Vagus Nerve Stimulation by Electrical Signals for Controlling Cerebellar Tremor

• US 20080027503A1
• Filed: 07/26/2006
• Published: 01/31/2008
• Est. Priority Date: 07/26/2006
• Status: Active Grant

• Current Assignee: Cyberonics, Inc
• Original Assignee: Cyberonics, Inc
• Inventors: Marrosu, Maria Giovanna, Marrosu, Franco
• Granted Patent: US 7,996,088 B2
• Time in Patent Office: Days
• 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

The present invention provides a neurostimulator system for alleviating cerebellar tremor, in particular, associated with multiple sclerosis, comprising a programmable electrical pulse generator; and at least one electrode connected with the programmable electrical pulse generator; and wherein the programmable electrical pulse generator is programmed to generate electrical signals with the following parameters: a current magnitude of not above 3 mA, in particular, not above 1 mA, a stimulation signal on-time to signal off-time ratio in the range of about 2:1 to about 1:2, and signal on-times and off-times in the range of about 10 seconds to about 5 minutes, a signal frequency below 30 Hz, and a pulse width within the interval of 50 μs to 500 μs. A method for manufacturing a neurostimulator system for alleviating cerebellar tremor associated with multiple sclerosis is also disclosed.

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

wherein

the programmable electrical pulse generator is programmed to generate electrical signals with the following parameters;

a signal frequency of 30 Hz or less, particularly 15 Hz or less,

a current magnitude of not above 3 mA, in particular, not above 1 mA,

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

1 to about 1;

2, and 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 500 μ

s.

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

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

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

6. 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.

7. The method according to claim 6, wherein the cerebellar tremor is associated with multiple sclerosis.

8. The method according to claim 6, wherein the electrical signals are pulsed waveform signals.

9. The method according to claim 6, 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 6, 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 10, wherein the following programmable parameters are chosen as:

a current magnitude of not above 3 mA, in particular, not above 1 mA,

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

1 to about 1;

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

a signal frequency below a frequency of 30 Hz, and

a pulse width within the interval of 50 μ

s to 500 μ

s.

12. The method according to claim 6, wherein the neurostimulator system comprises a first electrode and a second electrode and wherein the first electrode has a negative potential with respect to the second electrode.

13. The method according to claim 6, further comprising providing a sensor configured to sense the presence, onset or precursors of cerebellar tremor by sensing the electroencephalographic waves and to output at least one 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 sensor signal.

14. The method according to claim 6, further comprising providing a muscular sensor configured to sense the presence, onset or precursors of cerebellar tremor by sensing the spontaneous muscle activity and to output at least one muscle 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 muscle sensor signal.

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 and/or a current magnitude and/or a pulse frequency and/or stimulation on-time and/or 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, effective to attenuate or control the cerebellar tremor.

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 the following programmable parameters are chosen:

the current magnitude is set to a value not above 3 mA, in particular, not above 1 mA,

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

1 to about 1;

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

the signal frequency is set to a value below 30 Hz, and

the pulse width is set to a value within the interval of 50 μ

s and 500 μ

s.

20. 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 brain and the second electrode is applied distal to the brain with respect to the first electrode.

21. The method according to claim 15, wherein the neurostimulator system comprises a sensor configured to sense the 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 sensor signal,

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

22. The method according to claim 15, wherein the neurostimulator system comprises a muscular sensor configured to sense the onset or precursors of cerebellar tremor by sensing the 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.

23. A computer program product, comprising one or more computer readable media having computer-executable instructions for controlling a programmable electrical pulse generator to generate electrical signals with

a current magnitude in the range of from about 1 mA to about 2 mA,

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

1 to about 1;

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

a signal frequency below 30 Hz, and

a pulse width within the interval of from about 50 μ

s to about 500 μ

s.