ADAPTIVE METHOD AND SYSTEM FOR A PERSONALIZED DAILY INFUSION THERAPY OF PARKINSON'S DISEASE

Abstract

A method and a system are described, for managing an infusion therapy in the Parkinson's disease, through the analysis of the motion status of patients, wherein the motion status can be in one of the following phases: OFF phase, wherein Parkinson's symptoms, such as rigidity, tremor and bradykinesia, emerge; ON phase wherein the symptoms markedly improve; DIS phase wherein involuntary movements emerge, called dyskinesias; as detectors of the symptoms the following parameters are used: voice analysis; face analysis; tremor analysis; movement analysis; levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of the patients; an algorithm being provided, which automatically modifies the infusion rate of a drug during the day, the infusion rate being computed by using the parameters as detectors.

Claims

1. A method for managing an infusion therapy for the treatment of Parkinson's disease, said method comprising determinig a motor status of a patient affected by said Parkinson's disease, wherein said motor status can be in one of the following phases: OFF phase, wherein Parkinson's symptoms, comprising one or more of rigidity, tremor and bradykinesia, emerge; ON phase wherein said symptoms markedly improve; DYS phase wherein involuntary movements emerge, called dyskinesias; wherein said method uses as detectors of said symptoms the following parameters: voice analysis; face analysis; tremor analysis; movement analysis; levodopa and metabolite levels of monoamines in the sub-cutaneous interstitial liquid of said patients; automatically modifying an infusion rate of a drug, said infusion rate being computed by using said parameters as detectors.

2. A system for managing an infusion therapy for the treatment of Parkinson's disease, comprising: an electronic bracelet, equipped with an accelerometer, a magnetometer and a gyroscope, three-axial, for collecting data continuously about tremor and movement; a photo-camera to shoot face expressions, to be actuated upon request of a patient; a recorder to record the patient voice, to be actuated upon request of the patient; a micro-dialysis pump connected to an analysing unit and to a sub-cutaneous needle, adapted to collect and analyse samples of interstitial liquid to determine the levodopa and metabolite levels of the monoamines in said sub-cutaneous interstitial liquid; a processing device, equipped with a suitable software which, using a movement stabilizing algorithm, adapted to integrate data about movement, tremor, face, voice and levodopa and metabolite levels of monoamines in said sub-cutaneous interstitial liquid, computes an infusion rate of a drug necessary to keep an ON motor status, using as feedback data about a starting therapeutic scheme; an electronic interface, connected to said processing device, adapted to modify the infusion rate of the drug with a new rate computed by said movement stabilizing algorithm.

3. The system for managing an infusion therapy for the treatment of Parkinson's disease according to claim 2, wherein said photo-camera, said recorder, said processing device and related software are integrated in a handheld computer/smartphone, so that the electronic bracelet and the analysing unit send analysis data about movement, tremor and levodopa and metabolite levels of monoamines directly to said handheld computer/smartphone.

Description

[0034] The present invention will be better described by a preferred embodiment, given by way of non-limiting example, with reference to the attached drawings, in which:

[0035] FIG. 1 shows a system for the management of infusion therapy in Parkinson's disease, according to the invention;

[0036] FIG. 2 shows a variant of the system according to the invention.

[0037] With reference to FIG. 1, the system (1) for the management of infusion therapy in Parkinson's disease includes: [0038] an electronic bracelet (2), equipped with an 10 accelerometer, a magnetometer and a triaxial gyroscope, used to continuously collect data on tremor and movement; [0039] a camera (3) for recording facial expressions, to be activated at the request of the patient; [0040] a recorder (4) for recording the voice, to be activated at the request of the patient; [0041] a micro-dialysis pump (5) connected to an analyzer unit (5a) and with a subcutaneous needle for the collection of samples of interstitial fluid to determine the levels of levodopa and monoamine metabolites in said subcutaneous interstitial fluid; [0042] a processing device (6), equipped with suitable software which, using a movement stabilization algorithm designed to integrate movement, tremor, facial, vocal data and the levels of levodopa and monoamine metabolites in said subcutaneous interstitial fluid, calculates the drug infusion rate necessary to maintain the motor state ON, using the data of the initial therapeutic scheme as feedback (100); [0043] an electronic interface (7) that modifies the drug infusion rate, with the new speed calculated by said movement stabilization algorithm.

[0044] Starting from said initial therapy (100), established on the basis of the symptoms observed, the functioning of the system (1), to modulate the therapy according to the course of the disease, is divided into the following steps.

[0045] Step 1—The electronic bracelet (2) continuously records the patient's movement (10) and tremor (11) data.

[0046] Step 2—When the patient perceives a state of OFF or marked dyskinesias (DIS), he uses the camera (3) to record facial expressions (12) and the recorder (4) to record his voice (13). At the same time, the analyzer unit (5a) detects the levels of levodopa and monoamine metabolites (14) in the interstitial fluid samples taken from the micro-dialysis pump (5) through said subcutaneous needle.

[0047] Step 3—The processing device (6) receives the combined data from the electronic bracelet (2), the camera (3), the recorder (4) and the analyzer unit (5a) connected to the micro-dialysis pump (5) of movement (10), tremor (11), facial images (12), voice (13) and levels of levodopa and monoamine metabolites (14) and, through the movement stabilization algorithm (15), determines the new drug infusion rate (101). Finally, the drug infusion rate is modified through said electronic interface (7).

[0048] According to a preferred embodiment (1a), shown in FIG. 2, the camera (3), the recorder (4), the processing device (6) and the related software are integrated in a PDA/smartphone (8), so that the electronic bracelet (2) and the analyzer unit (5a) connected to the micro-dialysis pump (5), send the analysis data of movement (10) and tremor (11) and levels of levodopa and monoamine metabolites (14) directly to the PDA/smartphone (8), which will send to the electronic interface (7) the instructions for modifying the drug infusion rate, with the new rate (101) calculated by said movement stabilization algorithm.

[0049] The drug infusion rate (101), modified in real time according to the course of the disease, will substantially maintain a motor state of ON, without motor OFF or dyskinesias.