Patent No. 5501704 Method for applying low energy emission therapy

 

Patent No. 5501704

Method for applying low energy emission therapy (Chang, et al., Mar 26, 1996)

Abstract

A low energy emission therapy system is provided which includes an emitter of low energy electromagnetic emissions and a probe for applying the emissions to a patient under treatment. The emitter emits a high frequency electromagnetic emission in the form of a carrier signal modulated by a plurality of modulation signals. The invention also includes an impedance transformer located intermediate the emitter and the probe in order to match the impedance of the patient with that of the output of the emitter. Particular modulation signal frequencies and application times and sequences are provided for the treatment of insomnia, and for the treatment of general anxiety disorder which may include panic attacks.

Notes:

BACKGROUND OF THE INVENTION

The invention relates to systems and methods for applying low energy emission therapy for the treatment of central nervous system disorders.

Low energy emission therapy involving application of low energy electromagnetic emissions to a patient has been found to be an effective mode of treating a patient suffering from central nervous system (CNS) disorders such as generalized anxiety disorders, panic disorders, sleep disorders including insomnia, circadian rhythm disorders such as delayed sleep, psychiatric disorders such as depression, obsessive compulsive disorders, disorders resulting from substance abuse, sociopathy, post traumatic stress disorders or other disorders of the central nervous system. Apparatus and methods for carrying out such treatment are described in U.S. Pat. Nos. 4,649,935 and 4,765,322, assigned to the same assignee as the present application, the disclosures of which are expressly incorporated herein by reference. Since the time of these earlier disclosures, a substantially greater understanding of the mechanisms of the treatment and how to secure best results has been gained, which has led to important developments being made to the apparatus (herein described as a system).

Although the apparatus and methods described in the above patents have provided satisfactory results in many cases, consistency and significance of results has sometimes been lacking. Also, it was not always possible to properly control or monitor the duration of treatment or the quantities or nature of the low energy emissions being applied to the patient. Furthermore, the efficiency of transfer of the low energy emissions to the patient was limited and was affected by such factors as patient movement, outside interference and the like.

Another limitation of the previously described apparatus is that it is not very amenable to ready marketing by marketing organizations specifically of the nature comprised in the pharmaceutical industry. The apparatus is intended for therapy or treatment of patients and the low energy emissions applied to the patient are akin to pharmaceutical medication. The marketing organization of a pharmaceutical industry should thus be placed in a position to market the therapy in a fashion not widely different from the fashion in which pharmaceutical products are marketed, e.g., through pharmacists, with or without a doctor's prescription.

Research on treatment for insomnia has lagged behind other medical research programs. Current treatment methods for insomnia consist either of hypnotics, behavioral therapies (e.g. biofeedback), or of the use of drug agents, specifically benzodiazepines or imidazopyridines. Tolerance, dependence, memory loss, and lac of efficacy in long-term treatment are among the most common drawbacks of these classes of currently available hypnotics.

Research throughout the past two decades has shown clearly that the brain serves not only as a communication link and thought-processing organ, but also as the source of significant chemical activity, as well as a number of bioactive compounds. Many of these neurotransmitter compounds and ions are secreted following chemical or electrical stimuli. Research has also shown that some of these neuroactive compounds are involved in the regulation of sleep and wake cycles (Koella, "The Organization and Regulation of Sleep," Experientia, 1984; 40(4): 309-408).

During the 1970s, Adey and his group demonstrated that weak electromagnetic fields, modulated at certain well-defined low frequencies, were able to modify the release of ions (calcium) and neurotransmitters (GABA) in the brain (Kaczmarek and Adey, "The Eflux of .sup.45 Ca.sup.2+ and [.sup.3 H]y-aminobutyric Acid from Cat Cerebral Cortex," Brain Research, 1973; 63:331-342; Kaczmarek and Adey, "Weak Electronic Gradients Change Ionic and Transmitter Fluxes in Cortex," Brain Research, 1974; 66:537-540; Bawin et al., "Ionic Factors in Release of .sup.45 Ca.sup.2+ From Chicken Cerebral Tissue by Electromagnetic Fields," Proceedings of the National Academy of Science, 1978; 75(12):6314-6318). In these experiments the cortex of anaesthetized cats was initially incubated with radio-labeled calcium and radio-labeled GABA. When the cortex was exposed to continuous stimulation by weak electric fields modulated at 200 Hz, the researchers found a 1.29-fold increase in Ca++ and a 1.21-fold increase in GABA release (Kaczmarek and Adey, Brain Research, 1973; 63:331-342). Interestingly, the release of GABA happened in parallel with the release of Ca++, suggesting that the two phenomena are closely linked. The findings of increased Ca++ release from brain tissue upon stimulation with modulated electromagnetic fields have been replicated (Dutta et al., "Microwave Radiation Induced Calcium Ions Effused from Human Neuroblastoma Cells in Culture," Bioelectromagnetics, 1984; 5(1):71-78; and Blackman et al., "Influence of Electromagnetic Fields on the Efflux of Calcium Ions from Brain Tissue in Vitro," Bioelectromagnetics, 1988; 9:215-227). It now has become an established fact that weak electric fields modulated at certain low frequencies are able to modulate the release of Ca++and GABA.

During 1983, it was discovered that weak electromagnetic fields, modulated at low frequencies and delivered by means of an antenna placed in the buccal cavity, caused changes in EEG readings in human volunteers. In agreement with the findings of Adey and Blackman, it was found that only certain well-defined low frequency modulations of a standard carrier frequency (27 MHz), emitted with a well-defined intensity, were capable of eliciting EEG changes.

SUMMARY OF THE INVENTION

The present invention has rendered feasible an entirely new approach to treatment of a patient described in our said earlier patents while avoiding the above-noted drawbacks.

The present invention contemplates provision in the system (apparatus) of an interface for an application storage device, which application storage device can comprise storage media, such as, magnetic storage media, semiconductor memory storage media, optical memory storage media, or mechanical storage media. The selected storage media is programmed to carry various control information. Other information which may be stored in the storage media includes duration control information which would control the duration of the low energy electromagnetic emission and hence the duration of the application of the emission to the patient. Further control information can include duty cycle control information which would control the emissions, for example, in such a fashion that the low energy emission is alternately discontinued and re-initiated for chosen periods of time. Yet further control information which may be programmed into the storage media includes selecting information which would select emissions of various different modulation waveforms and frequencies which emissions can be emitted sequentially, with or without pauses between the emissions. Still further control information that may be programmed into the storage media includes power level control information.

In one embodiment of the invention, the system includes a microprocessor into which is loaded control information from the application storage device. The microprocessor then controls the function of the system to produce the desired therapeutic emission.

Another embodiment of the present invention contemplates that the application storage device would be combined into a single unit, and would be connected to the system through an interface in order to control the system.

In either of these embodiments, the present invention contemplates that the interface may include a communications channel such as, for example, a radio frequency link or telephone line, which connects the application storage device to the rest of the system.

The present invention also contemplates provision in the system of an impedance transformer connected intermediate the emitter of low energy electromagnetic emissions and a probe for applying the emissions to the patient, which impedance transformer substantially matches the impedance of the patient seen from the emitter circuit with the impedance of the output the emitter circuit.

Another aspect of the present invention is the provision of a power reflectance detector which detects an amount of power applied to a patient and compares that amount to an amount of power emitted by the system. The power detector permits the monitoring of patient compliance with the prescribed treatment. Such patient treatment compliance information may be stored on the application storage device for later retrieval and analysis. For example, the power detector may be used to detect the number of treatments applied to a particular patient, and the elapsed time for each treatment. Further, the actual time of day of each treatment may also be recorded, as may the number of attempted treatments.

These and other features and advantages of the present invention will become apparent to those of skill in this art with reference to the appended drawings and following details description.

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DISCUSSION:

The results are noteworthy for several reasons. First, LEET is an entirely new treatment paradigm which offers an attractive side effect profile and the potential to treat anxiety and related disorders. Second, the results are encouraging both in the magnitude of the effect and in the percentage of patients who achieved a clinically significant improvement. Third, the possibility that all instances of observed efficacy are due to placebo response is diminished by the duration of the observed improvement and that several of the patients had failed to improve in prior controlled studies and in previous open treatment with high potency benzodiazepines and/or antidepressants. Further research under double-blind conditions is indicated to further establish the efficacy of LEET and to clarify its role in clinical practice.

Although the invention has been described with reference to certain embodiments, it will be understood by those of skill in this art that additions, deletions and changes can be made to these embodiments, without departing from the spirit and scope of the present invention.