Method and apparatus for treating chronic pain syndromes, tremor, dementia and related disorders and for inducing electroanesthesia using high frequency, high intensity transcutaneous electrical nerve stimulation

• US 6,161,044 A
• Filed: 11/23/1998
• Issued: 12/12/2000
• Est. Priority Date: 11/23/1998
• Status: Expired due to Term

• Current Assignee: The Synaptic Corp.
• Original Assignee: The Synaptic Corp.
• Inventors: Silverstone, Leon M.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US09/199,073
• Time in Patent Office: 750 Days
• Field of Search: 607/45, 607/63, 607/68, 600/554
• US Class Current: 607/45
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition

Abstract

Provided herein is a non-invasive method of treating, controlling or preventing medical, psychiatric or neurological disorders, using transcutaneous electrical stimulation. The method employs a plurality of stimulation frequency parameters, ranging from a relatively high frequency, for example about 40,000 Hertz, to a relatively low frequency, for example about 250 Hertz, the entire plurality of frequency parameters being administered at each of a plurality of stimulation intensity levels. In particular, the method involves stimulating at a first highest frequency parameter and a first lowest intensity parameter, incrementally decreasing the stimulation frequency parameter a lowest frequency parameter, increasing the frequency parameter to the highest frequency parameter and increasing the intensity parameter to a next highest intensity parameter, and again stimulating through the plurality of frequency parameters from the highest frequency to the lowest frequency. The method described herein is useful in treating, controlling and/or preventing various disease states and disorders, including without limitation, tremor disorders, such as essential tremor and Parkinson'"'"'s disease, dementia disorders, such as Alzheimer'"'"'s disease and painful degenerative disorders, such as reflex sympathetic dystrophy and fibromyalgia.

Claims

1. A non-invasive method of treating, controlling or preventing medical, psychiatric or neurological disorders, using transcutaneous electrical stimulation, which method comprises

affixing an electrode pair to the skin of a patient to be treated, which electrode pair is associated with a pulse generator such that stimulation at a desired frequency and intensity may be provided to the patient through said electrode pair, and

thereafter carrying out the following steps of:

a) stimulating at a first highest frequency parameter and a first lowest intensity parameter;

b) decreasing the stimulation frequency parameter to a lowest frequency parameter over a desired time period at said intensity parameter;

c) increasing the frequency parameter to the highest frequency parameter and increasing the intensity parameter to a next higher intensity parameter; and

d) repeating step (b).

2. The method of claim 1, wherein the method is employed to treat, control or prevent a disorder selected from the group consisting of essential tremor and Parkinson'"'"'s disease and the step of decreasing the stimulation frequency parameter over a desired time period (T) comprises decreasing the stimulation frequency parameter about 70% of the total decrease during the first 0.1T, then decreasing it about 5% of the total during the next 0.1T and then linearly decreasing it for about 20% of the total during the next 0.7T.

3. The method of claim 1, wherein the method is employed to treat, control or prevent a disorder selected from the group consisting of essential tremor and Parkinson'"'"'s disease and wherein the step of incrementally decreasing the stimulation frequency parameter is performed for a time duration (T) and comprises the steps of:

a) steadily decreasing the stimulation frequency parameter about 70% over the time period 0.1T;

b) steadily decreasing the stimulation frequency parameter about 5% over the time period 0.1T;

c) steadily decreasing the stimulation frequency parameter about 20% over the time period 0.7T; and

d) steadily decreasing the stimulation frequency parameter the remaining about 5% over the remaining time period of 0.1T;

wherein the percentages are of the total frequency parameter range from the lowest frequency parameter to the highest frequency.

4. The method of claim 3, wherein steps (a), (b) and (c) are performed using the highest frequency parameter of about 40,000 Hertz and the lowest frequency parameter of about 250 Hertz.

5. The method of claim 1, wherein the method is employed to treat, control or prevent a disorder selected from the group consisting of Alzheimer'"'"'s disease, cortical dementia, subcortical dementia and multi-infarct dementia and wherein the step of incrementally decreasing the stimulation frequency parameter is performed for a time duration (T) and comprises the steps of:

a) steadily decreasing the stimulation frequency parameter about 66% over the time period 0.1T;

b) steadily decreasing the stimulation frequency parameter about 23% over the time period 0.2T;

c) steadily decreasing the stimulation frequency parameter about 5.5% over the time period 0.1T; and

d) steadily decreasing the stimulation frequency parameter the remaining about 5.5% over the remaining time period of 0.6T;

wherein the percentages are of the total frequency parameter range from the lowest frequency parameter to the highest frequency.

6. The method of claim 5, wherein the highest frequency parameter is about 40,000 Hertz and the lowest frequency parameter is about 250 Hertz.

7. The method of claim 1, wherein the method is employed to treat, control or prevent a disorder selected from the group consisting of fibromyalgia, reflex sympathetic dystrophy, general acute pain and chronic pain and wherein the step of incrementally decreasing the stimulation frequency parameter is performed for a time duration (T) and comprises the steps of:

a) steadily decreasing the stimulation frequency parameter about 66% over the time period 0.1T;

b) steadily decreasing the stimulation frequency parameter about 13% over the time period 0.1T;

c) steadily decreasing the stimulation frequency parameter about 6% over the time period 0.1T;

d) steadily decreasing the stimulation frequency parameter about 5% over the time period 0.2T; and

d) steadily decreasing the stimulation frequency parameter the remaining about 10% over the remaining time period of 0.5T;

wherein the percentages are of the total frequency parameter range from the lowest frequency parameter to the highest frequency.

8. The method of claim 7, wherein the highest frequency parameter is about 40,000 Hertz and the lowest frequency parameter is about 2,500 Hertz.

9. A non-invasive method of treating tremor disorders using transcutaneous electrical stimulation, which method comprises

affixing two stimulation electrodes to the skin of a patient to be treated, which stimulation electrodes are associated with a pulse generator such that a plurality of frequencies ranging from a highest to a lowest may be administered to the patient at a plurality of intensities, and

thereafter carrying out the following steps:

(a) beginning stimulation of the patient using said highest frequency and a first low intensity;

(b) then incrementally decreasing the stimulation frequency from said highest frequency to said lowest frequency;

(c) then, after reaching said lowest frequency of stimulation, returning to said highest frequency and increasing the intensity to a next higher intensity; and

(d) then repeating step (b) at said increased intensity and step (c).

10. The method according to claim 9 for treating essential tremor disorders wherein during step (b) the stimulation frequency is decreased according to a frequency curve which is equivalent to that defined by the set of decreasing frequency levels specified in Table C, which levels are individually sequentially reached following the elapse of equal time increments from 0.0 to 9.5.

11. The method according to claim 10 wherein said different intensity levels constitute about equal increments of change of intensity.

12. The method according to claim 11 wherein step (b) is performed using about 400 Hz as said lowest frequency and so that stimulation at each said intensity level lasts for at least about 1 minute and wherein steps (c) and (d) are carried out in a manner that none of said plurality of next higher intensities exceeds about 150 volts.

13. The method according to claim 9 wherein step (a) is performed using about 40,000 Hz as said highest frequency and wherein step (b) is performed using about 400 Hz as said lowest frequency.

14. The method of claim 9 wherein step (b) of decreasing the stimulation frequency is performed over a time duration (T) and comprises the individual steps of:

(i) steadily decreasing the stimulation frequency about 70% of the total range between said highest frequency and said lowest frequency over a first time period of 0.1T;

(ii) then, steadily decreasing the stimulation frequency another about 5% of said total range over a second time period 0.1T;

(iii) then, steadily decreasing the stimulation frequency another about 20% of said total range over a time period of 0.7T; and

(iv) finally steadily decreasing the stimulation frequency the remaining about 5% of said total range over a time period of 0.1T.

15. The method according to claim 14 for treating Parkinson'"'"'s disease wherein step (b) comprises decreasing the stimulation frequency according to a frequency curve which is equivalent to that defined by the following set of decreasing approximate frequency levels, which levels are individually sequentially reached following the elapse of equal time increments:

40,000 Hz;

21,000 Hz;

10,000 Hz;

9,100 Hz;

8,500 Hz;

8,000 Hz;

7,500 Hz;

6,500 Hz;

6,000 Hz;

5,500 Hz;

5,000 Hz;

4,500 Hz;

4,000 Hz;

3,500 Hz;

3,000 Hz;

2,500 Hz;

2,000 Hz;

1,500 Hz;

1,000 Hz;

500 Hz;

400 Hz.

16. The method according to claim 14 wherein said treatment at said different stimulation intensities is carried out over a period of at least about 45 minutes.

17. A non-invasive method of treating tremor disorders using transcutaneous electrical stimulation, which method comprises

affixing two stimulation electrodes to the skin of a patient to be treated, which stimulation electrodes are associated with a pulse generator such that stimulation at a plurality of frequencies ranging from a highest to a lowest may be provided to the patient, and

thereafter carrying out the following steps:

(a) beginning stimulation of the patient using said highest frequency which is between about 40,000 Hz and about 60,000 Hz and a first low intensity;

(b) then incrementally decreasing the stimulation frequency from said highest frequency to said lowest frequency;

(c) then, after reaching said lowest frequency, returning to said highest frequency and increasing the intensity to a next higher intensity; and

(d) then repeating step (b) using said increased intensity,

so that said method of treating utilizes a plurality of intensities over a range of at least about 50 volts and extends over a period of at least about 45 minutes, with each step (b) lasting for at least about 1 minute.

18. The method of claim 17 wherein step (b) is performed at least about ten times at different intensities beginning at a highest frequency of about 40,000 Hertz and decreasing to a lowest frequency of about 400 Hertz, and wherein each step (b) of incrementally decreasing the frequency takes place over an independently selected time period.

19. The method of claim 17 wherein step (b) is performed over a time period which is about the same or longer than the previous step (b) time period.

20. The method of claim 17 wherein step (b) is performed at ten different intensities designated 1-10, with 1 being the lowest intensity and 10 being the highest intensity, and wherein step (b) is performed in about one minute at intensity 1, in about 2 minutes for each at intensities 2 and 3, in about 4 minutes for each at intensities 4-7, and in about 8 minutes for each at intensities 8-10.