly delayed) implementation of an alternative treatment may potentially reduce the benefit that would have been derived from the treatment. These reasons demonstrate the imperative need for inventing a tool and a method which will determine and provide a precise evaluation of an individual's motor symptoms.

This invention addresses the current state-of-the-art problems described herein because it provides a device/glove (tool) and a method which is able to determine and provide a precise evaluation of an individual's motor symptoms.

Aided by this invention, the suitable treatment regimen is initially selected and subsequently, during the course of a disease or rehabilitation (e.g. after injury or stroke), the treatment regimen can be continuously adapted to the patient's current state, which is monitored with objective precision by way of this invention.

Brief description of the designs

The attached designs aid in the description of the device, where:

Figure 1 is a circuit diagram of the glove's electrical components (1) which include: the flex sensors (1.1.1) with their corresponding anterior extremity (1.1.2), the fingertip sensors (1.2.1) (conductive fabric) with the driver circuit (1.2.2) and a digital I/O circuit (1.2.3), a micro-controller with analog-to- digital conversion (ADC) (1.3), led lights (1.4), a Bluetooth element (1.5), an accelerometer (1.6), a memory card reader (1.7), and a clock ( .8) Figure 2 depicts the interior view of the glove, as per the invention, which consists of: the glove (1), the finger sensors (1.1.1) and the conductive surface of the palm (3)

Figure 3 depicts the exterior view of the glove in Figure 2, which consists of: the glove (1), the conductive surfaces of the fingertips (2) and the conductive surface of the palm (3)

Description of invention This invention involves a device/glove (1), which constitutes a precise measuring instrument of an individual's motor status, as well as the device's technical equipment and support method during measurements and processing of results. According to this invention, the glove (1) is made of a combination of fabrics with electronic components.

This glove (1) has sensors (1.1.1 , 1.2.1) on each finger, an accelerometer (1.6), which is located on the upper part of the palm, surface areas (3), which are good electrical conductors, conductive threads, and circuits sewn in the interior surface of the glove fabric. It also has a coil sewn under a protective plastic cover, internally connected to the system's main circuit, which is covered by a case. This glove (1) has special sensors that monitor the most significant movements made by the hand and fingers. The five finger sensors (1.1.1) can measure the position of the fingers by adjusting their resistance. Moreover, it also has a triaxial accelerometer (1.6) on the upper part of the palm, which measures the position of the wrist.

Conductive materials are sewn along the entire lower part of the palm. This ensures that fingertips are able to interact with any capacitive touchscreen. The coil is responsible for the glove's (1) wireless charging. There are also four very small natural magnets for load alignment. All the sensors and power supply are connected via fine wires and electrically conductive threads to a box which contains all the necessary led light (1.4) switches, circuits and memory card slot (1.7), for controlling all the functions.

There two groups of led lights on the upper section, and a relay controller and corresponding led lights on the front. The rear of the element contains an attached storage and error detection interface.

In terms of monitoring patients with motor problems, current practice primarily depends on the patient visiting the treating physician. During these visits, the physician attempts to determine and evaluate the patient's status and the efficiency -df the UVi ll ¾¾¾¾W¾nt¾y exait iiiig iu ' ta¾Hg ϊϋ uie paueiu, and by reviewing the patient's daily diary. This procedure is based on objective criteria, since the patient's status during the physical exam may not be indicative of their everyday status at home, while the data concerning the patient's status at home are greatly subjective because they either come from the patients themselves (via an intervie or a diary kept by the patient) or from

It is for this reason that every strategy/method that records the motor symptoms - and, through their analysis, objectively evaluates the patient's

- offers

significant and objective clinical information and permits early and timely therapeutic interventions by the physician. The glove/device (1) constitutes a tool/instrument for applying such a strategy/method, since it aims at constantly monitoring and objectively evaluating the patient's motor status and optimally adjusting their pharmaceutical treatment, being equipped with: a series of sensors (1.1.1) above the fingers for the purpose of recording the finger movements; a conductive fabric on the fingertips and the interior of the palm; and a triaxial accelerometer (1.6) on the upper part of the palm. The main purpose of this glove/device is for the patient to be able to wear it without medical supervision, and to objectively record and evaluate their motor status. When the patients wear the glove (1) at a predetermined time during the day (e.g. before or after medication, depending of the patient's symptoms, in relation to meals, etc.), the physician is able to receive significant information regarding the patient's bradykinesia and rest tremors, which can be used to optimize the patient's treatment regimen. This results in improving the patient's qjjality of life, since problems are detected and addressed at their onset, while the patient is offered individualized treatment based on the symptomatic expression of the disease and the side effects due to the treatment regimen. In the case of treating physicians, it is the first time they are able to perform an objective evaluation of the patient's motor status for the intervals between visits, thus improving the quality of the services they provide. The glove/device receives a series of data (numeric values from the sensors at regular intervals / time series), which are then processed using a new analysis method, aimed at the automated and objective evaluation of the patient's motor status. The objective determination method of a patient's motor status based on this invention includes three main analysis steps: a. preprocessing the time series using known digital signal processing techniques aimed at improving their quality and removing undesirable features, b. processing the time series using known digital signal processing techniques aimed at extracting features that are associated with the patient's motor status, c. analyzing the extracted features using known statistical methods and intelligent techniques aimed at the automated evaluation and measurement of the patient's motor status. iri the exaffipfe 6f£ patient suffering from H¾rkinsonis disease: according to step b: the time series are processed using digital signal processing techniques aimed at extracting features that are associated with the patient's motor status. The extracted features quantify movement traits. Typicai examples include:

• Movement frequency (e.g. frequency of finger movements).

• Movement width (e.g. maximum distance between index finger and thumb- on repetitive finger movements).

• Hesitation in movement (e.g. delay in movement onset).

• Pauses in ongoing movement. according to step c: the extracted features are analyzed using known statistical methods and intelligent techniques aimed at the automated evaluation and measurement of the patient's motor status. Various cognitive and data-driven techniques are used to analyze the features. Typical examples include:

• The cognitive model based on the Unified Parkinson's Disease Rating Scale (UPDRS). This model constitutes the standard quantification of ίίίϋ litch ( J UHS stiM a grading p m OYI trie CM H( (&. H S model is based on the processing of signals that are recorded by the glove, aimed at quantifying the rating scale qualitative data, such as slowing down of movement, change in movement width, pauses in ongoing movement and hesitation at the onset of movement.

• Statistical model based on the maximum likelihood estimation in relation to the distribution of parameter values for every scale value, which is calculated by an initial data set.

• Inteiiiigent techniques arising from learning the structure of a known model (e.g. decision trees, random forests, neural networks, support vector machines, etc.), which are applied based on an initial data set. Moreover, fuzzy logic is incorporated into the model aiming at the quantification of vague definitions, such as "mild", "moderate", "severe", "frequent". This is implemented by using fuzzy correlation functions, a fuzzy logic machine and an output defuzzification technique.

The various techniques for analyzing both the cognitive and data- driven features are well known and are not further described herein.

With regard to the current invention of the glove/device, given the simple, automated and objective examination of the patient's motor status, it is particularly suitable for extensive clinical studies, pursuant to respective internationally recognized protocols. At the same time, it offers new potentials, which may lead to the creation of new, more efficient clinical or non-clinical studies.

If is clear that an expert in the field can modify or combine the main traits of the glove/device and the objective determination method of an individual's motor status in a different manner which is not cfescribed herein, keeping within the protected scope of this invention, as outlined in the following claims.