ELECTROMAGNETIC RADIATION THERAPY
Field of the Invention
This invention relates to an apparatus producing, and a method of therapy using, electromagnetic radiation for the treatment of neurological and psychiatric conditions. The invention may be used in connection with the cure or alleviation of symptoms associated with neurological and psychiatric conditions such as depression, stress, anxiety, cerebral oedema/trauma, sexual dysfunction, dementia and neurodeεenerative conditions such as Parkinson's disease.
Background of the Invention
Current medically accepted methods of treating neurological and psychiatric conditions involves the administration of pharmacologically active products typically taken orally which reaches the brain via the circulation. Such treatments have many side effects, not only centrally with sedation but adverse side effects on other organs/tissues such as the gastrointestinal tract and bone marrow have been documented.
The cerebrum, which is encased and protected by the skull, is part of the neurological system. The cerebrum is a highly complex and incompletely understood organ. Amongst its many functions, it deals with personality, emotion, mood, evaluation of sensory input and initiation of motor output. The cerebrum is associated with the spinal cord and cranial nerves these nerves being involved with the senses of hearing, balance, sight, smell and also provide sensory and motor function of the head and neck.
It is generally accepted that the brain and retina begins to naturally functionally decay after the age of 35 years, however since the brain and retina have, like other organs, significant redundant capacity, the individual is able to function normally until such
time as the redundant capacity is exhausted. This decay processis insidious and goes unnoticed and is often associated with poor fine-motor control starting in the 6th and 71 decades of life, hence evaluation of patients handwriting during assessment of cognitive function.
It has been known for several decades that the use of light can give a positive therapeutic effect in the treatment of a wide spectrum of typically topical diseases. In the 1960's the use of narrow wavelength light was investigated in in vivo/in vitro experiments. It was found that light of wavelength greater than 440nm did not work. Further investigations were carried out with light having a wavelength of from 300 to 350nm (UV light) but it was found that infection was exacerbated/promoted rather than ameliorated/eliminated. Some attempts have been made to treat individuals affected with the herpes virus by treatment with light of the wavelength 660nm, as described in US 5500009.
Additionally, it is known from the prior art to use a laser to produce coherent radiation and to focus it on the area to be treated. Nd YAG laser treatment at a fundamental wavelength of 1064 nm is associated with decreased pain, scarring and improved healing (US 5445146). Additionally it has been reported that diodes emitting light at the red wavelength, 940 ± 25 nm can be used to treat a range of essentially musculoskeletal ailments (US 5259380). However there is no indication that light of a wavelength above this would be of any therapeutic use. Moreover there has been no indication in the prior art that light would have any effect on bone and or cartilage beneath the skin.
It has now been surprisingly established that low intensity electromagnetic radiation of narrow bandwidth light, when applied to the skin overlying the skull penetrates the skull bone and has an unexpected therapeutic effect on the underlying brain tissue itself and is effective in the treatment of treating neurological and psychiatric conditions in addition to rejuvenating the individual. It is postulated that the way in which the electromagnetic radiation effects its action is by way of energy
transmission through cellular components/organelles and may involve an alteration in neuronal membranes.
A water molecule that has a range of electromagnetic radiation wavelengths passed through it will produce several transmission peaks. These transmission peaks are associated with the preferred therapeutic electromagnetic radiation wavelength range of the invention and thus implies a role for the water molecule in the general mechanism of action.
Statements of the Invention
According to a first aspect of the present invention there is provided an apparatus for electromagnetic radiation therapy comprising means for emitting electromagnetic radiation being a wavelength of from 980 and 1350 nm, a patient attachment means whereby said apparatus is securable to a patient with said electromagnetic radiation emitting means being positioned adjacent bone which surrounds tissue of the central nervous system and so that radiation emitted from the electromagnetic radiation emitting means is directed towards said tissue, said electromagnetic radiation emitting means being capable of producing a radiation intensity of at least 15 m Watts/cm2 and up to 10 Watts/cm2 at the skin covering said bone.
Reference herein to a skin covering bone surrounding the central nervous system is intended to include, without limitation, the skin surrounding the skull, frontal and temporal areas, occipito parietal junction and base of the skull overlying the brain stem, spinal column and peripheral nerves of a human or animal subject. It will be appreciated that the present invention provides an apparatus for treating any part of the neurological system which is covered by bone.
Preferably, the apparatus comprises a plurality of means for emitting electromagnetic radiation and more preferably each of said means is independently controllable.
Preferably, the apparatus is adapted so that it is worn on or about the individual's head. In one embodiment of the invention the apparatus the apparatus comprises a pair of means for emitting electromagnetic radiation attached to either end of a curved, resilient bridge member. Preferably, the bridge member is an elongate strip composed of a suitable material such as plastics. Thus, in this embodiment the apparatus is in the form of a headset with light emitting sources positioned at either end which can be appropriately positioned about the user's head. In use, the means for emitting electromagnetic radiation are appropriately aligned with an individual's temple regions. It will be understood that preferably, the headset may be worn over the top, or around the front or back of a user's skull.
In another embodiment of the invention the apparatus is in the form of a helmet in which the means for emitting electromagnetic radiation are placed on an inside surface of the helmet.
Preferably, the headset and helmet are provided with means for shielding a user's eyes. For example, with the headset the means for emitting electromagnetic radiation may be encased within housing units/compartments which are attached to either end of the bridge means. Alternatively, where the apparatus is a helmet, the helmet may be provided with an inwardly protruding flange composed of an opaque resilient material which effectively seals the individual's skin around the area of contact. In this way egress of light from the interior of the helmet is prevented.
Preferably, the apparatus is provided with cooling means such as fans, thermoelectric/peltier devices or the like so as to prevent the means for emitting electromagnetic radiation overheating.
Preferably, the apparatus of the invention is portable.
It will be appreciated that the apparatus of the invention can be used to direct light to via the transcutaneous transosseous route of the skull but that areas of the skull
substantially bereft of hair, such as the forehead/frontal lobes and/or temple regions are the preferred sites to receive light because the presence of hair can reduce and/or scatter the light and effect the power intensity at the treatment site.
Preferably the wavelength of the electromagnetic radiation is in the range 980nm- 1300nm. A particularly preferred wavelength is at. or about, 1072nm. A yet further particularly preferred wavelength is at, or about, 1268nm.
Our studies have shown that the wavelength centred around 1072 nm is particularly effective at treating neurological and psychiatric conditions. It is of note that the two preferred wavelengths correspond to the peak emission wavelengths of a water molecule light transmission profile and thus we believe that the mechanism of action is related to water and possibly cell membranes.
Preferably, the electromagnetic radiation is divergent and more preferably is at least 5° and up to 40° half angled divergent.
By divergent it meant that the electromagnetic radiation emitted from the system of the invention has a divergent half angle of at least 5°. Preferably divergence of the electromagnetic radiation is in the range 15° to 40° half angled divergent.
Preferably the electromagnetic radiation is continuous or pulsed.
Preferably when the electromagnetic radiation is continuous the intensity is at least 15 mWatts/crrT and up to 2 Watts/cm", and more preferably is in the range 300 -700 mWatts/cm , most preferably it is 500m Watts/cm".
Preferably when the electromagnetic radiation is pulsed the intensity is at least 20 m Watts/cm" peak power and up to 10 Watts/cm", and more preferably is in the range 300 -700 mWatts/cm2, most preferably it is 500mWatts/cm2.
The average power is the peak power multiplied by the proportion of the total time that the radiation is applied. For instance if the peak power is 500 m Watts/cm ~ and is pulsed for 10 μseconds at a frequency of 600 Hz then the average power is 3m Watts/ cm2 .
Preferably when the electromagnetic radiation is pulsed the average power of the intensity is in the region of 50-100 mWatts/ cm2.
Preferably when the electromagnetic radiation is pulsed it is applied for periods of at least 30 seconds and more preferably is applied at a frequency/repetition rate in the range 480-800 Hz more preferably still the frequency/repetition rate is at, or about. 600 Hz.
Our studies have shown that the electromagnetic radiation can be either coherent or non-coherent the clinical outcomes are not affected by this parameter.
It should be appreciated that the power source emitting the electromagnetic radiation will have to produce more than the required intensity for the clinical effect since we have shown that approximately 99% of the applied therapeutic amount of light is lost across the skin surface during treatment. Thus the intensity of applied radiation will have to be corrected for when carrying out a treatment.
From the foregoing it is understood that the electromagnetic radiation may be directed to the target site either continuously or in a switched (pulsed) manner. The main benefit of switching enables power conservation and facilities much higher peak power output, thereby improving clinical response.
Preferably, the apparatus also includes means for reducing the amount of ambient radiation which impinges on the site to which the electromagnetic radiation is applied.
Preferably the apparatus further includes means for fixing the intensity of the radiation within a pre-determined range. The radiation output may be monitored with a visible display indicating correct function of the device both for intensity and wavelength.
Preferably the apparatus includes means for controlling the duration of the application of the radiation. Accordingly, the present invention is concerned with the use of electromagnetic radiation having a wavelength in the range from visible to infra red and applied at a low intensity such that no thermal damage is caused to any human or animal tissues.
The radiation producing means are preferably solid state light emitting devices, more preferably solid state light emitting diodes, gas discharge devices or lasers such as YAG lasers.
Preferably, the radiation emitter includes a PN junction arranged to emit radiation with a wavelength centring at or about 1072nm or at or about 1268 nm. A single light diode assembly may include a plurality of orientated junctions.
Infrared emitting diodes may be arranged not only to emit radiation at a specific frequency but also to emit a high intensity divergent beam.
A gas discharge device may include a mixture of gases which will give an output at the desired wavelength, for instance, 1072 nm.
Another preferred radiation producing means is a laser diode device, an example being a laser diode emitting light at a frequency of 1072 nm. Such a light emitting means is of low power intensity having a divergent beam and not giving rise to thermal damage.
The present invention also provides the use of electromagnetic radiation having a wavelength of between 980 and 1350 nm and an intensity of at least 15 m Watts/cm and up to 10 Watts/cm' to treat neurological and/or psychiatric conditions.
Preferably the electromagnetic radiation as produced by the apparatus of the invention includes any one or more of the preferred features herein before described and more preferably provides for use of electromagnetic radiation in the treatment of conditions such as, without limitation, depression, stress, anxiety, cerebral oedema/trauma, sexual dysfunction, memory loss, dementia and neurodegenerative conditions such as Parkinson's disease.
The present invention also provides a method of treating an individual suffering from a neurological and/or psychiatric condition comprising applying electromagnetic radiation to an area of an individual's head, neck or spine electromagnetic radiation having a wavelength of between 980 and 1500 nm at an intensity of at least 15 mWatts/cm and up to 10 Watts/cm .
Preferably, the area to be treated is irradiated so that the skin surrounding the skull or spinal column receives at least 300-700 mWatts/cm peak power of radiant energy. A factor here is the period of irradiation and, preferably, the period should be at least a specified minimum of 30 seconds at a repetition rate /frequency of 450-800 Hz and preferably for at least two consecutive days and up to several months more preferably still the treatment is over several weeks.
Preferably, the electromagnetic radiation is applied to the affected area for at least a few minutes and up to an hour. N typical exposure time is in the region of 3 minutes per day.
Preferably, the electromagnetic radiation is applied for at least two consecutive days and up to several weeks depending on the nature and severity of the condition.
Preferably, after a first course of electromagnetic radiation has been applied a second or subsequent course is applied over a period of several months, typically it is applied every month or so or twice yearly depending on the severity and nature of the condition.
Preferably, the area to be treated is substantially the skin around the skull, spinal column and/or neck and more preferably is of several cm2 in area.
According to a yet further aspect of the invention there is provided a radiation emitting means in the manufacture of an apparatus for electromagnetic radiation therapy for use in the treatment of neurological and/or psychiatric disorders, said means for emitting electromagnetic radiation being capable of emitting radiation having a wavelength of from 980 to 1350 nm.
Brief Description of the Drawings
Embodiments of the invention will now be described, by way of examples only, and with reference to the accompanying drawings, in which: -
Figure 1 represents an electromagnetic radiation emitting source of a first embodiment of an apparatus in accordance with the present invention;
Figures 2 represents a front view of a first embodiment of an apparatus in accordance with the present invention;
Figures 3 represents a front view of an apparatus of a second embodiment of the present invention; and Figures 4 represents a side cross sectional view of Figure 3 of an apparatus of a second embodiment of the present invention;
Detailed Description of Preferred Embodiments
Referring to Figures 1 there is shown a means for emitting electromagnetic radiation A. The means being a solid state light emitting device such as a solid state light emitting diode or a gas discharge device or a laser such as a YAG laser. Typically
the light emitted is 1072 + 00nm. In use. the light sources can be held in position against an individual's temple region separately but a preferred embodiment of the invention provides a pair of means for emitting electromagnetic radiation A connected together.
The means for emitting electromagnetic radiation A comprises a central portion 1 which emits the light and a perimeter or peripheral region 3. Region 3 is raised with respect to region 1 and is constructed of a suitably soft and opaque material such as foam so as to prevent light escaping beyond region 3 whilst providing comfort for the user.
The apparatus of the first embodiment of the invention provides a headset arrangement B as depicted in Figure 2. The apparatus comprises a pair of light emitting means A housed within units 4, each unit being connected via a bridge member 2. The bridge member is shaped so that it may be worn about an individual's head. The bridge means is typically composed of a resilient material such as plastics and it can be worn over the top, around the back or across the forehead of an individual. Housed within units 4, the apparatus may be provided cooling fans thermoelectric/peltier devices or the like (not shown) so as to prevent the means for emitting electromagnetic radiation overheating. In use and when worn the units 4 containing the light emitting means are positioned so that the perimeter or peripheral region 3 is in contact with the user's skin typically over the temple region of the skull. Light treatment is carried out for a pre-set predetermined period after which the light sources can removed or rotated/moved around the head to another treatment site.
The apparatus emits a single wavelength at any one time, preferably in the infrared spectrum. However, the effective wavelengths, which may be covered by such an apparatus, extend from the visible spectrum to the infrared. In another embodiment of the invention, two wavelengths are used, one that is visible and the other that is invisible, particularly in the case where the optimal wavelength is in the infrared.
The radiation source is provided with two On/Off switches (not shown), which may be actuated to initiate the operation of the internal electronics. Both switches have to be pressed simultaneously in order to operate the device correctly, thereby preventing inadvertent use of the device.
The radiation source is provided with control electronics (not shown), which limit the time that the radiation source is on and then automatically switches off the radiation source. The control electronics monitor the ambient radiation and. in the event that the ambient radiation is of an intensity that would interfere with the therapeutic effect of the radiation source, an alarm buzzer (not shown) sounds.
With reference to Figures 3 and 4 there is shown a front view and a side cross sectional view respectively of a second embodiment C of the apparatus of the present invention. In this embodiment, the apparatus is a helmet designed to be worn substantially over an individual's head. The helmet is therefore shaped accordingly and is domed. It is provided with an array of light sources directing light to an inner surface 4 of the helmet. When worn, the areas of the helmet corresponding to an individual's forehead and temple region 5 are provided with light sources of higher optical power density. The helmet is also provided with a protrusion 6 in the form of resilient opaque material such as foam so as to prevent egress of light from the helmet interior thus protecting the eyes of the individual to be treated. The helmet is also provided with cooling fans or the like to prevent the light emitting means from over-heating. In this embodiment the whole area of the brain may be treated simultaneously. Alternatively selected areas may be treated, thus it will be appreciated that the array of light emitting units within the helmet may be independently controlled for both power intensity and duration.
Experimental Results
Examples of the invention will now be described with reference to the treatment of particular conditions.
Dementia
The study group comprised 5 patients suffering from dementia and with average Mini Mental Test Scores 10/30. Treatment was focused over the frontal, temporal and parietal lobes at a light intensity of between 500 μWatts/cm2 to 10 Watts/cm2 for 8 minutes. The higher light is preferably pulsed which does not impair efficacy. However, we have found that a direct correlation in the surface area of skin receiving light and efficacy of treatment, moreover efficacy can be further improved by simultaneously treating different sites. The treatment was applied on three consecutive days initially and subsequently for twice weekly over a period of eight weeks. We found that at the end of the treatment protocol the average Mini Mental Test Scores was 20/30.
In Alzheimer's dementia there is neuronal degeneration with associated impairment of cellular function including the impaired production of neuro transmitters. Initial treatment of an individual using the apparatus of the invention causes a release of neurotransmitters into the synaptic cleft where they are taken up again and/or degraded. The extra release of neurotransmitters is manifest by a slight increase in activity for the period of 18 hours post-treatment, however this is followed by a slight decline in function for the period 24-48 hours post-treatment. We have found that to achieve maximal stimulation of cell repair and regeneration a subsequent treatment is required during this period.
The results from the five study patients indicate that the apparatus and method of treatment of the invention has the capability of improving degenerative conditions such as dementia and causing overall rejuvenation. The improvements observed in
the Mini Mental Test Scores before and after treatment imply that this invention has use in treating individuals suffering from dementia. Moreover, it offers the advantage of allowing dementia suffers to remain in the community as opposed to institutionalised care. Thus, the present invention would also be of benefit to the health and medical services in that the invention offers a simple and inexpensive therapy to dementia sufferers and will reduce the demand for more expensive and resource draining permanent institutional care.
Parkinson's Disease
A single male subject suffering from Parkinson's disease was treated over the frontal and temporal areas, occipito parietal junction and base of the skull overlying the brain stem. The duration of the therapy was 8 minutes on each area on two consecutive days per week.
After the first week of treatment the patient reported, by subjective evaluation, that he felt an improvement in his general condition. Objective evaluations over several weeks showed that the patient suffered less facial spasms and less tremor whilst asleep. Further light treatments were associated with progressive improvements it was estimated that the light therapy had reversed the progression of the disease by some 6-8 months.
Depression
Depression is an extremely common disorder affecting the majority of the population at some time in their lifetime. The study group comprised 7 individuals, the treatment protocol adopted for the clinically depressed individuals was as follows:
Treating the frontal and temple regions of the skull for 15 minutes twice daily initially reducing treatment time to 8 minutes once a day once clinical resolution had occurred. Thereafter treatment was given for 8 minutes once a week.
As with previous pathologies there can be a transient worsening of mood initially for the first 1-2 treatments. However, a rapid improvement in mood was observed after the first week to a point of euthvmia. Motivation and concentration were found to improve after 72 hours of the first treatment.
Sexual Dysfunction
The study group comprised 10 males and 5 females.
Light at 1072nm appears to have its effect by the release of neurotransmitters in the brain which are responsible for sexual arousal in both male and female. In the male this results in an increased basal blood flow through the genitals, especially the penis with an associated increase in volume of the testes. As the basal blood flow of the penis is higher the threshold for an arousal response is lowered resulting in sustained erection. In the female, the neurotransmitter release is associated with an increase in vaginal secretions. Light at 1072nm is associated with ongoing intracellular production of these neurotransmitters to an optimal level which results in a sustained improvement in sexual function in both males and females.