Vagus nerve stimulation by electrical signals for controlling cerebellar tremor

• US 7,996,088 B2
• Filed: 07/26/2006
• Issued: 08/09/2011
• Est. Priority Date: 07/26/2006
• Status: Expired due to Fees

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Marrosu, Maria Giovanna, Marrosu, Francesco
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): SARCIONE, JESSICA LYNN
• Application Number:
  US11/460,155
• Publication Number:
  US 20080027503A1
• Time in Patent Office: 1,840 Days
• Field of Search: 607/45, 607 48- 50, 607/62, 607/118, 600544-548
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease

Abstract

A neurostimulator system for alleviating cerebellar tremor associated with multiple sclerosis, for instance, comprises a programmable electrical pulse generator. The programmable electrical pulse generator is programmed to generate electrical signals with the following parameters: a current magnitude of about 1 mA or less, a stimulation signal on-time to signal off-time ratio in the range of 2:1 to 1:1.8, signal on-times and off-times in the range of about 10 seconds to about 5 minutes, a signal frequency below 15 Hz, and a pulse width within the range of 50 μs to 300 μs. Other embodiments are disclosed and claimed.

Claims

1. A neurostimulator system for alleviating cerebellar tremor, comprising:

a programmable electrical pulse generator; and

at least one electrode connected to the programmable electrical pulse generator and configured to apply electrical signals to a cranial nerve; and

wherein

the programmable electrical pulse generator is programmed to generate electrical signals with a combination of parameters that is effective in reducing cerebellar tremor, the combination of parameters comprising;

a signal frequency of 15 Hz or less,

a current magnitude of about 1 mA or less,

a stimulation signal on-time to signal off-time ratio in the range of 2;

1 to 1;

1.8;

signal on-times and off-times in the range of about 10 seconds to about 5 minutes, and

a pulse width within the range of 50 μ

s to 300 μ

s.

2. The neurostimulator system according to claim 1, further comprising:

an electroencephalographic sensor configured to detect a presence, onset, or precursors of cerebellar tremor associated with multiple sclerosis by sensing electroencephalographic waves and to output at least one first sensor signal to the electrical pulse generator, wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one first sensor signal.

3. The neurostimulator system according to claim 1, further comprising:

a tremor sensor connected with the programmable electrical pulse generator and configured to sense tremor associated with multiple sclerosis, to generate at least one second sensor signal, and to transmit the at least one second sensor signal to the programmable electrical pulse generator, wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one second sensor signal.

4. The neurostimulator system according to claim 1, further comprising

a muscular sensor connected with the programmable electrical pulse generator and configured to sense muscle activity, to generate at least one third sensor signal and to transmit the at least one third sensor signal to the programmable electrical pulse generator, wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one third sensor signal.

5. The neurostimulator system according to claim 1, wherein the at least one electrode comprises a first electrode and a second electrode wherein the first electrode has a negative potential with respect to the second electrode.

6. The neurostimulator system of claim 1, wherein the programmable electrical pulse generator is programmed to generate signals with the following parameters:

a signal frequency of about 10 Hz;

a current magnitude of about 1 mA;

a pulse width of about 250 μ

s;

a signal on time of about 60 seconds; and

a signal on-time to signal off-time ratio of about 1;

1.

7. A method for manufacturing a neurostimulator system intended for alleviating cerebellar tremor associated with multiple sclerosis, comprising:

providing a programmable electrical pulse generator;

programming the programmable electrical pulse generator to generate electrical signals effective to control cerebellar tremor when said signals are applied to a cranial nerve of a patient suffering from cerebellar tremor; and

providing at least one electrode connected with the programmable electrical pulse generator for applying the electrical signals generated by the electrical pulse generator to a cranial nerve for controlling cerebellar tremor,

wherein the programmable electrical pulse generator is programmed to generate electrical signals having a current magnitude of about 1 mA or less, a stimulation signal on-time to signal off-time ratio in the range of 2;

1 to 1;

1.8, signal on-times and off-times in the range of about 10 seconds to about 5 minutes, a signal frequency below a frequency of 15 Hz, and a pulse width within the range of 50 μ

s to 300 μ

s.

8. The method according to claim 7, wherein the electrical signals are pulsed waveform signals.

9. The method according to claim 7, wherein programming the pulse generator comprises providing for the electrical signals to be delivered continuously or periodically or intermittently and/or on the patient'"'"'s demand.

10. The method according to claim 7, wherein the programmable electrical pulse generator is programmed by programmable parameters comprising a pulse width and/or a current magnitude and/or a pulse frequency and/or stimulation on-time and/or stimulation off-time.

11. The method according to claim 7, wherein the at least one electrode comprises a first electrode and a second electrode, wherein the first electrode has a negative potential with respect to the second electrode.

12. The method according to claim 7, further comprising providing a sensor configured to sense a presence, onset, or precursors of cerebellar tremor by sensing electroencephalographic waves and to output at least one first sensor signal to the electrical pulse generator, wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one first sensor signal.

13. The method according to claim 7, further comprising providing a muscular sensor configured to sense a presence, onset, or precursors of cerebellar tremor by sensing spontaneous muscle activity and to output at least one muscle sensor signal to the electrical pulse generator, wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one muscle sensor signal.

14. The method according to claim 7, wherein the operation of programming the programmable electrical pulse generator to generate electrical signals effective to control cerebellar tremor comprises programming the programmable electrical pulse generator to generate electrical signals with attributes comprising:

current magnitude of about 1 mA;

signal frequency of about 10 Hz;

pulse width of about 250 μ

s;

signal on time of about 60 seconds; and

signal on-time to signal off-time ratio of about 1;

1.

15. A method of treating a patient suffering from cerebellar tremor, comprising:

providing a neurostimulator system comprising a programmable electrical pulse generator comprising at least one electrode for applying electrical signals generated by the electrical pulse generator, wherein said pulse generator is programmed with signal parameters comprising a pulse width, a current magnitude, a pulse frequency, stimulation on-time and stimulation off-time effective to attenuate or control cerebellar tremor in the patient;

placing said electrode in electrical communication with a cranial nerve of the patient; and

applying said electrical signals to said cranial nerve by means of the at least one electrode, said application of said electrical signals being effective to attenuate or control the cerebellar tremor;

wherein the following programmable parameters are used;

current magnitude of about 1 mA or less;

pulse width within the range of 50 μ

s to 300 μ

s;

signal frequency below 15 Hz;

signal on-times and off-times in the range of about 10 seconds to about 5 minutes; and

a stimulation signal on-time to signal off-time ratio in the range of 2;

1 to 1;

1.8.

16. The method according to claim 15, wherein the cerebellar tremor is associated with multiple sclerosis.

17. The method according to claim 15, wherein the electrical signals are pulsed waveform signals.

18. The method according to claim 15, wherein the electrical signals are applied continuously or periodically or intermittently and/or on the patient'"'"'s demand.

19. The method according to claim 15, wherein said at least one electrode comprises first and second electrodes and the electrical signals are applied by said first electrode and said second electrode wherein the first electrode has a negative potential with respect to the second electrode and wherein the first electrode is applied proximal to the patient'"'"'s brain and the second electrode is applied distal to the patient'"'"'s brain with respect to the first electrode.

20. The method according to claim 15, wherein the neurostimulator system comprises a sensor configured to sense an onset or precursors of cerebellar tremor and wherein the electrical pulse generator is configured to generate electrical signals on the basis of at least one first sensor signal,

said method further comprising sensing electroencephalographic waves and outputting at least one first sensor signal to the electrical pulse generator.

21. The method according to claim 15, wherein the neurostimulator system comprises a muscular sensor configured to sense an onset or precursors of cerebellar tremor by sensing muscle activity and to output at least one muscular sensor signal to the electrical pulse generator, and wherein the electrical pulse generator is configured to generate electrical signals on the basis of the at least one muscular sensor signal.

22. The method according to claim 15, wherein:

the current magnitude is set to about 1 mA;

signal frequency is set to about 10 Hz;

pulse width is set to about 250 μ

s;

signal on time is set to about 60 seconds; and

signal on-time to signal off-time ratio is set to about 1;

1.

23. A non-transitory computer program product, comprising:

one or more non-transitory computer readable media having computer-executable instructions for controlling a programmable electrical pulse generator to generate electrical signals to be applied to a cranial nerve, the computer-executable instructions configured to cause the electrical signals to have attributes comprising;

a current magnitude about 1 mA or less,

a stimulation signal on-time to signal off-time ratio in the range of 2;

1 to 1;

1.8,

signal on-times and off-times in the range of about 10 seconds to about 5 minutes,

a signal frequency below 15 Hz, and

a pulse width within the range of 50 μ

s to 300 μ

s.

24. A non-transitory computer program product according to claim 23, wherein the computer-executable instructions are configured to cause the electrical signals to have attributes comprising:

current magnitude of about 1 mA;

signal frequency of about 10 Hz;

pulse width of about 250 μ

s;

signal on time of about 60 seconds; and

signal on-time to signal off-time ratio of about 1;

1.