APPARATUS AND METHOD FOR TREATMENT OF MENTAL AND BEHAVIORAL CONDITIONS AND DISORDERS WITH ELECTROMAGNETIC FIELDS

Abstract

An apparatus for treating a behavioral condition of an animal, including a loop coil; a signal generator coupled to the loop coil, the signal generator being configured to transmit a treatment signal through the loop coil; and a harness connected to one or more of the loop coil and the signal generator, the harness including one or more fasteners each configured to fasten to one or more of a neck and a forelimb joint of the animal to position the loop coil proximate a head of the animal, the treatment signal including a plurality of bursts having a peak amplitude of less than about 200 milliGauss, the plurality of bursts having an average duration of between about 0.5 msec and about 50 msec, and the plurality of bursts being repeated at between 0.01 and 100 Hz.

Claims

1. An apparatus for treating a behavioral condition of an animal, said apparatus comprising: a loop coil; a signal generator coupled to the loop coil, the signal generator being configured to transmit a treatment signal through the loop coil; and a harness connected to one or more of the loop coil and the signal generator, the harness comprising one or more fasteners each configured to fasten to one or more of a neck and a forelimb joint of the animal to position the loop coil proximate a head of the animal, wherein the treatment signal comprises a plurality of bursts having a peak amplitude of less than about 200 milliGauss, wherein the plurality of bursts have an average duration of between about 0.5 msec and about 50 msec, and wherein the plurality of bursts are repeated at between 0.01 and 100 Hz.

2. The apparatus of claim 1, wherein the plurality of bursts comprise sinusoidal waves of between 15-40 MHz.

3. The apparatus of claim 2, wherein the sinusoidal waves have a 27.12 MHz carrier frequency.

4. The apparatus of claim 1, wherein a center of the loop coil is placed over a base of a skull of the animal when the harness is fastened to the animal.

5. The apparatus of claim 1, wherein the treatment signal is emitted as a pulsed electromagnetic field through the loop coil.

6. The apparatus of claim 1, wherein the plurality of bursts are repeated at approximately 7 Hz.

7. The apparatus of claim 1, wherein the average duration of the plurality of bursts is approximately 2 ms.

8. The apparatus of claim 1, wherein the peak amplitude is approximately 0.05 Gauss.

9. A method for treating a behavioral condition of an animal, comprising: positioning a flexible coil wire applicator of a lightweight wearable or stationary pulsed EMF therapy device adjacent to a head of an animal to be treated; and applying a treatment regime from the therapy device, wherein the treatment regime comprises a plurality of bursts of an electromagnetic signal having a peak amplitude of less than about 200 milliGauss, wherein the plurality of bursts have an average duration of between about 0.5 msec and about 50 msec, and wherein the plurality of bursts are repeated at between 0.01 and 100 Hz.

10. The method of claim 9, wherein the plurality of bursts comprise sinusoidal waves of between 15-40 MHz.

11. The method of claim 10, wherein the sinusoidal waves have a 27.12 MHz carrier frequency.

12. The method of claim 9, wherein the treatment regime has a treatment on-time of between about 5 minutes and 30 minutes, followed by a treatment off-time that is greater than about 30 minutes.

13. The method of claim 12, wherein the treatment on-time is 15 minutes.

14. The method of claim 12, wherein the treatment off-time is about 8 to 16 hours.

15. The method of claim 9, wherein the positioning comprises placing a center of the coil wire applicator over a base of a skull of the animal.

16. The method of claim 9, wherein the plurality of bursts are repeated at approximately 7 Hz.

17. The method of claim 9, wherein the average duration of the plurality of bursts is approximately 2 ms.

18. The method of claim 9, wherein the peak amplitude is approximately 0.05 Gauss.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0044] Preferred embodiments of the present invention will be described below in more detail, with reference to the accompanying drawings:

[0045] FIG. 1 is a block diagram of miniaturized circuitry according to a preferred embodiment of the present invention;

[0046] FIG. 2 depicts a drawing of a portable generator and coil according to a preferred embodiment of the present invention; and,

[0047] FIG. 3 illustrates a preferred embodiment according to the present invention of an apparatus incorporating a harness for positioning the generator and applicator coil.

DETAILED DESCRIPTION OF THE INVENTION

[0048] Induced time-varying currents from PEMF or PRF devices flow in a target pathway structure, such as a molecule, cell, tissue, and organ, and it is these currents that are a stimulus to which cells and tissues can react to in a physiologically meaningful manner. It has been established that mental and behavioral conditions and disorders in humans and animals have underlying physiological, cellular, and biochemical components. The electrical properties of a target pathway structure affect levels and distributions of induced current. Molecules, cells, tissue, and organs are all in an induced current pathway, such as cells in a gap junction contact. Ion or ligand interactions at binding sites on macromolecules that may reside on a membrane surface are voltage dependent processes, that is electrochemical, that can respond to an induced electromagnetic field (“E”). Induced current arrives at these sites via a surrounding ionic medium. The presence of cells in a current pathway causes an induced current (“J”) to decay more rapidly with time (“J(t)”). This is due to an added electrical impedance of cells from membrane capacitance and time constants of binding and other voltage sensitive membrane processes, such as membrane transport.

[0049] Equivalent electrical circuit models representing various membrane and charged interface configurations have been derived. For example, in Calcium (“Ca.sup.2+”) binding, the change in concentration of bound Ca.sup.2+ at a binding site due to induced E may be described in a frequency domain by an impedance expression such as:

[00001]$Z_b\left(\omega \right)=R_{\mathrm{ion}}+\frac{1}{i\omega C_{\mathrm{ion}}}$

which has the form of a series resistance-capacitance electrical equivalent circuit. Where co is angular frequency (=2πf, where f is frequency), i=−1.sup.1/2 Zb(ω) is the binding impedance and R.sub.ion and C.sub.ion are equivalent binding resistance and capacitance of an ion binding pathway. The value of the equivalent binding time constant, τ.sub.ion=R.sub.ionC.sub.ion, is related to an ion binding rate constant, k.sub.b, via τ.sub.ion=R.sub.ionC.sub.ion=1/k.sub.b. Thus, the characteristic time constant of this pathway is determined by ion binding kinetics.

[0050] Induced E from a PEMF signal can cause current to flow into an ion binding pathway and affect the number of Ca.sup.2+ ions bound per unit time. An electrical equivalent of this is a change in voltage across the equivalent binding capacitance C.sub.ion, which is a direct measure of the change in electrical charge stored by C.sub.ion. Electrical charge is directly proportional to the surface concentration of Ca' ions in the binding site, that is storage of charge is equivalent to storage of ions or other charged species on cell surfaces and junctions. Electrical impedance measurements, as well as direct kinetic analyses of binding rate constants, provide values for time constants necessary for configuration of a PEMF waveform to match a bandpass of target pathway structures. This allows for a required range of frequencies for any given induced E waveform for optimal coupling to target impedance, such as bandpass.

[0051] Ca.sup.2+ binding to calmodulin (“CaM”) is a frequent EMF target. Use of this pathway is based upon reports that acceleration of wound repair and for example bone repair, involves modulation of growth factors released in various stages of repair. Growth factors such as platelet derived growth factor (“PDGF”), fibroblast growth factor (“FGF”), and epidermal growth factor (“EGF”) are all involved at an appropriate stage of healing. Angiogenesis is also integral to wound repair and modulated by PMF. All of these factors are Ca/CaM-dependent.

[0052] Utilizing a Ca/CaM pathway a waveform can be configured for which induced power is sufficiently above background thermal noise power. Under correct physiological conditions, this waveform can have a physiologically significant bioeffect.

[0053] Application of a Power SNR model to Ca/CaM requires knowledge of electrical equivalents of Ca.sup.2+ binding kinetics at CaM. Within first order binding kinetics, changes in concentration of bound Ca.sup.2+ at CaM binding sites over time may be characterized in a frequency domain by an equivalent binding time constant, τ.sub.ionR.sub.ionC.sub.ion, where R.sub.ion and C.sub.ion are equivalent binding resistance and capacitance of the ion binding pathway. τ.sub.ion is related to a ion binding rate constant, k.sub.b, viaτT.sub.ion=R.sub.ionC.sub.ion=1/kb. Published values for k.sub.b may then be employed in a cell array model to evaluate SNR by comparing voltage induced by a PRF signal to thermal fluctuations in voltage at a CaM binding site. Employing numerical values for PMF response, such as Vmax=6.5×10-7 sec 1, [Ca.sup.2+]=2.5 μM, KD=30 μM, [Ca.sup.2+CaM]=KD([Ca.sup.2+]+[CaM]), yields k.sub.b=665 sec−1 (τ.sub.ion=1.5 msec). This value for τ.sub.ion can be employed in an electrical equivalent circuit for ion binding while power SNR analysis may be performed for any waveform structure. In a preferred embodiment of the present invention a PEMF signal of 27.12 MHz with a pulse duration of 2 msec at 7Hz is applied to the treatment area to effectuate the treatment of mental and behavioral conditions and disorders, in particular anxiety.

[0054] FIG. 1 depicts a block diagram of a miniature control circuit (hereinafter “portable generator,” “waveform generator,” or “generator) 100 for generating a signal to be transmitted as a PEMF treatment signal through an applicator coil to a treatment target according to an exemplary embodiment of the present invention. The miniature control circuit 100 produces waveforms that are driven through a transmitting device, such as one or more wire coils (hereinafter “applicator coil(s),” “loop(s),” “coil(s)”) , for transmission to a treatment target, as will be described in further detail below. The miniature control circuit 100 has a self-contained energy source 105, which may be a replaceable or rechargeable battery. A preferred embodiment of the self-contained energy source 105 has an output voltage of 3.3 V but other voltages can be used. A switching power supply 110 controls voltage to a microcontroller 115. A preferred embodiment of the microcontroller 115 is an 8-bit 4 MHz microcontroller but other bit MHz combination micro-controllers may be used. The switching power supply 110 also delivers current to a main energy storage 120, which may be embodied by one or more storage capacitors. A preferred embodiment of the present invention uses storage capacitors having a 220 μF output but other outputs can be used. The storage capacitors of main energy storage 120 allow high frequency pulses to be delivered to a coupling device, such as inductors. The microcontroller 115 also controls a pulse shaper 125 and a pulse phase timing control 130. The pulse shaper 125 and pulse phase timing control 130 determine pulse shape, burst width, burst envelope shape, and burst repetition rate of an output signal. A voltage level conversion sub-circuit 135 controls an induced field delivered to a target pathway structure. A switching Hexfet 140 allows pulses of pseudo-randomized amplitudes to be delivered to an output 145 that routes a waveform to at least one delivery device, such as an inductor. The microcontroller 115 can also control total exposure time of a single treatment of a target pathway structure, such as a molecule, cell, tissue, and organ. A preferred embodiment according to the present invention uses treatments times of about 1 minute to about 30 minutes.

[0055] According to an exemplary embodiment of the invention, generator circuit 100 is configurable by Signal to Noise Ratio (“SNR”) and Power Signal to Noise Ratio (“Power SNR”) approaches to configure bioeffective waveforms.

[0056] Specifically, broad spectral density bursts of electromagnetic waveforms, configured to achieve maximum signal power within the bandpass of a biological target, are selectively applied to target pathway structures, such as living organs, tissues, cells and molecules. Waveforms are selected using a unique amplitude/power comparison with that of thermal noise in a target pathway structure. Signals comprise bursts of sinusoidal, rectangular, or pseudo-random wave shapes; have frequency content in a range of about 0.01 Hz to about 100 MHz at about 1 to about 100,000 wave shapes per second; and with a burst duration from about 0.01 to about 100 milliseconds; and a repetition rate from about 0.01 to about 1,000 bursts/second. Peak signal amplitude at a target pathway structure such as tissue, lies in a range of about 1μV/cm to about 100 mV/cm. Each signal burst envelope may be a pseudo-random function providing a means to accommodate different electromagnetic characteristics of healing tissue. These waveforms may be delivered via inductive or capacitive coupling for 1 to 30-minute treatment sessions delivered according to predefined regimens by which PEMF treatment may be applied for 1 to 12 daily sessions, repeated daily. The treatment regimens for any waveform configured according to the instant invention may be fully automated or applied manually. The number of daily treatments may be programmed to vary on a daily basis according to any predefined protocol.

[0057] FIG. 2 depicts a drawing of a portable generator 100 and an applicator coil 205 according to an exemplary embodiment of the present invention. The applicator coil 205, comprising one or more turns of electrically-conductive wire in a generally circular or oval shape, is connected to a waveform generator 100 having circuitry generally configured as described above with reference to FIG. 1. The coil 205 can have circular dimensions ranging from about 2 inches in diameter to about 30 inches in diameter. The coil 205 may be conformed to a particular anatomical location, for example the head area of a human or animal. In a preferred embodiment of the present invention, there are two coil diameters of 5 inches and 7 inches used in accordance with the subject's head size.

[0058] FIG. 3 illustrates a wearable assembly 300 incorporating portable generator 100 and applicator coil 205 for applying treatment to an animal according to an exemplary embodiment of the present invention. A supporting device 305, such as a harness, is worn to position the applicator coil 205 above the head of a human or animal. The harness 305 may be made of cotton, nylon, elastic or any other anatomical wrap or support material. The applicator coil 205 is positioned on the harness 305 such that the PEMF signal of the present invention is applied to the entire volume of the head for the treatment of mental or behavioral conditions or disorders, which result from neurological inflammatory processes or other contributing biophysiological, biochemical or neural factors. The PEMF Generator 100 is held in place on the support garment 305 using a fastening device, such as hook and loop, within a special pocket or by some other attachment so as to ease removal of the PEMF Generator 100 from the harness 305 by the user for cleaning, storage, replacement and other needs. The PEMF Generator 100 is coupled to the coil 205 by at least one connecting device, such as a flexible wire, or by emanating directly out of the enclosure of the generator 100—for example, as illustrated in FIG. 2.

EXAMPLE 1

[0059] A preliminary study on pet animals was conducted on the efficacy of electromagnetic treatment on separation anxiety (SA) in pet dogs according to an exemplary embodiment of the invention. In particular, a number of pet dogs were subjected to daily treatments using a PEMF treatment apparatus conforming to wearable assembly 300 described above for a period of 42 days.

[0060] Separation anxiety (SA), problematic behavior associated with anxiety that occurs exclusively in the owners' absence or perceived absence, is an important clinical issue in dogs affecting both their quality of life and their bond with their owners. Separation anxiety is a leading reason for owners abandoning their dogs, surrendering them to shelters or even euthanizing them. The condition is widespread, affecting an estimated 14% to 17% of households with dogs. Veterinarians rank it as the second most common behavioral disorder in dogs and in one recent VIN survey, 33% of respondent veterinarians reported that SA exists in over a quarter of their case load. While behavior modification and medications are used in combination to treat the majority of cases, treatment is often incomplete and unsatisfactory. Therefore, a significant unmet need exists for additional and effective treatment alternatives.

[0061] In particular, a treatment signal was selected in order to invoke anxiolytic effects and to inhibit proinflammatory cytokines or their signaling pathways. Corresponding to the description above, the strength of the treatment signal was selected so as to be sufficient to affect nervous system activity and cellular metabolism and signaling, but below the threshold required to directly induce action potentials. Finally, the subthreshold PEMF signal was selected to confirm positive effects of direct cranial stimulation with an induced electric field on cognitive disorders, such as depression, via changes in brain wave activity, including increase in theta wave activity associated with relaxation and anxiolytic responses.

[0062] The test subjects were selected in accordance with the following criteria: [0063] a. Dogs must be between 1-13 years of age, inclusive; [0064] b. Dogs must be generally healthy; [0065] c. Dogs must have a diagnosis of SA (from a veterinarian or behaviorist) for at least three months prior to enrollment;

[0066] Additionally, the subjects were selected according to the following criteria with respect to their owners: [0067] a. Owners must typically leave the dog alone upon their departure in an area where a 130 degree view video-camera can monitor their activity. This can be a large room, a section of a room, a crate or other confined space. [0068] b. Owner must provide a stable home environment for the duration of the study (9 weeks, including one week of baseline data collection, 6 weeks of treatment and 2 weeks of treatment withdrawal). A stable environment is defined as no major changes in the household routine (such as a single vacation of longer than 3 days; no more than 2 weekends away; no extended stay visitors; no arrival of new family members, including new pets, etc.).

[0069] Finally, potential subjects with one or more of the following conditions were excluded from the study: [0070] a. Dogs that are less than 1 year of age or older than 13 years of age [0071] b. Female dogs that are pregnant or lactating [0072] c. Dogs that have been recently diagnosed with SA (within the past 3 months) [0073] d. Dogs with a concomitant diagnosis of thunderstorm or noise phobia [0074] e. Dogs currently receiving psychoactive or sedating medication and whose dose has not been stable for the past month, at a minimum [0075] f. Dogs receiving more than one psychoactive or sedating medication, including episodic medications [0076] g. Dogs with concomitant conditions that are determined by the primary veterinarian or study investigator to potentially impact the study results

[0077] A 7-day control period preceded a treatment period of 6 weeks (42 days) for 10 pet dogs, followed by a 2 week (14 days) treatment withdrawal period. Treatment progress was recorded for each animal at Day 7, Day 14, Day 28, Day 42, and Day 56, in the form of owner questionnaires and video recordings of the dogs when left home alone.

[0078] At the outset of the 7-day control (baseline) period, owners of the subjects were provided with a questionnaire to record an initial state of the test subjects:

TABLE-US-00001 TABLE 1 Separation Anxiety Symptom Severity Score 0 = 1 = 2 = 3 = Separation related behavior absent mild moderate severe Destructive behavior (chewing, breaking, tearing, etc.) includes crate Rearranging behavior (without destruction) Excessive Vocalization Inappropriate Urination Inappropriate Defecation Overall (Global) separation related anxiety

[0079] Table 1 above lists SA behaviors that were determined and noted by owners based on an owner leaving the pet animal for a prolonged period of at least 60 minutes, according to their established routine. Owners were asked to rate their dog's severity within each behavior listed as well as rate the dog's overall severity (global score), at baseline (Day −7 and Day 0) and periodically throughout the study (Day 7, 14, 28, 42 and 56). In addition to these owner assessments, dogs were recorded by video for 60 minutes in these sessions when the owner left the dog home alone. These videos were analyzed and the duration (percentage of time during the 60 minutes when the dog was engaged in the behavior) or for some behaviors the frequency (number of occurrences during the 60 minute video recording) of selected behaviors were noted and scored by the video analyzer. The behaviors that were analyzed in the videos included panting (PT); whining/howling (WH); urination; defecation; destruction (DE); rearranging (RA); orientation to the environment (OE); restlessness/pacing (RP); yawning; barking; and resting or passive behaviors (PA). The control period baseline was calculated for each dog on Day 0 as the percentage of time spent in the behavior during the first 60 minutes of video recording after the dog was left alone. For some behaviors, the number of occurrences of the behavior was counted instead of the duration. These included yawning, urination, defecation and barking.

[0080] Owner Questionnaires

[0081] For owner questionnaires, the respective negative behaviors were noted by the owners upon returning from the above-described separation periods of at least 60 minutes. The baseline was calculated as the scores provided by the owners on Day 0. Table 2 below shows recorded behavioral scores for 9 of the test animals on Day −7 and Day 0—i.e., the control period preceding treatment:

TABLE-US-00002 TABLE 2 Day 0 Day-7 0 1 2 3 Total 0 0 0 0 0 0 1 0 1 2 0 3 2 0 0 3 0 3 3 0 0 0 3 3 Total 0 1 5 3 9

[0082] As shown above, a subset of the 9 subjects exhibited an increase in behavioral issues during the control period—i.e., from day −7 to day 0 of the treatment testing period. In particular, two subjects moved from a score of 1 on Day −7 to a score of 2 on Day 0. The other subjects exhibited no changes in behavior over the same control period. In other words, none of the subjects showed any improvement in behavior over the control period. In addition to the above five (5) behavior-specific scores and one (1) overall score, each subject was also associated with up to 3 unique behaviors (CSOM).

[0083] Starting from Day 0, each subject was given two 15-minute treatments each day, spaced 8-10 hours apart, using an apparatus conforming to wearable assembly 300 described above and illustrated in FIG. 3. The center of coil 205 was placed over the base of each dog's skull, with the coil 205 either resting on the dog's skin or held slightly above it. The treatments were given at approximately the same time each day and well before planned times that the subjects' owners were to leave their homes (i.e., while the dog was still calm and not exhibiting anxiety related to anticipation of an owner's departure) For this example, the signal generator 100 was configured to produce a 7 Hz signal burst with a 27.12 MHz carrier frequency, the bursts being 2 ms in duration with a peak amplitude of 0.05 Gauss.

[0084] A positive response to treatment was seen as early as Day 7. As reflected in Table 3 below, from Day 0 to Day 7, five of the ten patients saw a reduction of at least one point in their overall scores. One of those patients saw a reduction of two points in their overall score (moving from a 2 to a 0). Four saw no change.

TABLE-US-00003 TABLE 3 Day 7 Day 0 0 1 2 3 Total 0 0 0 0 0 0 1 0 1 0 0 1 2 1 2 2 0 5 3 0 0 2 1 3 Total 1 3 4 1 9

[0085] As reflected in Table 4 below, from Day 0 to Day 14, six of the nine patients saw a reduction of at least one point in their overall scores. One of those patients saw a reduction of two points in their overall score (moving from a 2 to a 0). Three patients saw no change.

TABLE-US-00004 TABLE 4 Day 14 Day 0 0 1 2 3 Total 0 0 0 0 0 0 1 0 1 0 0 1 2 1 2 2 0 5 3 0 0 3 0 3 Total 1 3 5 0 9

[0086] As reflected in Table 5 below, from Day 0 to Day 28, nine of the nine patients saw a reduction of at least one point in their overall scores. One of those patients saw a two-point reduction (from 3 to 1). The patient that saw a reduction from 2 to 0 earlier was back at a 1 this week.

TABLE-US-00005 TABLE 5 Day 28 Day 0 0 1 2 3 Total 0 0 0 0 0 0 1 1 0 0 0 1 2 0 5 0 0 5 3 0 1 2 0 3 Total 1 6 2 0 9

[0087] As reflected in Table 6 below, from Day 0 to Day 42, nine of the nine patients saw at least a one-point reduction in their overall scores. Five of the nine patients saw a reduction to zero from their initial scores (one from one, three from two, and one from three). Five of the nine patients saw at least a two-point reduction.

TABLE-US-00006 TABLE 6 Day 42 Day 0 0 1 2 3 Total 0 0 0 0 0 0 1 1 0 0 0 1 2 3 2 0 0 5 3 1 1 1 0 3 Total 5 3 1 0 9

[0088] As reflected in Table 7 below, from Day 0 to Day 56, three of the nine dogs were back at a score of two. Six remain in lower score categories on Day 56 when compared to Day 0.

TABLE-US-00007 TABLE 7 Day 56 Day 0 0 1 2 3 Total 0 0 0 0 0 0 1 1 0 0 0 1 2 2 0 3 0 5 3 1 1 1 0 3 Total 4 1 1 0 9

[0089] In other words, three of the subjects showed some regression approximately two weeks after treatments were stopped.

[0090] Table 8 below lists, for each progress record date, a percentage (%) of success (1 point reduction overall) and a confidence interval for the recorded success (wald score interval if 100%)

TABLE-US-00008 TABLE 8 Number Proportion 95% Confidence Days of Dogs of Successes Interval 0 to 7  9 0.56 (0.21, 0.86) 0 to 14 9 0.67 (0.29, 0.93) 0 to 28 9 1.00 (0.66, 1.00) 0 to 42 9 1.00 (0.66, 1.00) 0 to 56 9 0.67 (0.29, 0.93)

[0091] Table 9 below lists, for each progress record date, a percentage (%) complete resolution of all behavioral issues (reach 0) by Day 56, side by side with success rate shown in Table 8.

TABLE-US-00009 TABLE 9 95% 95% Number Proportion Confidence Proportion Confidence of Dogs of Successes Interval Resolved Interval 0 to 7  9 0.56 (0.21, 0.86) 0.11 (0.00, 0.48) 0 to 14 9 0.67 (0.29, 0.93) 0.11 (0.00, 0.48) 0 to 28 9 1.00 (0.66, 1.00) 0.11 (0.00, 0.48) 0 to 42 9 1.00 (0.66, 1.00) 0.56 (0.21, 0.86) 0 to 56 9 0.67 (0.29, 0.93) 0.44 (0.13, 0.79)

[0092] Correspondingly, the percentages of success and percentages of complete resolution were recorded for each of the five (5) tested common behaviors, as listed in Table 1 above. It was noted that some of the high instances of resolved behaviors were because some of the subjects started at a zero in those specific behaviors.

[0093] Inappropriate Defecation: All nine dogs in the study started at zero and remained at zero for inappropriate defecation.

[0094] Destructive Behavior: Table 10 below lists the results for destructive behavior and Table 11 lists the results for a subset of the subjects that showed a non-zero score for this behavior at Day 0.

TABLE-US-00010 TABLE 10 Behavior: Destruct (Note: Five of the nine dogs started at zero for the resolved proportions) Number Proportion 95% Confidence Number Proportion 95% Confidence Days of Dogs of Successes Interval of Dogs Resolved Interval 0 to 7  9 0.11 (0.00, 0.48) 9 0.55 (0.21, 0.86) 0 to 14 9 0.11 (0.00, 0.48) 9 0.55 (0.21, 0.86) 0 to 28 9 0.33 (0.07, 0.70) 9 0.55 (0.21, 0.86) 0 to 42 9 0.44 (0.13, 0.79) 9 0.78 (0.39, 0.97) 0 to 56 9 0.44 (0.13, 0.79) 9 0.67 (0.29, 0.93)

TABLE-US-00011 TABLE 11 Behavior: Destruct (Only for the non-zero dogs) 95% 95% Proportion Confidence Proportion Confidence Days N of Successes Interval N Resolved Interval 0 to 7  4 0.25 (0.00, 0.81) 4 0.00 NA 0 to 14 4 0.25 (0.00, 0.81) 4 0.00 NA 0 to 28 4 0.75 (0.19, 0.99) 4 0.00 NA 0 to 42 4 1.00 (0.39, 1.00) 4 0.50 (0.06, 0.93) 0 to 56 4 1.00 (0.39, 1.00) 4 0.50 (0.06, 0.93)

[0095] Rearranging Behavior: Table 12 below lists the results for rearranging behavior and Table 13 lists the results for a subset of the subjects that showed a non-zero score for this behavior at Day 0.

TABLE-US-00012 TABLE 12 Behavior: Rearrange (Note: Five of the ten dogs started at zero) Number Proportion 95% Confidence Number Proportion 95% Confidence Days of Dogs of Successes Interval of Dogs Resolved Interval 0 to 7  9 0.11 (0.00, 0.48) 9 0.55 (0.21, 0.86) 0 to 14 9 0.22 (0.02, 0.60) 9 0.55 (0.21, 0.86) 0 to 28 9 0.44 (0.13, 0.79) 9 0.55 (0.21, 0.86) 0 to 42 9 0.44 (0.13, 0.79) 9 0.78 (0.39, 0.97) 0 to 56 9 0.22 (0.02, 0.60) 9 0.67 (0.29, 0.93)

TABLE-US-00013 TABLE 13 Behavior: Rearrange (Only for the non-zero dogs) Proportion 95% 95% of Confidence Proportion Confidence Days N Successes Interval N Resolved Interval 0 to 7  4 0.25 (0.00, 0.81) 4 0.00 NA 0 to 14 4 0.50 (0.06, 0.93) 4 0.00 NA 0 to 28 4 1.00 (0.39, 1.00) 4 0.00 NA 0 to 42 4 1.00 (0.39, 1.00) 4 0.50 (0.06, 0.93) 0 to 56 4 0.50 (0.06, 0.93) 4 0.25 (0.00, 0.81)

[0096] Inappropriate Urination: Eight of the nine dogs started at zero. The dog that did not start at zero started at a two and moved to a zero by Day 7, moved back to a two at Day 28, returned to zero at Day 42, and remained at zero through Day 56. Of the eight dogs that started at zero at Day 0, one moved to one at Day 56.

[0097] Excessive Vocalization: Table 14 below lists the results for excessive vocalization and Table 15 lists the results for a subset of the subjects that showed a non-zero score for this behavior at Day 0.

TABLE-US-00014 TABLE 14 Behavior: Vocalize (Note: Two of these dogs started at zero) Number Proportion 95% Confidence Number Proportion 95% Confidence Days of Dogs of Successes Interval of Dogs Resolved Interval 0 to 7  8 0.63 (0.24, 0.91) 8 0.25 (0.03, 0.65) 0 to 14 9 0.56 (0.21, 0.86) 9 0.22 (0.02, 0.60) 0 to 28 9 0.89 (0.51, 0.99) 9 0.22 (0.02, 0.60) 0 to 42 9 0.88 (0.51, 0.99) 9 0.67 (0.29, 0.93) 0 to 56 9 0.67 (0.29, 0.93) 9 0.44 (0.13, 0.79)

TABLE-US-00015 TABLE 15 Behavior: Vocalize (Only for the non-zero dogs) 95% 95% Proportion Confidence Proportion Confidence Days N of Successes Interval N Resolved Interval 0 to 7  7 0.71 (0.29, 0.96) 7 0.28 (0.03, 0.71) 0 to 14 8 0.63 (0.24, 0.91) 8 0.25 (0.03, 0.65) 0 to 28 8 1.00 (0.63, 1.00) 8 0.25 (0.03, 0.65) 0 to 42 8 1.00 (0.63, 1.00) 8 0.63 (0.24, 0.91) 0 to 56 8 0.75 (0.34, 0.97) 8 0.37 (0.08, 0.75)

[0098] In addition to the five (5) commonly-tested behaviors, again, each subject was associated with up to three (3) unique behaviors, which were recorded as CSOM scores for each progress record day (0, 7, 14, 28, 42, and 56). The same one-point difference from Day 0 standard was used to determine success. If the average was zero, the score was considered resolved.

TABLE-US-00016 TABLE 16 CSOM Number Proportion 95% Confidence Number Proportion 95% Confidence Days of Dogs of Successes Interval of Dogs Resolved Interval 0 to 7  8 0.25 (0.03, 0.65) 8 0.00 N/A 0 to 14 9 0.22 (0.02, 0.60) 9 0.00 N/A 0 to 28 9 0.67 (0.29, 0.93) 9 0.00 N/A 0 to 42 9 0.78 (0.39, 0.97) 9 0.22 (0.02, 0.60) 0 to 56 9 0.56 (0.21, 0.86) 9 0.33 (0.07, 0.70)

[0099] From Day 42 to Day 56, 56% (5/9) of the dogs maintained their improvement (95% CI: (0.21, 0.86)). The overall maintenance of improvement over this treatment withdrawal period, as well as those specific to particular SA behaviors, is summarized in Table 17 below.

TABLE-US-00017 TABLE 17 Proportion Maintained (no deterioration 95% Number from Day 42 to Confidence Behavior of Dogs Day 56) Interval Defecate 9 All zero at Day 0. N/A Destruct 9 0.89 (0.51, 0.99) Rearrange 9 0.78 (0.39, 0.97) Urinate 9 0.89 (0.51, 0.99) (9 were zero at Day 0) Vocalize 9 0.67 (0.29, 0.93) Overall 9 0.56 (0.21, 0.86) CSOM 9 0.56 (0.21, 0.86)

[0100] Video Recording

[0101] As described above, the subjects were recorded by video for 60 minutes when the owners left them home alone. These videos were analyzed and the duration (percentage of time during the 60 minutes when the dog was engaged in the behavior) or for some behaviors the frequency (number of occurrences during the 60 minute video recording) of selected behaviors were noted and scored by the video analyzer. The behaviors that were analyzed in the videos included panting (PT); whining/howling (WH); urination; defecation; destruction (DE); rearranging (RA); orientation to the environment (OE); restlessness/pacing (RP); yawning; barking; and resting or passive behaviors (PA). The control period baseline was calculated for each dog on Day 0 as the percentage of time spent in the behavior during the first 60 minutes of video recording after the dog was left alone. For some behaviors, the number of occurrences of the behavior was counted instead of the duration. These included yawning, urination, defecation and barking.

[0102] For negative behaviors (DE, RA, RP, OE, PT, WH), if the initial value (at Day 0) were zero, there could not have been any reduction. Accordingly, success indicators were set to zero for subjects that showed a null initial value. Otherwise, if the ratio of the final day (Day 28, 42, or 56) to the baseline day (Day 0 or −7) was less than 0.9, that behavior was considered an improvement and a success. If any behavior showed such a determined improvement, the dog was counted as an overall success.

[0103] Table 18 below lists the results related to the specific negative behaviors that were analyzed in the video recordings.

TABLE-US-00018 TABLE 18 # Day Day 28 Day 42 Day 56 Behavior Dogs 0 (% Δ) (% Δ) (% Δ) Behaviors Scored by Duration-Total for all dogs with the behavior DE 2 8 7.9 (−1.3%) 16.4 (+105%) 0.9 (−89%) RA 2 30.4 1.3 (−96%) 4.6 (−85%) 35.3 (+16%) RP 3 36.2 8.8 (−76%) 11.7 (−67%) 8.4 (−77%) OE 9 383.6 337.5 NA* NA* (−12%) PT 2 70.3 78.6 (+12%) 82 (+17%) 78.9 (+12%) Behaviors Scored by Frequency of Occurrence-Total for All dogs with the behavior WH 2 17.8 20.5 (+15%) 9.6 (−54%) 7.4 (−58%) Barking 4 1224 298 (−76%) 1152 (−6%) 36 (−97%) Yawning 0 0 Urination 0 0 Defecation 0 0 *Video results from two dogs was not useable on Day 42; and one was not useable on Day 56 (Note: a (−) change indicates improvement and a (+) change indicates worsening of the behavior

[0104] As reflected above in Table 18, some of the subjects showed significant improvements in DE, RP, WH, and barking at the end of the study (Day 56), while some of the subjects showed slight worsening in RA and PT.

[0105] Table 19 below lists the results of overall successes determined by analyzing the video recordings of the subjects.

TABLE-US-00019 TABLE 19 Reduction in any Number Percentage one negative of of Overall 95% Exact behavior Dogs Successes Confidence Interval Day 28 9   100% (66.37%, 100%) Day 42 7 85.71% (42.13%, 99.64%) Day 56 8 87.50% (47.35%, 99.68%)

[0106] For the positive behavior (PA), if the initial value (at Day 0) were zero, there could not have been any ratio of an increase—i.e., indeterminate degree of improvement for comparison purposes. One of the subjects had all PA values at zero so this success indicator was set to No for this subject. Otherwise, if the ratio of the final day (Day 28, 42, or 56) to the baseline day (Day 0 or −7) was greater than 1.1, there had been a greater than 10% improvement in positive behavior and was considered a success. Table 20 below lists the results of positive behavior improvements determined by analyzing the video recordings of the subjects.

TABLE-US-00020 TABLE 20 Increase in Number Percentage 95% Exact positive behavior of Dogs of Success Confidence Interval Day 28 9 33.33% (7.49%, 70.07%) Day 42 7 85.71% (42.13%, 99.64%) Day 56 8 57.50% (47.35%, 99.68%)

[0107] In addition to the above, analysis was also conducted on retention of success that was obtained by a subset of the subjects that showed improvement by Day 28. To retain success by Day 42, a dog had to show overall success (10% improvement in at least one behavior) by Day 28 and remain a success at Day 42. To retain success by Day 56, a dog had to show success (10% improvement in at least one behavior) by Day 42 and remain a success at Day 56. Table 21 below lists the results of this analysis.

TABLE-US-00021 TABLE 21 Retain Overall Number Percentage 95% Exact Success of Dogs of Success Confidence Interval Day 42 7 85.71% (42.13%, 99.64%) Day 56 6 83.33% (35.88%, 99.58%)

[0108] As reflected in Table 21 above, seven (7) of the subjects obtained overall success by Day 28 and of them six (6) retained success at Day 42. Correspondingly, of the six (6) that retained success at Day 42, five (5) retained success at Day 56.

[0109] In view of the above, the preliminary testing showed that the inventive treatment regime was effective in reducing behavior problems in pet animals over treatment periods as short as 7 days and the positive effects lasted as long as 56 days—i.e., at the end of the treatment withdrawal period of the study.

[0110] Having described embodiments for an apparatus and a method for delivering electromagnetic signals to human, and animal molecules, cells, tissue and organs for therapeutic purposes, and in particular for the treatment of mental and behavioral conditions and disorders, it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the invention disclosed which are within the scope and spirit of the invention as defined by the appended claims.