Movement disorder monitoring and symptom quantification system and method

• US 8,845,557 B1
• Filed: 03/05/2013
• Issued: 09/30/2014
• Est. Priority Date: 03/17/2005
• Status: Active Grant

• Current Assignee: Great Lakes Neurotechnologies Inc.
• Original Assignee: Great Lakes Neurotechnologies Inc.
• Inventors: Giuffrida, Joseph P., Heldman, Dustin A.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): Danega, Renee
• Application Number:
  US13/784,939
• Time in Patent Office: 574 Days
• Field of Search: 600/595
• US Class Current: 600/595
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/1123 Discriminating type of movement, e.g. walking or running A61B5/1116, A61B5/112 take precedence
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6825 Hand
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: A61B 5/7242 using integration
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

The present invention relates to a movement disorder monitor with high sensitivity, and a method of measuring the severity of a subject'"'"'s movement disorder. The present invention additionally relates to a drug delivery system for dosing a subject in response to the increased severity of a subject'"'"'s symptoms. The present invention provides for a system and method, which can accurately and repeatably quantify symptoms of movements disorders, accurately quantifies symptoms utilizing both kinetic information and/or electromyography (EMG) data, that can be worn continuously to provide continuous information to be analyzed as needed by the clinician, that can provide analysis in real-time, that allows for home monitoring of symptoms in subject'"'"'s with these movement disorders to capture the complex fluctuation patterns of the disease over the course of days, weeks or months, that maximizes subject safety, and that provides substantially real-time remote access to data by the clinician or physician.

Claims

1. A method of quantifying severity of a subject'"'"'s movement disorder comprising the steps of:

providing a device to a subject, the device comprising at least one sensor having a signal corresponding to a subject'"'"'s external body motion associated with a movement disorder;

measuring the subject'"'"'s external body motion with the at least one sensor while the subject performs at least one movement disorder test corresponding to at least one movement disorder symptom;

transmitting a signal from the at least one sensor to a processor; and

calculating substantially in real time with the processor a symptom quantification measure based at least in part on the signal from the at least one sensor;

wherein the device has a real-time average intraclass correlation (ICC) of at least about 0.60, and the device also has a real-time average minimum detectable change (MDC) that represents a change of about 25% or less of the total scale of the particular test.

2. The method of claim 1 wherein the device is adapted to be worn on at least one of the subject'"'"'s extremities, such as arm, wrist, hand, finger, legs, feet, toes or head.

3. The method of claim 1 wherein the measured external body motion and at least one movement disorder test correspond to a movement disorder symptom of dyskinesia.

4. The method of claim 1, wherein the at least one movement disorder test corresponds to motor side effects of medication.

5. The method of claim 1, wherein the at least one movement disorder test is used to define a disease state, the disease states corresponding to the effectiveness of medication.

6. The method of claim 1, wherein the at least one movement disorder test corresponds to the movement disorder symptom grouping related to the subject'"'"'s motor examination associated with one or more movement, activity or motion of Unified Parkinson'"'"'s Disease Rating Scale section III (UPDRS-III).

7. A method of quantifying severity of a subject'"'"'s movement disorder comprising the steps of:

providing a device to a subject, the device comprising at least one sensor having a signal corresponding to a subject'"'"'s external body motion associated with a movement disorder,

measuring the subject'"'"'s external body motion with the at least one sensor while the subject performs at least one movement disorder test corresponding to at least one movement disorder symptom;

transmitting a signal from the at least one sensor to a processor; and

calculating substantially in real time with the processor a symptom quantification measure based at least in part on the signal from the at least one sensor;

wherein the device has a real-time average minimum detectable change (MDC) that represents a change of about 25% or less of the total scale of the particular test.

8. The method of claim 7 wherein the device is adapted to be worn on at least one of the subject'"'"'s extremities, such as arm, wrist, hand, finger, legs, feet, toes or head.

9. The method of claim 7 wherein the device also has a real-time average intraclass correlation (ICC) of at least about 0.60.

10. The method of claim 7 wherein the measured external body motion and at least one movement disorder test correspond to a movement disorder symptom of dyskinesia.

11. The method of claim 7, wherein the at least one movement disorder test(s) correspond to motor side effects of medication.

12. The method of claim 7, wherein the at least one movement disorder test is used to define a disease state, the disease states corresponding to the effectiveness of medication.

13. The method of claim 7 wherein the at least one movement disorder test(s) correspond to the movement disorder symptom grouping related to the subject'"'"'s motor examination associated with one or more activity, movement, or motion of Unified Parkinson'"'"'s Disease Rating Scale section III (UPDRS-III).

14. A portable device for quantifying severity of a subject'"'"'s movement disorder comprising:

at least one sensor having a signal for measuring a subject'"'"'s external body motion or physiological signal associated with a movement disorder, and

at least one processor for receiving the sensor signal and calculating the severity of the subject'"'"'s movement disorder symptom(s) in real time,

wherein the device has a real-time average intraclass correlation (ICC) of at least about 0.60.

15. The device of claim 14 wherein the device is adapted to be worn on at least one of the subject'"'"'s extremities, such as arm, wrist, hand, finger, legs, feet, toes or head.

16. The device of claim 14, wherein the movement disorder symptom(s) whose severity is calculated correspond to motor side effects of medication.

17. The device of claim 14, wherein the calculated movement disorder symptom(s) severity defines a disease state, the disease states corresponding to the effectiveness of medication.

18. The device of claim 14, wherein the movement disorder symptom(s) whose severity is calculated correspond to the movement disorder symptom grouping related to the subject'"'"'s motor examination associated with one or more activity, movement, or motion of Unified Parkinson'"'"'s Disease Rating Scale section III (UPDRS-III).

19. The device of claim 14, wherein the device measures the subject'"'"'s movement disorder symptom severity while the subject performs at least two first and second movement disorder tests, at least one of each of the first and second tests corresponding to the movement disorder symptom grouping related to the subject'"'"'s motor examination associated with one or more activity, movement, or motion of Unified Parkinson'"'"'s Disease Rating Scale section III (UPDRS-III), and at least one of each of the first and second tests corresponding to motor side effects such as dyskinesias.