Movement disorder symptom control

• US 10,820,819 B2
• Filed: 06/29/2018
• Issued: 11/03/2020
• Est. Priority Date: 01/17/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Afshar, Pedram, Denison, Timothy J., Linde, David E., Stanslaski, Scott R.
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US16/023,508
• Publication Number:
  US 20180304082A1
• Time in Patent Office: 858 Days
• CPC Class Codes: A61B 5/291 for electroencephalography [EEG]
• CPC Class Codes: A61B 5/316 Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/4082 Diagnosing or monitoring movement diseases, e.g. Parkinson, Huntington or Tourette
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: G16H 20/30 relating to physical therapies or activities, e.g. physiotherapy, acupressure or exercising
• 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 20/70 relating to mental therapies, e.g. psychological therapy or autogenous training
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The disclosure describes a method and system or controlling symptoms of patients suffering from Parkinson'"'"'s Disease. In some examples, one or more biomarkers indicative of a patient'"'"'s present symptoms are determined. The biomarkers may be used to control therapy delivered to the patient in a closed-loop manner. In addition, biomarkers may be used as an indication of therapy effectiveness.

Claims

1. A method comprising:

acquiring, with a medical device, a plurality of electrical signals from a brain of a patient being treated for a movement disorder with a medication and electrical stimulation, wherein at least one electrical signal of the plurality of electrical signals is acquired from a motor cortex of the brain and at least one electrical signal of the plurality of electrical signals is acquired from a subthalamic nucleus (STN) of the brain;

determining whether at least a first predetermined biomarker is present in a first set of electrical signals of the plurality of electrical signals, the first predetermined biomarker associated with at least one of the patient being over-treated or the presence of side effects of the medication;

determining whether at least a second predetermined biomarker is present in a second set of electrical signals of the plurality of electrical signals, the second predetermined biomarker associated with at least one of the patient being under-treated or the presence of movement disorder symptoms, the second set of electrical signals comprising the at least one electrical signal acquired from the STN, the second predetermined biomarker comprises a low beta band peak in the at least one electrical signal acquired from the STN, wherein the first set of electrical signals is not identical to the second set of electrical signals; and

titrating, based on whether or not the first predetermined biomarker is present and whether or not the second predetermined biomarker is present, at least one therapy parameter of the electrical stimulation to maintain the patient within a therapeutic window in which movement disorder symptoms and side effects of the medication are reduced.

2. The method of claim 1, wherein titrating the at least one therapy parameter comprises adjusting a frequency of electrical stimulation.

3. The method of claim 2, wherein adjusting a frequency of electrical stimulation comprises adjusting the frequency to at least one of:

a frequency of the first predetermined biomarker based on the first predetermined biomarker being present;

a frequency of the second predetermined biomarker based on the second predetermined biomarker being present;

approximately 55-65 Hz;

or approximately 120-140 Hz.

4. The method of claim 2, wherein the method further comprises delivering electrical stimulation to a patient at the adjusted frequency.

5. The method of claim 4, further comprising delivering electrical simulation to the STN of the brain of the patient at the adjusted frequency.

6. The method of claim 1, wherein titrating at least one therapy parameter comprises delivering electrical stimulation at alternating frequencies.

7. The method of claim 6, wherein delivering electrical stimulation at alternating frequencies comprises delivering electrical stimulation alternating between frequencies of approximately 55-65 Hz and approximately 120-140 Hz.

8. The method of claim 1, wherein the first set of electrical signals comprises a the at least one electrical signal acquired from the motor cortex of the brain of the patient.

9. The method of claim 1, wherein titrating the at least one therapy parameter comprises titrating the at least one therapy parameter at a first time, and the method further comprising:

acquiring, after the first time, an updated first set of electrical signals;

acquiring, after the first time, an updated second set of electrical signals;

determining whether at least the first predetermined biomarker is present in the updated first set of electrical signals;

determining whether at least the second predetermined biomarker is present in the updated second set of electrical signals;

analyzing the efficacy of the titrated therapy parameter based on whether the first predetermined biomarker is present in the updated first set of electrical signals or second predetermined biomarker is present in the updated second set of electrical signals; and

re-titrating the at least one therapy parameter based on the efficacy of the titrated at least one therapy parameter.

10. The method of claim 1, wherein the first predetermined biomarker and the second predetermined biomarker are patient specific.

11. The method of claim 10, further comprising:

identifying, based on electrical signals acquired from the brain of the patient, the first predetermined biomarker and the second predetermined biomarker.

12. A system comprising:

an implantable medical device comprising a memory and a processor; and

a plurality of electrodes in communication with the implantable medical device, the plurality of electrodes configured to be implanted in a brain of a patient being treated for a movement disorder with a medication and electrical stimulation;

wherein the processor is configured to;

acquire, via the plurality of electrodes, a plurality of electrical signals, wherein at least one electrical signal of the plurality of electrical signals is acquired from a motor cortex of the brain and at least one electrical signal of the plurality of electrical signals is acquired from a subthalamic nucleus (STN) of the brain;

determine whether at least a first predetermined biomarker is present in a first set of electrical signals of the plurality of electrical signals, the first predetermined biomarker associated with at least one of the patient being over-treated or the presence of side effects of the medication;

determine whether at least a second predetermined biomarker is present a second set of electrical signals of the plurality of electrical signals, the second predetermined biomarker associated with at least one of the patient being under-treated or the presence of movement disorder symptoms, the second set of electrical signals comprising the at least one electrical signal acquired from the STN, the second predetermined biomarker comprises a low beta band peak in the at least one electrical signal acquired from the STN, wherein the first set of electrical signals is not identical to the second set of electrical signals; and

titrate, based on whether or not the first predetermined biomarker is present and whether or not the second predetermined biomarker is present, at least one therapy parameter of the electrical stimulation to maintain the patient within a therapeutic window in which movement disorder symptoms and side effects of the medication are reduced.

13. The system of claim 12, wherein, to titrate the at least one therapy parameter, the processor is further configured to adjust a frequency of electrical stimulation.

14. The system of claim 13, wherein, to adjust the frequency of the electrical stimulation, the processors is configured to adjust the frequency of the electrical stimulation to alternate between frequencies of approximately 55-65 Hz and approximately 120-140 Hz.

15. The system of claim 13, wherein the processor is further configured to adjust the frequency to at least one of:

a frequency of the first predetermined biomarker based on the first predetermined biomarker being present;

a frequency of the second predetermined biomarker based on the second predetermined biomarker being present;

approximately 55-65 Hz;

or approximately 120-140 Hz.

16. The system of claim 13, further comprising a stimulation generator configured to deliver electrical stimulation to the patient at the adjusted frequency.

17. The system of claim 16, wherein the stimulation generator is configured to deliver the electrical stimulation to the STN of the brain of the patient at the adjusted frequency via one or more of the plurality of electrodes.

18. The system of claim 12, wherein, to titrate the at least one therapy parameter, the processor is configured to cause the implantable medical device to deliver electrical stimulation at alternating frequencies.

19. The system of claim 12, wherein the first set of electrical signals comprises the at least one electrical signal from the motor cortex of the brain of the patient.

20. The system of claim 12, wherein, to titrate the at least one therapy parameter, the processor is configured to titrate the at least one therapy parameter at a first time, wherein the processor is further configured to:

acquire, after the first time, an updated first set of electrical signals;

acquire, after the first time, an updated second set of electrical signals;

determine whether at least the first predetermined biomarker is present in the updated first set of electrical signals;

determine whether at least the second predetermined biomarker is present in the updated second set of electrical signals;

analyze the efficacy of the adjusted therapy parameter based on whether or not the first predetermined biomarker is present in the updated first set of electrical signals and whether or not the second predetermined biomarker is present in the updated second set of electrical signals; and

re-titrate the at least one therapy parameter based on the efficacy of the titrated at least one therapy parameter.

21. A system comprising:

means for acquiring, with a medical device, a plurality of electrical signals from a brain of a patient being treated for a movement disorder with a medication and electrical stimulation, wherein at least one electrical signal of the plurality of electrical signals is acquired from a motor cortex of the brain and at least one electrical signal of the plurality of electrical signals is acquired from a subthalamic nucleus (STN) of the brain;

means for determining whether at least a first predetermined biomarker is present in a first set of electrical signals of the plurality of electrical signals, the first predetermined biomarker associated with at least one of the patient being over-treated or the presence of side effects of the medication;

means for determining whether at least a second predetermined biomarker is present in a second set of electrical signals of the plurality of electrical signals, the second predetermined biomarker associated with at least one of the patient being under-treated or the presence of movement disorder symptoms, the second set of electrical signals comprising the at least one electrical signal acquired from the STN, the second predetermined biomarker comprises a low beta band peak in the at least one electrical signal acquired from the STN, wherein the first set of electrical signals is not identical to the second set of electrical signals; and

means for titrating, based on whether or not the first predetermined biomarker is present and whether or not the second predetermined biomarker is present, at least one therapy parameter of the electrical stimulation to maintain the patient within a therapeutic window in which movement disorder symptoms and side effects of the medication are reduced.