Prevention of seizure arising from medical magnetoictal non-convulsive stimulation therapy

• US 6,117,066 A
• Filed: 09/23/1998
• Issued: 09/12/2000
• Est. Priority Date: 12/04/1992
• Status: Expired due to Fees

• Current Assignee: Somatics Incorporated
• Original Assignee: Somatics Incorporated
• Inventors: Abrams, Richard Stephen, Swartz, Conrad Melton
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/159,045
• Time in Patent Office: 720 Days
• Field of Search: 600/9-15, 128/897-98, 607/45
• US Class Current: 600/14
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 2/02 using magnetic fields produced by coils, including single turn loops or electromagnets A61N2/12 takes precedence

Abstract

In non-convulsive magnetic stimulation therapy a patient is treated with magnetic pulses from a coil placed proximate the patient'"'"'s head as a treatment of certain neurologic and psychiatric disorders. A set of EEG (electroencephalograph) electrodes on the patient'"'"'s scalp are switched on during pauses in the electrical pulse train to the coil. If epilepsy-like brain wave spikes and/or sharp waves are detected by the EEG, a warning is given, treatment is halted and an anti-convulsive medicine may be administered.

Claims

1. A method to provide magnetic stimulation to the brain of a patient to treat neuropsychiatric disorders without inducing seizure in the patient comprising:

(a) bringing a magnetic coil into proximity to the patient'"'"'s head and pulsing the coil with electrical pulses to generate a sequence of magnetic fields within the patient'"'"'s brain during a treatment session;

(b) connecting an EEG (electroencephalograph) electrode to the patient'"'"'s scalp to detect the patient'"'"'s brain waves and detecting such brain waves during selected intervals during the treatment session;

(c) detecting in the patient'"'"'s brain waves the onset of epileptic spikes and/or sharp-waves and/or voltage excursions which are at least 2.5 standard deviations above RMS or average voltage level, and

(d) providing a warning of such detection of the epileptic spikes and/or the sharp waves and/or the voltage excursions to halt the treatment session.

2. A method as in claim 1 and, in addition, after (d) treating the patient with a suitable anti-convulsant pharmaceutical agent.

3. A method as in claim 2 wherein the pharmaceutical agent is selected from the group consisting of:

valproic acid, divalproex sodium, carbamazepine, phenytoin, primidone, vigabatrin, topiramate, gabapentin, lamotrigine, felbamate, phenobarbital, amobarbital, secobarbital, methohexital, pentobarbital, diazepam, lorazepam, clonazepam, alprazolam, oxazepam, midazolam, clorazepate, chlordiazepoxide, triazolam, nitrazepam, flurazepam, and temazepam, propofol, propanidid, fentanyl, althesin, thioamylal, and halothane gas.

4. A method as in claim 1 and switching the electrical pulses off and on to generate a series of off periods of at least 2 seconds and, in the treatment session, detecting the patient'"'"'s brain waves only during such off periods.

5. A method as in claim 1 and removably attaching two ECG (electrocardiograph) electrodes to the patient, detecting the patient'"'"'s heart rate, and providing a warning to halt the treatment session if the patient'"'"'s heart rate rises above a selected rate.

6. A method as in claim 5 and deriving and displaying the patient'"'"'s heart rate during the treatment session.

7. A method as in claim 1 and displaying an EEG based indication of the patient'"'"'s condition during the treatment session, selected from one or more of the group of:

(i) EEG displayed as wavy lines, (ii) amount of EEG energy in the high frequency range, (iii) EEG coherence, (iv) peak EEG amplitude, (v) EEG area, (vi) EEG area rate, and (v) maxima and minima of EEG area rate.

8. A method as in claim 1 and generating a summary report after the treatment session, the report being selected from one or more of the group of:

(i) type of stimuli administered, (ii) number of stimuli administered, (iii) EEG measurements, and (iv) ECG measurements.

9. A method as in claim 1 and in (a) about simultaneously generating at least two sequences of magnetic fields;

one sequence at one frequency on one side of the patient'"'"'s brain and the other sequence at a different and higher frequency at the opposite side of the patient'"'"'s brain.

10. A method as in claim 1 and in (c) counting the number of spikes and/or sharp waves in a time segment and, in the event the counted number exceeds a predetermined number, providing the warning of (d).

11. A system to provide magnetic stimulation to the brain of a patient for treatment of a neuropsychiatric disorder without inducing seizure in the patient comprising:

(a) a magnetic coil adapted to be positioned in proximity to the patient'"'"'s head and pulse means for pulsing the coil with electrical pulses to generate a sequence of magnetic fields that induce a sequence of electrical fields within the patient'"'"'s brain during a treatment session;

(b) an EEG (electroencephalograph) electrode adapted to be removably connected to the patient'"'"'s scalp and EEG means to detect the patient'"'"'s brain waves during selected intervals during the treatment session;

(c) means for detecting in the patient'"'"'s brain waves the onset of epileptic spikes and/or sharp-waves and/or voltage excursions which are at least 2.5 standard deviations above RMS or average voltage level, and

(d) warning means for providing a warning to a physician of such detection of the epileptic spikes and/or the sharp-waves and/or the voltage excursions.

12. A system as in claim 11 and, in addition, means to warn a physician after (d) to treat the patient with a suitable anti-convulsive drug.

13. A system as in claim 11 and switch means for switching the electrical pulses off and on to thereby generate a series of off periods each of at least 2 seconds and, in the treatment session, means for detecting the patient'"'"'s brain waves only during such off periods.

14. A system as in claim 11 and an ECG (electrocardiograph) electrode adapted to be removably connected to the patient, heart beat means for detecting the patient'"'"'s heart rate, and heart beat warning means for providing a warning signal to a physician to halt the treatment session if the patient'"'"'s heart rate rises above a selected rate.

15. A system as in claim 14 and means to calculate and display the patient'"'"'s heart rate during the treatment session.

16. A system as in claim 11 and means to calculate and display an EEG based indication of the patient'"'"'s condition during the treatment session, selected from one or more of the group of (i) EEG displayed as wavy lines, (ii) amount of EEG energy in the high frequency range, (iii) EEG coherence, (iv) peak EEG amplitude, (v) EEG area, (vi) EEG area rate and (vii) maxima and minima of the EEG area rate.

17. A system as in claim 11 and in (a) at least first and second magnetic coils positioned proximate opposite sides of the patient'"'"'s head, and means to pulse the first coil with electrical pulses at a low frequency and to about simultaneously pulse the second coil with electrical pulses at a higher frequency.

18. A system as in claim 11 and in (c) means for counting the number of spikes and/or sharp waves in a time segment, comparing the counted number to a predetermined number and, in the event the counted number exceeds the predetermined number, generating a control signal to the warning means to provide the warning of (d).

19. A method of treatment of a patient for certain neurologic and psychiatric disorders, comprising in sequence:

(a) administering an anti-convulsive pharmaceutical agent to the patient and, when the patient has reacted to the anti-convulsive pharmaceutical agent;

(b) treating the patient with a series of magnetic impulses directed at the patient'"'"'s head in a non-convulsive magnetic stimulation therapy session.

20. A method of treatment as in claim 19 wherein the pharmaceutical agent is selected from the group consisting of:

valproic acid, divalproex sodium, carbamazepine, phenytoin, primidone, vigabatrin, topiramate, gabapentin, lamotrigine, felbamate, phenobarbital, amobarbital, secobarbital, methohexital, thiopental, diazepam, lorazepam, clonazepam, alprazolam, oxazepam, midazolam, clorazepate, chlordiazepoxide, triazolam, nitrazepam, flurazepam, halazepam, propofol, propanidid, fentanyl, althesin, thioamylal, and halothane gas.