Method and system for tuning of movement disorder therapy devices

• US 9,662,502 B2
• Filed: 06/03/2011
• Issued: 05/30/2017
• Est. Priority Date: 10/14/2008
• 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 A
• Application Number:
  US13/153,063
• Publication Number:
  US 20130123684A1
• Time in Patent Office: 2,188 Days
• Field of Search: 705 2- 3
• 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 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/1101 Detecting tremor
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A system and method for tuning the parameters of a therapeutic medical device comprises a movement measurement data acquisition system capable of wireless transmission; processing comprising kinematic feature extraction, a scoring algorithm trained using scores from expert clinicians, a therapeutic device parameter setting adjustment suggestion algorithm preferably trained using the parameter setting adjustment judgments of expert clinicians; and a display and/or means of updating the parameter settings of the treatment device. The invention facilitates the treatment of movement disorders including Parkinson'"'"'s disease, essential tremor and the like by optimizing deep brain stimulation (DBS) parameter settings, eliminating as much as possible motor symptoms and reducing time and costs of surgical and outpatient procedures and improving patient outcomes. In preferred embodiments, the system provides recommendations for treatment which may be semi-automatically or automatically applied to update the parameter settings of a treatment device such as a DBS implant.

Claims

1. A method for adjusting brain stimulation electrodes in a subject for treating a subject'"'"'s movement disorder comprising the steps of:

applying at least one sensor having a signal to measure at least one motor symptom of a subject'"'"'s movement disorder, the sensor having an implanted brain stimulation device for treatment of a movement disorder;

quantifying at least one motor symptom of the subjects movement disorder with the signal from the at least one sensor using a processor;

outputting the quantification of the at least one motor symptom to a display; and

adjusting the implanted brain stimulation device for treatment of the movement disorder based at least in part on the outputted quantification of the at least one motor symptom to alleviate in part the at least one motor symptom,

wherein at least two sensors are applied to a finger of the post-surgical subject, the sensors include both an accelerometer and a gyroscope, and the sensors applied to the finger of the post-surgical subject are packaged in an enclosure, the enclosure and sensors altogether having a volume of no more than or about 12 cubic centimeters and a mass of no more than or about 12 grams.

2. The method of claim 1, wherein the quantification of at least one motor symptom of the subject'"'"'s movement disorder is based at least in part on historical data.

3. The method of claim 2, wherein the historical data comprises scores based on the Unified Parkinson'"'"'s Disease Rating Scale (UPDRS) assigned to movement disorder patients by at least one expert clinician.

4. The method of claim 1, wherein the adjustment made to the implanted brain stimulation device is based at least in part on historical data.

5. The method of claim 4, wherein the historical data comprises recorded adjustments made to brain stimulation devices implanted in movement disorder patients, said recorded adjustments made by at least one expert clinician.

6. A system for adjusting the parameters of a deep brain stimulation device implanted in a subject for treating a subject'"'"'s movement disorder by a clinician after surgery, the system comprising:

a sensor unit comprising an accelerometer and/or gyroscope for quantifying at least one symptom of a subject'"'"'s movement disorder, the sensor unit being protected by an enclosure and the sensor unit having an analog signal related to the movement of the subject with a movement disorder, the subject having a deep brain stimulation implant having adjustable parameters;

a command module for receiving the analog signal acquired by the sensor unit, the electronic module comprising a memory and an analog-to-digital converter for converting the analog signal into a digital signal corresponding to the at least one quantified motor symptom; and

a clinician unit for receiving the digital signal and for processing the signal acquired by the sensor unit, for receiving an input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings during measurement of the analog signal with the sensor unit, and to produce an output comprising computed adjustments for one or more of the adjustable parameters of the deep brain stimulation implant, the output being based at least in part on the signal acquired by the sensor and at least in part on the input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings; and

a display or receiving the output,

wherein the command module has a mass of no more than or about 85 grams.

7. The system of claim 6, wherein the clinician unit additionally comprises electronic components for wirelessly transmitting the output to the deep brain stimulation implant via Bluetooth.

8. The system of claim 7, wherein the wireless transmission of the output to the deep brain stimulation implant is executed following a manual or vocal confirmation made to the user interface after showing a proposed adjustment on the display.

9. The system of claim 6, wherein the clinician unit comprises one of a PDA, or a smartphone.

10. The system of claim 6, wherein the output of the clinician unit is computed using one or any combination of the following;

an artificial neural network, adaptive continuous learning algorithms, linear quadratic Gaussian control, Kalman filtering, and model predictive control.

11. A system for adjusting the parameters of a deep brain stimulation device implanted in a subject for treating a subject'"'"'s movement disorder by a clinician after surgery, the system comprising:

a sensor unit comprising an accelerometer and/or gyroscope for quantifying at least one symptom of a subject'"'"'s movement disorder, the sensor unit being protected by an enclosure and the sensor unit having an analog signal related to the movement of the subject with a movement disorder, the subject having a deep brain stimulation implant having adjustable parameters;

a command module for receiving the analog signal acquired by the sensor unit, the electronic module comprising a memory and an analog-to-digital converter for converting the analog signal into a digital signal corresponding to the at least one quantified motor symptom; and

a clinician unit for receiving the digital signal and for processing the signal acquired by the sensor unit, for receiving an input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings during measurement of the analog signal with the sensor unit, and to produce an output comprising computerd adjustments for one or more of the adjustable parameters of the deep brain stimulation implant, the output being based at least in part on the signal acquired by the sensor and at least in part on the input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings; and

a display for receiving the output,

wherein the sensor unit comprises at least one accelerometer and at least one gyroscope and has a volume of no more than or about 12 cubic centimeters and a mass of no more than or about 12 grams.

12. A system for adjusting the parameters of a deep brain stimulation device implanted in a subject for treating a subject'"'"'s movement disorder by a clinician after surgery, the system comprising:

a sensor unit comprising an accelerometer and/or gyroscope the quantifying at least one symptom of a subject'"'"'s movement disorder, the sensor unit being protected by an enclosure and the sensor unit having an analog signal related to the movement of the subject with a movement disorder, the subject having a deep brain stimulation implant having adjustable parameters;

a command module for receiving the analog signal acquire by the sensor unit, the electronic module comprising a memory and an analog-to-digital converter for converting the analog signal into is digital signal corresponding to the at least one quantified motor symptom; and

a clinician unit for receiving the digital signal and for processing the signal acquired by the sensor unit, for receiving an input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings during measurement of the analog signal with the sensor unit, and to produce an output comprising computed adjustments for one or more of the adjustable parameters of the deep brain stimulation implant, the output being based at least in part on the signal acquired by the sensor and at least in part on the input related to the subject'"'"'s deep brain stimulation implant'"'"'s parameter settings; and

a display for receiving the output,

wherein the sensor unit and command module are integrated into the same enclosure having a volume of no more than or about 82 cubic centimeters and a mass of no more than or about 97 grams.