Movement disorder therapy system, devices and methods, and methods of remotely tuning

• US 9,289,603 B1
• Filed: 09/10/2013
• Issued: 03/22/2016
• Est. Priority Date: 09/10/2012
• Status: Active Grant

• Current Assignee: Great Lakes Neurotechnologies Inc.
• Original Assignee: Great Lakes Neurotechnologies Inc.
• Inventors: Giuffrida, Joseph P, Heldman, Dustin A, Mera, Thomas O
• Primary Examiner(s): Sorey, Robert
• Application Number:
  US14/022,323
• Time in Patent Office: 924 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0214 of power generation or supply
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• 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 5/1118 Determining activity level
• CPC Class Codes: A61B 5/1124 Determining motor skills
• CPC Class Codes: A61B 5/1125 Grasping motions of hands
• 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 5/6825 Hand
• CPC Class Codes: A61B 5/6887 mounted on external non-worn devices, e.g. non-medical devices
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36067 : Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36082 : Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36128 : Control systems
• CPC Class Codes: A61N 1/36132 : using patient feedback
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/37235 : Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/60 : for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

The present invention relates to methods for remotely tuning treatment parameters in movement disorder therapy systems where the subject and clinician are located remotely from each other. The present invention still further provides methods of quantifying movement disorders for the treatment of patients who exhibit symptoms of such movement disorders including, but not limited to, Parkinson'"'"'s disease and Parkinsonism, Dystonia, Chorea, and Huntington'"'"'s disease, Ataxia, Tremor and Essential Tremor, Tourette syndrome, stroke, and the like. The present invention yet further relates to methods of remotely tuning a therapy device using objective quantified movement disorder symptom data to determine the therapy setting or parameters to be transmitted and provided to the subject via his or her therapy device. The present invention also provides treatment and tuning remotely, allowing for home monitoring of subjects.

Claims

1. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject with an implanted deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of electrode polarity, frequency, amplitude, current, pulse width/wavelength, waveform type, and contact configuration;

instructing, via a device with a processor in communication with the movement disorder diagnostic device, or by the clinician, physician or technician, the subject to perform at least one movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy,

wherein the movement disorder test corresponds to a set of first level DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to the device with a processor;

extracting, by the device with a processor, at least one kinematic feature from the measured movement data;

processing, by the device with a processor, the at least one kinematic feature with an algorithm to obtain at least one score;

displaying, on a display, the subject'"'"'s measured movement data and the at least one score to a clinician, physician or technician;

determining, by the clinician, physician or technician, based at least in part on the subject'"'"'s measured movement data and the at least one score, a set of second level DBS parameters to alter the subject'"'"'s performance on the at least one movement disorder test;

entering, automatically by the device with a processor or manually by the clinician, physician or technician, the second level DBS parameters into a programmer device in communication with the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level DBS parameters; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the second level DBS parameters to provide altered DBS therapy to the subject.

2. The method of claim 1, wherein the second level of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of at least one side effect.

3. The method of claim 1, wherein the algorithm comprises one or more of a simple or multiple linear regression, an artificial neural network, a Bayesian network, or a genetic algorithm;

and

wherein the at least one kinematic feature is a feature selected from the list comprising peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, wavelet parameters, and the covariance or standard deviation over time of any of peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, or wavelet parameters.

4. The method of claim 1, further comprising the step of uploading the second level DBS parameters and the at least one score to a remote database for storage and later access by a clinician, physician or technician after or at substantially the same time as the step of entering the second level DBS parameters into the programmer device in communication with the subject'"'"'s DBS device.

5. The method of claim 1, wherein the data corresponding to the subject'"'"'s measured movement data and the at least one score is displayed visually for review by the clinician, physician or technician in the form of a tuning map comprising a two-dimensional representation of a three-dimensional graph relating motor symptom severity and/or therapeutic side-effect severity to DBS parameter settings.

6. The method of claim 5, wherein the data and/or second level DBS parameters are reviewed and approved by a clinician, physician or technician prior to entry of the second level DBS parameters into the programmer device in communication with the subject'"'"'s therapy device.

7. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject with an implanted deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of electrode polarity, frequency, amplitude, current, pulse width/wavelength, waveform type, and contact configuration;

instructing, via a device with a processor in communication with the movement disorder diagnostic device, or by the clinician, physician or technician, the subject to perform at least one movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy,

wherein the movement disorder test corresponds to a set of first level DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to the device with a processor;

extracting, by the device with a processor, at least one kinematic feature from the measured movement data;

processing, by the device with a processor, the at least one kinematic feature with an algorithm to obtain at least one score;

displaying, on a display, the subject'"'"'s measured movement data and the at least one score to a clinician, physician or technician;

determining, by the clinician, physician or technician, based at least in part on the subject'"'"'s measured movement data and the at least one score, at least two optional groups of DBS parameters to alter the subject'"'"'s performance on the at least one movement disorder test, each optional group of DBS parameters corresponding to a different desired outcome or constraint;

selecting, by the clinician, physician or technician, one of the at least two optional groups of DBS parameters;

entering, automatically by the device with a processor or manually by the clinician, physician or technician, the selected optional group of DBS parameters into a programmer device in communication with the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the selected optional group of DBS parameters; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the selected optional group of DBS parameters to provide altered DBS therapy to the subject.

8. The method of claim 7, wherein at least one of the at least two optional groups of DBS parameters corresponds to a motor symptom, and at least one of the at least two optional groups of DBS parameters corresponds to a side effect, and the selected group of DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of the selected motor symptom or side effect.

9. The method of claim 7, wherein the algorithm comprises one or more of a simple or multiple linear regression, an artificial neural network, a Bayesian network, or a genetic algorithm;

and

wherein the at least one kinematic feature is a feature selected from the list comprising peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, wavelet parameters, and the covariance or standard deviation over time of any of peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, or wavelet parameters.

10. The method of claim 7, further comprising the step of selecting, by the subject, a different optional group of DBS parameters based at least in part on an activity the subject wishes to perform or a symptom or side effect that is occurring.

11. The method of claim 7, wherein the subject'"'"'s measured movement data, the at least one score, and/or the selected optional group of DBS parameters are displayed visually for review by the clinician, physician or technician, and the displayed measured movement data, the at least one score, and/or the selected optional group of DBS parameters are reviewed and approved by a clinician, physician or technician prior to entry of the selected optional group of DBS parameters into the programmer device in communication with the subject'"'"'s therapy device.

12. A method of tuning a movement disorder therapy system comprising steps of:

providing a movement disorder diagnostic device to a subject with an implanted deep brain stimulation (DBS) device operable according to adjustable DBS parameters,

wherein the movement disorder diagnostic device comprises at least one physiological or movement sensor capable of generating a signal, and the DBS parameters include one or more of electrode polarity, frequency, amplitude, current, pulse width/wavelength, waveform type, and contact configuration;

instructing, via a device with a processor in communication with the movement disorder diagnostic device, or by the clinician, physician or technician, the subject to perform at least one movement disorder test while the subject is undergoing DBS therapy or is under the effects of DBS therapy,

wherein the movement disorder test corresponds to a set of first level DBS parameters of the DBS therapy;

measuring, by the movement disorder diagnostic device, symptomatic movement of the subject to obtain movement data based at least in part on the generated signal from the at least one physiological or movement sensor during the at least one movement disorder test;

transmitting, by the movement disorder diagnostic device, the measured movement data to the device with a processor;

extracting, by the device with a processor, at least one kinematic feature from the measured movement data;

processing, by the device with a processor, the at least one kinematic feature with an algorithm to obtain at least one score;

displaying, on a display, the subject'"'"'s measured movement data and the at least one score to a clinician, physician or technician;

determining, by the clinician, physician or technician, based at least in part on the subject'"'"'s measured movement data and the at least one score, a set of second level DBS parameters to alter the subject'"'"'s performance on the at least one movement disorder test;

automatically entering, by the device with a processor, the second level DBS parameters into a programmer device in communication with the subject'"'"'s DBS device such that the subject'"'"'s DBS device operates under the second level DBS parameters; and

supplying, by the DBS device, a stimulation current to the subject'"'"'s brain under the second level of DBS parameters to provide altered DBS therapy to the subject.

13. The method of claim 12, wherein the second level DBS parameters corresponds to a quantifiable decrease in the severity and/or occurrence of at least one side effect.

14. The method of claim 12, wherein algorithm comprises one or more of a simple or multiple linear regression, an artificial neural network, a Bayesian network, or a genetic algorithm;

and

wherein the at least one kinematic feature is a feature selected from the list comprising peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, wavelet parameters, and the covariance or standard deviation over time of any of peak power angular velocity, peak power angle, RMS angular velocity, frequency, maximum amplitude, maximum peak-to-peak amplitude, mean angular velocity, or wavelet parameters.

15. The method of claim 12, wherein the data corresponding to the subject'"'"'s measured movement data and the at least one score is displayed visually for review by the clinician, physician or technician in the form of a tuning map comprising a two-dimensional representation of a three-dimensional graph relating motor symptom severity and/or therapeutic side-effect severity to DBS parameter settings.

16. The method of claim 15, wherein the data and/or second level DBS parameters are reviewed and approved by a clinician, physician or technician prior to entry of the second level of DBS parameters into the programmer device in communication with the subject'"'"'s therapy device.