PHOTOTHERAPEUTIC APPARATUS
20230256262 · 2023-08-17
Assignee
Inventors
Cpc classification
A61N2005/0626
HUMAN NECESSITIES
A61B5/374
HUMAN NECESSITIES
A61B5/0077
HUMAN NECESSITIES
A61B5/4836
HUMAN NECESSITIES
International classification
Abstract
A phototherapeutic apparatus for emitting therapeutic light, the apparatus comprising: a first set of one or more light sources and a second set of one or more light sources; a control module configured to control the first and second set of light sources; wherein the control circuit is configured to: control the first set of light sources to generate first light, the first light varying periodically at a first brain stimulation rate; control the second set of light sources to generate second light concurrently with the first set of light sources generating the first light, the second light varying periodically at a second brain stimulation rate equal to the first brain stimulation rate plus a third brain stimulation rate, wherein the third brain stimulation rate is selected for stimulating neural oscillations at a beat frequency corresponding to said third brain stimulation rate
Claims
1. A phototherapeutic apparatus for emitting therapeutic light, the apparatus comprising: a first set of one or more light sources and a second set of one or more light sources; a control module configured to control the first and second set of light sources; wherein the control circuit is configured to: control the first set of light sources to generate first light, the first light varying periodically at a first brain stimulation rate; control the second set of light sources to generate second light concurrently with the first set of light sources generating the first light, the second light varying periodically at a second brain stimulation rate equal to the first brain stimulation rate plus a third brain stimulation rate, wherein the third brain stimulation rate is selected for stimulating neural oscillations at a beat frequency corresponding to said third brain stimulation rate.
2. The phototherapeutic apparatus according to claim 1, wherein the first brain stimulation rate is between 20 Hz and 140 Hz.
3. The phototherapeutic apparatus according to claim 2, wherein the first brain stimulation rate is between 20 Hz and 50 Hz, such as between 35 Hz and 45 Hz.
4. The phototherapeutic apparatus according to claim 2, wherein the first brain stimulation rate is between 50 Hz and 140 Hz, such as between 50 Hz and 70 Hz.
5. The phototherapeutic apparatus according to claim 4, wherein the first brain stimulation rate is higher than a critical flicker frequency (CFF) threshold, and wherein the control module is configured to control the first set of one or more light sources to emit light at a varying intensity, varying at the first brain stimulation brain rate.
6. The phototherapeutic apparatus according to any one of the preceding claims, wherein a difference between the second brain stimulation rate and the first brain stimulation rate is between 1 Hz and 140 Hz.
7. The phototherapeutic apparatus according to claim 6, wherein the difference between the second brain stimulation rate and the first brain stimulation rate is between 1 Hz and 10 Hz, such as between 4 Hz and 10 Hz, such as between 4 Hz and 7 Hz.
8. The phototherapeutic apparatus according to claim 6, wherein the difference between the second brain stimulation rate and the first brain stimulation rate is between 20 Hz and 140 Hz, such as between 20 Hz and 60 Hz, such as between 35 Hz and 45 Hz.
9. The phototherapeutic apparatus according to claim 8, wherein the difference between the second brain stimulation rate and the first brain stimulation rate is substantially equal to the first brain stimulation rate, such as between 20 Hz and 60 Hz, such as between 35 Hz and 45 Hz.
10. The phototherapeutic apparatus according to any one of the preceding claims, wherein the first brain stimulation rate is smaller than a critical flicker frequency (CFF) threshold; wherein the control module is configured to control the first set of light sources to alternatingly generate first and second colored light, alternatingly at said first brain stimulation rate, the first colored light having a first set of color components and the second colored light having a second set of color components different from the first set of color components; wherein the first and second color components are selected such that the alternatingly generated first and second colored light is perceivable by a human observer as light having a user-perceptible first fused color such as white.
11. The phototherapeutic apparatus according to any one of the preceding claims, wherein the second brain stimulation rate is smaller than a critical flicker frequency (CFF) threshold; wherein the control module is configured to control the second set of light sources to alternatingly generated third and fourth colored light, alternatingly at said second brain stimulation rate, the third colored light having a third set of color components and the fourth colored light having a fourth set of color components different from the third set of color components; wherein the third and fourth color components are selected such that the alternatingly generated third and fourth colored light is perceivable by a human observer as light having a user-perceptible second fused color such as white.
12. The phototherapeutic apparatus according to any one of the preceding claims, wherein one or both of the first and second generated light is white light.
13. The phototherapeutic apparatus according to any one of the preceding claims, wherein the color and/or brightness of the first and/or second light is user-adjustable
14. The phototherapeutic apparatus according to any one of the preceding claims, wherein the first and second light have the same perceivable color and/or the same perceived brightness.
15. The phototherapeutic apparatus according to any one of the preceding claims, comprising a housing configured to accommodate the first and second sets of light sources; the housing defining a light-output panel, in particular a diffuser panel, for outputting the first and second light towards a user; wherein the light-output panel defines a first panel portion and a second panel portion, different from the first panel portion; wherein the apparatus is configured to output the first light at least predominantly through the first panel portion and to output the second light at least predominantly through the second panel portion.
16. The phototherapeutic apparatus according to claim 15; wherein the light-output panel defines a light-output surface area, wherein each of the first and second panel portions have between 30% and 70% of the light-output surface area, such that the first and second panel portions together have between 80% and 100% of the light-output surface area.
17. The phototherapeutic apparatus according to claim 15 or 16; wherein the first and second panel portions are arranged next to each other in a side-by-side configuration.
18. The phototherapeutic apparatus according to any one of the preceding claims wherein the first set of light sources comprises a first set of light emitting diodes (LEDs), and wherein the second set of light sources comprises a second set of light emitting diodes (LEDs).
19. The phototherapeutic apparatus according to any one of the preceding claims, further comprising: one or more EEG sensors for detecting brain waves; and a processing system coupled to detect first signals corresponding to the brain waves and coupled to control one or more attributes of the generated light from the light source to increase one or more predetermined neural oscillation, such as to increase theta-gamma wave coupling in a person's brain.
20. The phototherapeutic apparatus of any one of the preceding claims, further comprising: a processing system; an eye-tracking device that detects said person's eye and provides first data to the processing system, wherein the processing system is configured to use the first data to adjust aspects of a brain stimulation session.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0091] Elements labelled with the same numerals in the various drawings may be the same or equivalent.
DETAILED DESCRIPTION
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[0093] A gamma/theta brain stimulation light system 12 is positioned about 50-100 cm from the person 10. The system may be supported by a table or desk. In another embodiment, the system 5 forms goggles that are worn by the person 10. In one embodiment, the system uses an apparatus as described in connection with
[0094] In one embodiment, a pulsing light source 14 uses blue light LEDs, white light LEDs, or a variety of different wavelength monochromatic LEDs.
[0095] One set of LEDs is energized at 40 Hz (or other first brain stimulation rate e.g. anothr gamma frequency) and another set of LEDs is simultaneously energized at 47 Hz (or other second brain stimulation rate). The combined light 10 perceived by the person's brain will be 40 Hz and a beat frequency (subtraction frequency) of 7 Hz (or another third brain stimulation rate, e.g. another theta frequency or a gamma frequency. The flickering is near to imperceptible at 40 Hz.
[0096] The 40 Hz and 47 Hz frequencies are preferred in one embodiment when gamma-theta coupling is intended, but not required. A gamma brain stimulation rate range between 20 Hz-140 Hz may be effective, and a theta brain stimulation rate range between 4 Hz-10 Hz may be effective. Therefore, the two light flickering frequencies may differ by 4-10 Hz and be in the range of 20-150 Hz. This would result in the brain being stimulated at the gamma frequency and the beta theta frequency.
[0097] In embodiments, where only gamma stimulation is intended, the two light flickering frequencies may differ by 20-150 Hz, such as by between 35 Hz and 50 Hz and be in the range of 20-150 Hz, such as between 35 Hz and 55 Hz.
[0098] In one embodiment, the LEDs are optionally arranged to form a circular light source 14 with a camera lens 16 in the middle. In another embodiment, the light source 14 may be more of a point source, and the camera lens 16 may be next to it. In yet another embodiment, the light source is an extended surface, such as a rectangular surface, and the camera lens 16 may be next to it of embedded in the center of the surface. When the camera is located next to the surface, the gaze angle is adjusted for the offset of the lens and the light source. The light source 14 may instead be a flat two-dimensional array of LEDs, such as 20 cm×20 cm diffused Lambertian source.
[0099] In another embodiment, the LEDs are energized to output light whose amplitude is sinusoidal. In such a case, the energizing currents to different sets of LEDs are 40 Hz and 47 Hz, so there is no perceived flicker.
[0100] In another embodiment, the LEDs are energized for a time (a few seconds) at 40 Hz, followed by being energized for a few seconds at 47 Hz, where the alternation is less than 6 seconds. The brain will perceive the frequencies as being modulated.
[0101] In another embodiment, instead of the light alternating between white and darkness, the light can alternate between different colors at the stimulation frequencies, such as between green and red and between blue and yellow. For example, one light source can alternate at 47 Hz between the colors XX and the color YY, and the other light source can alternate at 40 Hz between the colors ZZ and KK. This is referred to as heterochromatic flicker or Invisible Spectral Flicker (ISF), e.g. as described in M. P. Agger et al. “Novel Invisible Spectral Flicker Induces 40 Hz Neural Entrainment with Similar Spatial Distribution as 40 Hz Stroboscopic Light”, J Alzheimers Dis. 2022; 88(1): 335-344 or as described in Mikkel Pejstrup Agger et al., “Safety, Feasibility, and Potential Clinical
Efficacy of 40 Hz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study”, Journal of Alzheimer's Disease, 92(2), 653-665. https://doi.org/10.3233/JAD-221238. The heterochromatic flicker can be constructed by multiple combinations of waveforms. Such heterochromatic flicker reduces any noticeable flicker yet produces good results. If the colors are of equal luminance (but still different hues), the flicker should be imperceptible.
[0102] The overall dosage of light for the person 10 may be determined by a medical worker based on clinical trials and testing. Optimal dosage levels for different types of persons, such as patients, are still being studied, but a reasonable dosage is one-hour of the person 10 looking directly at the light source 14. Such a session may be performed at the same time every day. The person 10 may be periodically evaluated by a medical worker to correlate the gamma brain stimulation with the effects of Alzheimer's or other disorder. Cognitive testing may be done as 15 well as testing to determine the presence of certain proteins and other chemicals in the person's body. Testing may include an EEG (electroencephalography). It is vital, for evaluation, to know exactly what dosage of light has been given to the person 10.
[0103] The Applicants have discovered that the effective dosage of neural entrainment light is highly influenced by combinations of gaze angle, eye distance from the light source, and pupil 20 size, although compensation for any one of these factors helps achieve the target dosage. When the apparatus emits light from different light emitting surface portions, e.g. in a side-by-side arrangement, the gaze angle is a particularly important parameter. The actual dosage corresponds to a certain brain stimulation session duration given the particular gaze angles, eye distances, and/or pupil sizes during the session. Adjustments for gaze angle are the most significant for achieving the target light dosage.
[0104] The camera 18 (
[0105] A target light dosage is first established by the medical worker for the person 10 and this information is downloaded into the system 12, such as through the Internet. The target light dosage correlates to the session duration, given a known light optical output power and pulse frequency, with the person at a particular distance from the light source with an average pupil size. In one example, this target dosage assumes the person 10 is directly looking at the light source 14 at a distance of 50 cm with an average pupil size. The actual effective dosage, 10 however, is reduced if the person 10 does not look directly at the light source 14, or is further than 50 cm away, or has a smaller than average pupil size.
[0106] As described with respect to
[0107] The detected distance from the light source will have a non-linear correlation to the actual effective dosage since the effect of the light is non-linearly diminished as the person 10 moves from 50 cm to 100 cm from the light source. Similarly, the pupil size has a non-linear effect on the actual dosage.
[0108] Also, as shown in
[0109] An EEG is normally used as a test that detects abnormalities in brain waves or abnormalities in the electrical activity of the brain. During the procedure, electrodes consisting of small metal discs with thin wires are pasted onto the user's scalp or positioned close to the scalp such as by using a headpiece. The electrodes detect weak electrical emissions that result from the activity of the brain cells.
[0110] Some embodiments of the present apparatus instead detect the EEG signals from the brain to detect the coupling of the gamma and theta rhythms and then adjust the phase of the light stimulation pulses to maximize the coupling.
[0111] In
[0112] https://www.semanticscholar.org/paper/Theta % E2%80%93gamma-coupling-in-the entorhinal % E2%80%93hippocampal-Colgin/4d21566e35Off22f4c03628f5dcaf50fa91430b0. Also with EEG, one can also measure the “surrogate/indirect” effect of phase coupling just from the sensor electrodes. In EEG, we can differ between “source space” and “sensor space”. In source space, with enough electrodes, we can measure the phase in the hippocampal and near hippocampal regions (source space), and in sensor space, using for example frontal or occipital electrodes, we can measure the indirect effects of deep brain phase locking. So, preferably, hippocampus measurements within the source space are used to detect the theta-gamma coupling, but, instead, the coupling can be detected by using the sensor space.
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[0114] In
[0115] Suitable gaze detection systems for customization are available from SR Research, Tobi AB, and other companies. A fully customized system can also be fabricated using a Raspberry Pi Camera Module v2 in conjunction with a Raspberry Pi 3 Model B+ single board computer. Much of the software is commercially available.
[0116] The raw digital data from the camera 18 is then processed by a processor running an algorithm in the eye tracking module 22. Such algorithms may consist of publicly available software customized for the present invention. For the present invention, the software uses the resulting information about gaze angle, distance, and pupil size to dynamically control the dosage so that the person 10 ultimately receives the target dosage, in particular when the person is a patient.
[0117] The output of the eye tracking module 22 is then used to adjust the dosage that is controlled by the dosage controller 24. The dosage controller 24 initially receives a target dosage from the medical worker, which may correlate to a one-hour session. This target session time is then automatically extended based on deviations from the ideal conditions of direct gaze, 50 cm 25 distance, and average pupil size.
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[0119] In another embodiment, the current supplied to the light source 14 is sinusoidal, and the energizing current is a gamma frequency and the gamma frequency plus a theta frequency.
[0120] The required session time is displayed to the person 10 on a display screen 28, so the person 10 knows that the session time has been extended due to the person 10 gazing away or being further than 50 cm from the light source 14. The display screen 28 may use data generated by the local system or generated by a remote system communicating via the Internet.
[0121] A memory 30 stores the results of the session so the medical worker has accurate data regarding the dosage. Communications hardware 32 may convey the data to the medical worker and update the system with upcoming session information.
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[0123] In
[0124] The eyes are also detected and processed by quantitative fixed thresholding algorithms (block 42). This process uses contrast thresholds (binarization) to determine objects, such as irises and pupils. Based on this data, the pupil angle is estimated (block 44). From this, the angle of gaze is computed trigonometrically and, after correcting for any off-set (block 46) of the integrated camera 18 lens relative to the light source, the resulting angle is passed to the data packaging block 40 before capturing the next frame. The dosage may be adjusted dynamically from frame to frame or may just be adjusted nearer the end of the session.
[0125] If no face is detected, a “user absence” signal is generated, and no power is applied to the light source. The packaged data is applied to the dosage controller 24 of
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[0127] In step 50, the 40 Hz/47 Hz strobing light source is turned on to emit the stimulating light 52. The gaze detection system detects the person's distance, gaze angle, and pupil diameter (step 54) as the person's eye receives the light (step 56). The brain then undergoes neural entrainment (step 58) (i.e., the capacity of the brain to naturally synchronize its brainwave frequencies with the rhythm of periodic external stimuli).
[0128] The target duration (step 60), provided by the medical worker or other source, is correlated with an expected or target dosage of the light (step 62). The real-time detection (step 64) during the analysis of step 54 is then correlated to any expected loss of dosage (step 66) due to gaze angle, etc. A look-up table may be used to correlate the data with the loss of dosage.
[0129] The dose correction step 68 then subtracts the loss of dose from the “ideal conditions” dose to derive the actual effective dose being received by the person. The effective dose information (step 69) is then used to extend the session, as needed, to achieve the target dose.
[0130] The data obtained from the session and from testing the person, such as in particular a patient, may be used to further the understanding of the effects of the gamma brain stimulation on, for example, Alzheimer's disease or other neurological or psychiatric disorder (i.e., brain network dysfunctions).
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[0132] In step 72, the light source and gaze tracker are activated to start the session.
[0133] In step 74, the detected gaze angle, eye distance, and pupil diameter are correlated with a reduction of the effective dosage.
[0134] In step 76, the session time is extended, as required, to compensate for the detected gaze angle, eye distance, and pupil diameter. In another embodiment, the target dosage presumes some variation from ideal of the detected gaze angle, eye distance, and pupil diameter, and the system can add or subtract from the session time.
[0135] In parallel with detecting the effective dosage, the phase of the light stimulation is controlled to maximize theta-gamma coupling in the brain. The system for adjusting the phase was described with respect to
[0136] In step 80, the EEG signals are processed, and the phase of the light stimulation system is dynamically adjusted so that the two detected EEG signals have a high coupling, such as shown on the left side of
[0137] In step 82, the session data is stored in a memory for evaluating the efficacy of the treatment.
[0138] In step 84, a communications system conveys the data to a clinic or other medical worker. The communications system can also receive information, such as the target dose.
[0139] The system may be used for therapy or just to analyze the effects of the optical gamma/theta brain stimulation on a group of similar persons for collecting further data for study. Other strobing frequencies besides 40 Hz and 47 Hz, as previously mentioned, may prove valuable with further studies.
[0140] The invention is not limited to a gamma/theta brain stimulation rate of 20-140 Hz and 4-10 Hz. Other frequency light pulses emitted by the light source 14 may be beneficial for beta brain waves (beta brain stimulation rate of 13-38 Hz) and circadian functions. By generating light greater than a frequency that causes perceptible flicker, and also generating light at that frequency plus a lower frequency, the original frequency and the subtraction frequency are perceived internal to the brain without the detection of flicker.
[0141] In another embodiment, the system is only used for gamma wave stimulation. For example, the first set of light sources may flicker at a frequency between 40 Hz and 60 Hz and the second set of light sources may flicker at a frequency between 74 Hz and 120 Hz.
[0142] In other embodiment, the optical system of
[0143] The phases of the gamma and theta waves may also be varied for testing the results of different phases.
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[0145] The phototherapeutic apparatus of this embodiment is implemented as a luminaire having a housing 121. The housing accommodates a light emitting member 125, a first set of light sources 124L, a second set of light sources 124R and a control circuit 123.
[0146] In the present example, the light sources 124L and 124R and the control circuit are mounted on a circuit board 122 or other suitable support member.
[0147] The first set of light sources 124L may comprise an array of one or more LEDs. Similarly, second set of light sources 124R may comprise an array of one or more LEDs. Each array of LEDs way include white LEDs or colored LEDs, such as LEDs of multiple different colors so as to be able to create heterochromatic flicker as described herein.
[0148] Operation of the two sets of light sources is controlled by the control circuit 123. To this end, the control circuit 123 may include a suitable power supply and a suitable driver circuit.
[0149] The light emitting member 125 is formed as a diffuser panel which may form part of the housing, e.g. it may form or be embedded in one side wall of the housing. The first set of light sources 124L are configured such that their light is emitted via one portion 125L, in this example, the left-side portion, of the light-emitting member 125. The second set of light sources 124R are configured such that their light is emitted via another portion 125R, in this example, the right-side portion, of the light-emitting member 125. The two portions 125L and 125R each form one half of the total light emitting surface of the light emitting member 125. Accordingly, when the sets of light sources are controlled to flicker at different frequencies, the two surface portions flicker at these different frequencies. In
[0150] In the example of
[0151] The embodiment of
[0152] In the example of
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Efficacy of 40 Hz Invisible Spectral Flicker versus Placebo in Patients with Mild-to-Moderate Alzheimer's Disease: A Randomized, Placebo-Controlled, Double-Blinded, Pilot Study”, Journal of Alzheimer's Disease, 92(2), 653-665. https://doi.org/10.3233/JAD-221238. The experiment was repeated with respective values for the another brain stimulation rate, namely at 32 Hz, 40 Hz, 44 Hz, 45 Hz, 46 Hz, 47 Hz, and 48 Hz. The power spectral densities for the combination of 40 Hz flicker with each of the other brain stimulation rates are shown in
[0156] As can be seen from
[0157] Yet further both combinations having a difference frequency of 8 Hz, i.e. the combination of 32 Hz and 40 Hz (blue line) and the combination of 40 Hz and 48 Hz (pink line) show a clear peak at 8 Hz confirming a considerable stimulation of neural oscillations at the beta frequency in the Theta range. Neural stimulation at the other beat frequencies was also present but at a lesser degree for this particular subject.
Definitions
[0158] The term “gamma/theta brain stimulation” means a stimulus, such as a light source, that can change the neuronal gamma and theta activity in the brain.
[0159] The term “person” means a subject to be subjected to gamma/theta brain stimulation, such as a patient exhibiting symptoms of a brain disease such as Alzheimer's, or such as a person who desires pre-emptive gamma/theta brain stimulation, or a test-person who is subjected to gamma/theta brain stimulation for instructive or test purposes. The term “stimulation session” means a procedure over time where the person is exposed to a brain-stimulating device to receive a certain dosage of light. A single stimulation session is typically conducted within a day, but a customized session can be expanded and individualized to comprise multiple days, weeks, or months.
[0160] The term “stimulation duration” means a time period of a stimulation session, but is not limited to comprising the whole session duration, since the stimulation session time period can be broken up into multiple individual durations allowing for “interval” training, such as 15 minutes×4=60-minute session. Strobing and flickering are used interchangeably in this application.
[0161] While particular embodiments of the present invention have been shown and described it will be obvious to those skilled in the art that changes and modifications may be made without departing from this invention in its broader aspects and, therefore, the appended claims are to encompass within their scope all such changes and modifications that are within the true spirit and scope of this invention.