Note: Descriptions are shown in the official language in which they were submitted.
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1 This invention relates to a method for the relief of
headaches and more particularly relates to use of electrical
stimulation for elimination of extracranial headaches in humans.
It is well known that the application of electrical
stimulation to the body of a human patient may produce therapeutic
and anesthetizing affects, including the inducement of sleep. As
described in U.S. Patent No. 4,014,347 (Halleck et al.) pain may
be suppressed by prolonged stimulation of the nerves involved in
transmittal of the pain signals. To the same effect are U.S. Pat.
10 Nos. 4,084,595 (~iller) and 4,121,594 (Miller et al). In U.S.
Patent No. 3,762,396 (Ballentine et al) sleep may be induced by
application of electrical signals to a human sufferer's head, such
signals to have frequencies associated with the human alpha brain
wave and REM during sleep. Lastly, U.S. Patent No. 3,791,373
(Winkler et al) discloses that a patient may be anesthetized by
application of electrical current. The prior art devices have
utilized various frequencies, including automatic scanning of
frequencies during treatment, and various wave forms; these
variations have frequently been claimed to have eliminated the
20 side effects of such electrical treatment. Also various prior art
devices have been designed with the object of minimizing the power
consumed so that the device may be portable (i.e., operate on
batteries) and of long-life between recharges. But none of these
devices provides a cure for human headaches.
Greater than 90% of all headaches are: (1) headaches
due to painful dilation and distention of cranial arteries; (2)
headaches due to sustained contraction of skeletal muscle about
the face, scalp and neck; or (3) headaches from diseases of the
paranasal spaces ("sinus headaches"). Beeson, P.B., McDermott,
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1 W., Textbook of Medicine, 14th edition, page 616, W.B. Saunders
Co., Philadelphia, 1975. But effective headache relief by the
application of electrical stimulation to the body is not known in
the prior art.
The present invention provides human headache relief by
application of electrical pulses of an approximate frequency of
10-12 pulses per second to a headache sufferer's skin. Ideally,
the pulses are of an amplitude just below the sufferer's pain
tolerance level (typically 60 to 150 volts) and are applied by two
electrodes: a ground electrode makes contact with any skin area
away from the neck or head and a live electrode makes contact with
the sufferer's neck or head, depending on the type headache suffered.
Further, the pulses have a square wave form with the pulse width
approximately 40 microseconds. An application for two minutes is
normal and usually provides at least 6 hours relief.
The accompanying drawings illustrate a preferred embodi-
rnent of the invention according to the best mode so far devised by
the applicant, and in which:
FIG. 1 is a view of a headache sufferer self administering
the method; and
FIG. 2 is a schematic diagram of a typical device which
generates electrical pulses usable with the method.
The preferred embodiment of the inventive method to
relieve a sufferer of a headache is to apply electrical pulses
with the following characteristics:
Frequency: 11 pulses per second
Shape: square wave
Width: 40 microseconds
Amplitude: 50-200 volts (depends
on the individual suf-
ferer, points of
contact, skin moisture,
and pain threshold)
l for a time period of two minutes to the sufferer's neck or head
with a return ground attached to the sufferer's forearm, back or
thigh. The pulse amplitude is empirically selected as described
below and held constant during the application.
Tests conducted with patients who were suffering from
headaches have shown that certain of the pulse parameters are
critical for effective headache relief while others have some
flexibility in allowing a degree of variation from patient to
patient while still producing effective results in relieving the
headache.
First, the pulse must have the characteristics of a
square wave. ~everal other wave descriptions were not successful
in providing relief.
Second, the pulse width or pulse duration may vary from
35-45 microseconds and still achieve positive results; however,
the optimwm width has been identified to be 40 microseconds.
Deviation from that optimum width begins to deteriorate the
effectiveness of the application to a point of being ineffective
if the deviation is greater than 5 microseconds from the 40 micro-
seconds optimum pulse width.
Third, the pulse rate may vary from 10-12 pulses per
second and still achieve positive results; however, the optimum
pulse rate has been identified as 1I pulses per second and any
deviation from that pulse rate begins to deteriorate the ef-
fectiveness of the application to a point of being ineffective if
the deviation is greater than a one pulse per second deviation
from the ll pulses per second optimum pulse rate.
Fourth, the applied pulse amplitude (peak voltage) is
not critical in the narrow sense and will vary from patient to
1 patient depending upon the patient's natural impedance and sensi-
tivity to the discomfort associated with increased voltage application.
The normal range of voltage applied generally runs from 50-lS0
volts, and in some exceptional cases, voltage application may go
as high as 200 volts. With some patients, the "first time application"
causes a degree of apprehension which will cause them to limit the
peak voltage to about 60 volts on the first application. Familiarity
with the process minimizes their apprehension and on subsequent
applications they routinely will achieve a higher applied peak
voltage. Positive results of headache relief have been routinely
achieved throughout the 50-200 volt range with the norm, however,
running in the 50 to 150 volt range.
Lastly, normal time duration for a successful application
is two minutes at peak voltage acceptable to the patient. If the
headache continues after the first two minute application (particu-
larly if peak voltage was low), then a second two minute application
normally resulted in abatement or total relief from the headache.
Applications longer than two two-minute applications have not been
required in the patients treated
FIG. 1 shows headache sufferer 13 connected to headache
relief apparatus 10. The ground electrode 11 is shown placed on
the sufferer's forearm, although positioning on the sufferer's
thigh or back will produce approximately the same results. The
live electrode 12 is shown placed on the back of the sufferer's
neck, although placement on the forehead is preferable for sinus
headaches, and other locations on the head have been successfully
used in some patients. Electrode 12 may be covered with terry
cloth and moistened so that when it is placed in contact with the
sufferer's neck the insulative effect of the intervening hair can
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1 be overcome by the conductivity of the moisture from the terry
cloth. Of course, the moistened terry cloth could be replaced by
any other appropriate conductive medium. Also live electrode 12
may be attached to a handle 14 for easy manipulation -- it should
be noted that due to the sufferer's hair and irregular body surface
about the neck area some manipulation of the live electrode will
be required to insure a good electrical contact. It is believed
that any electrode size, shape, or material that produces a good
electrical contact may be substituted for the particular electrode
sizes, shapes, and materials disclosed without noticeable change
in the results disclosed.
In operation, the sufferer himself or another individual
places the two electrodes 11, 12 in contact with the patient as
depicted in FIG. 1. The frequency of the pulses and the pulse
width are not variable to the sufferer, so the only parameter to
be determined is the pulse amplitude, (i.e. voltage). This insures
easy and efficient use of the method because only one electrical
adjustment is made and misleading adjustments made at frequencies
and pulse widths differing from those of the treatment are avoided.
The pulse amplitude for treatment is determined by increasing the
amplitude from zero until the pain threshold of the sufferer is
reached. Then the amplitude is adjusted so that it is approximately
90 to 95% of the amplitude at the pain threshold or just below the
sufferer's maximum level of discomfort. The sufferer himself can
most effectively make this adjustment as shown in FIG. 1.
As indicated in the examples to follow, the stimulation
is continuous for two minutes, although the average sufferer's
headache has been eliminated prior to this time.
1 26~
1 It is believed tha~ the method by which the invention
relieves vascular headaches is as follows:
The electrical pulses are transmitted through the skin
and subcutaneous tissues stimulating directly the arterial smooth
muscle walls. The stimulation induces a segmental or generalized
contractile response in the artery or arterials, thereby eliminating
the cause of vascular headache pain. The arteries most commonly
affected are the dural branches of the external carotid, temporal,
post-auricular and occipital arteries.
It is believed that the method by which the invention
relieves headaches caused by skeletal muscle contraction is as
follows:
The electrical pulses are transmitted through the skin
and subcutaneous tissues directly to the skeletal muscle tissue.
The ground electrode frequently produces a clonic response in the
skeletal muscle near its site of application. The active electrode
only rarely produces a clonic response but alters the electrical
state of the muscle toward a resting and refractile condition.
Elimination of sustained contraction of the skeletal muscle thereby
eliminates the cause of muscle contraction headache.
That other unknown factors are involved is evldenced by
the prolonged effect (i.e. sustained headache relief) following
discontinuation of the stimulus. This effect (sustained headache
relief) following a brief electrical stimulation is in contrast to
the prior art transcutaneous nerve stimulators which utilize
prolonged stimulation with pain relief terminating on completion
of nerve stimulation.
The present invention is in contrast to the prior art
nerve stimulators which rely on mechanisms of blocking directly or
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1 indirectly afferent pain conducting nerves as opposed to actually
relieving the cause of pain by direct effects on arteries and
skeletal muscles.
1 The fo]lowing examples illustrate the invention:
Patient Applied pulse Duration of Results
__mbe_ _eak_volta~e ap~licatio_ ___ ___
A. Approx. 60volts 2 Minutes Cured for
at least 6 hrs.
B. Approx. 60volts 2 Minutes Cured. The
patient was subject
to daily headaches.
Her headaches
were absent for
four days following
treatment.
C. Approx. 50volts 2 Minutes 80% Cured.
3 Minutes 100% Cured
for at least
6 hrs.
D. Approx. 60volts 2 Minutes Cured for at
least 6 hrs.
E. Approx. 70volts 2 Minutes Cured for at
least 6 hrs.
F. Approx. 50volts 2 Minutes Cured for at
least 6 hrs.
1 FIG. 2 shows a schematic for a device 20 which will
generate pulses usable with the method. Device 20 outputs square
waves with a frequency of 11 pulses per second (the frequency may
be adjusted by potentiometer R18), pulse width of 40 microseconds
(the pulse width may be adjusted by potentiometer R19), and an
amplitude from 0 to 200 volts (the amplitude is adjusted by po-
tentiometer R4). The various circuit elements of FIG. 2 are as
follows (resistance in ohms and capacitance in microfarads):
IC-l Multivibrator MC 3380P
IC-2 Timer NE 556
Ql Transistor MJE-3300
Q2 Transistor 2N 3391
Q3 Transistor MJE-13005
Tl Transformer 20 turn primary, 200 turn
secondary
Rl Resistor lO0
R2 Resistor lK
R3 Resistor 22K
R4 Potentiometer lM
R5 Resistor 27K
R6 Resistor lOK
R7 Resistor 120K
R8 Resistor lK
R9 Resistor 100
R10 Resistor lK
R11 Resistor 22K
R12 Resistor 100
R14 Resistor 680
R18 Potentiometer 50K
R19 Potentiometer lOOK
R20 Resistor lK
R21 Resistor 270K
Cl Capacitor 100, 6V
C2 Capacitor 500, 25V
C4 Capacitor 2.2
C5 Capacitor .047
C6 Capacitor 2.2, 250V
C7 Capacitor .01
C8 Capacitor .47, lOOV
C9 Capacitor 2.2, 25V
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1 Cll Capacitor 4.7, 250V
C12 Capacitor .1, 250V
C13 Capacitor .02
C14 Capacitor .01
C15 Capacitor lOOpf
Having described one specific preferred embodiment of
the invention, I claim:
