DE102019127098A1 - System for the local activation of the human eye and the brain for visual performance training, in particular for the activation of the visual cortex and reorganization of neural networks in the human brain to strengthen residual vision - Google Patents

Abstract

The invention relates to a system for local activation of the nervous system in the human eyes and in the brain by means of non-invasive pulse treatment for strengthening residual vision in existing visual field defects, consisting of an applicator for guiding a current flow to the eye and / or brain and for stimulating blood circulation and activation of nerve cells, in particular nerve cells of the visual system and retinal ganglion cells, a pulse generator for generating electrical stimulation signals and a data processing and control unit for providing patient-specific stimulation signal sequences, the applicator having at least two electrodes which can be brought into contact with the subject's head. Exchangeable stimulation electrodes are fixed to the applicator in such a way that they rest or rest on the right and left of the eye in the area of the temple of the patient's head. In addition, the applicator has at least one arrangement for the non-invasive determination of the blood flow to the skin and the brain and for the determination of the oxygen saturation in order to improve the stimulation effect in this regard when the system is used.

Description

The invention relates to a system for the local activation of the human eye and the brain for visual performance training, in particular for the activation of nerve cells in the human eye and brain for strengthening the residual vision in existing visual field defects by means of non-invasive pulse treatment, in particular alternating current pulse treatment (tASC), consisting of an applicator for guiding a current flow to the eye and / or to the brain and for stimulating the blood flow and activation of nerve cells of the visual system, in particular retinal ganglion cells, a pulse generator for generating electrical stimulation signals and a data processing and control unit for providing patient-specific stimulation signal sequences, the applicator at least two Has electrodes which can be brought to bear on the head of the test person, according to the preamble of claim 1.

Visual field defects have so far been considered irreversible, as nerve cells in the retina, the optic nerve and the brain cannot regenerate. However, it has been shown that partial recovery of visual field defects is possible, since the brain, which evaluates and interprets retinal signals, can permanently strengthen the residual signals via certain mechanisms. There are also nerve cells in the retinal that reduce their function after a pathological event and “mute” because they can no longer send out nerve signals without dying.

Since experience shows that almost all patients still have residual vision, that is, what is known as residual vision, it was proposed to reactivate the "silent" nerve cells and to improve the residual visual performance by improving synaptic transmission. Clinical studies show the success of eye training or alternating current stimulation treatments. With AC treatment, the entire retina and parts of the brain are activated and synchronized. The vast majority of patients respond well to the forms of therapy mentioned above. Physiological studies of the mechanisms of alternating current with EEG and fMRI indicate a massive local and global change in blood flow and the reorganization of neural networks in the brain. Local activation of the nerve cells takes place in the eyes and in the visual system of the brain via a global reorganization of neural networks. As residual vision can be strengthened by reactivating nerve cells and modulating neuroplasticity, not only the eyes but also the brain are of great importance for visual rehabilitation in ophthalmology.

For some time now, the adaptability of the brain, also known as plasticity, has been used in ophthalmology. Using methods of neuromodulation using weak alternating currents, partially damaged visual functions can be strengthened through the process of neuroplasticity.

More recently, methods for improving blood flow and resynchronizing the network activity of the brain using alternating current pulses have been tried and tested in partially blinded patients. With the help of special electrodes on the forehead, alternating current is administered non-invasively for several days in defined sessions. The alternating current flows from the electrodes to the eye, where it stimulates retinal ganglion cells to fire at predetermined frequencies with the aim of resynchronizing brain networks. Damage to the optic nerve leads to a disorganization of functional networks in the brain, which is noticeable in the EEG through neurophysiological desynchronization. Treatments using alternating current can significantly improve this condition by improving blood flow and resynchronizing brain network activity.

The resynchronization of visual performance, however, varies greatly from person to person and depends on a wide variety of factors.

In addition to optimizing the stimulation pulses, it is also important to keep the patient largely stress-free, at least during the treatment. For this purpose, there is a need to create an optimized design of stimulation electrodes including technical means for holding these electrodes on the patient's head. An applicator must therefore be created that is both ergonomically optimal and particularly suitable in terms of treatment technology and which meets all requirements.

It is also essential to optimize the stimulation in such a way that the success of the treatment is maintained even beyond the stimulation time and for as long as possible.

Regarding the state of the art with regard to the aforementioned aspects, refer to the EP 1 603 633 B1 which shows a special attachment member for a stimulation device at a desired position on the patient's head, wherein an adjustment structure is made of a deformable material, which is able to adapt the device to the contours of the patient's head.

Fastening devices or arrangements for contacting stimulation electrodes are also in the EP 1 708 787 and EP 1 734 877 B1 disclosed.

With regard to the state of the art with regard to brain stimulation with additional control of the blood flow behavior of neighboring vessels, reference should also be made to the WO 2011/106660 A1 and the WO 2016/115392 A1 made aware.

In the WO 2011/106660 A1 is geared to the recognition of the effect of a stimulation and in particular the simultaneous stimulation and detection of the stimulation effect in real time. For this purpose, a functional near-infrared spectroscopy is used in a non-invasive way during the stimulation. Functional near-infrared spectroscopy is used to measure the oxygenation status of hemoglobin.

The WO 216/115392 A1 relates to devices and methods for determining neurovascular reactivity using stimulation of the neurovascular system and simultaneously recording a neuronal hemodynamic response thereto.

With regard to the various possibilities for the formation of stimulation electrodes and corresponding applicators, attention should be drawn to the prior art briefly outlined below.

The U.S. 5,522,864 A discloses a headband-like electrode holder. A first electrode is placed on a patient's closed eyelid. The second electrode is fixed in the headband. A third electrode is placed in the neck area. Such an electrode design, in particular the application of an electrode to a closed eyelid, is perceived by the patient as uncomfortable and puts him under stress that is negative for the success of the treatment.

Even with the patent family around the EP 30 13 414 B1 , which shows a stimulation device for transdermal electrical stimulation, a plurality of electrodes are fixed at positions which are clearly separated from one another. A first electrode is attached to the patient's forehead area. A second electrode is located on the patient's neck or shoulder. This electrode arrangement is difficult to customize and can only be optimally positioned by the patient with the help of third parties, which is a considerable disadvantage for home therapy.

In the EP 33 49 844 A1 it is about treatment through the application of microcurrents. In this regard, punctual stimulation electrodes are attached above and below the eye in the lid area. Such positioning directly in the sensitive eye area is uncomfortable for a large number of patients, in particular because the electrodes are relatively small and therefore do not allow a sufficient current strength. Even very small currents can be felt, but they are not therapeutically effective. Especially in the area above and below the eye, the human skin is very sensitive to irritation, so that such an electrode design has not found any noteworthy widespread use.

The EP 2 981 326 B1 shows a head-set-like arrangement for electrical stimulation of the skin surface of the head.

A spectacle-like carrier for stimulation electrodes is disclosed in US Pat DE 10 2011 055 844 B4 , with an additional nose support, similar to typical glasses. The electrodes there are removable, that is to say exchangeable. In this arrangement, however, hair electrodes are used which lie directly on the cornea of the eyeball, which entails risks of corneal damage.

In the EP 2 651 504 B1 a headband is provided as an electrode carrier for neurostimulation, the headband coming to rest in the head area of the patient and related electrodes coming to rest symmetrically on the back of the patient's head. There are also electrical connections for connecting the electrodes to a separate pulse generator.

In the device according to the US 2006/129207 A for the electrical stimulation of ganglion cells, a spectacle-like structure is assumed that has electrodes that are connected to the test subject's eyelid. The otherwise unpleasant pressure on the eyelids is to be minimized by means of a support, which, however, results in the disadvantage that the size of the contact resistance between the electrodes and the subject's skin is not always clearly reproducible.

In summary, the prior art shows a large number of different applicators for electrical stimulation, also for the case of local activation of the eyes and the brain, which is relevant here, with the majority of the known applicators for home therapy, i.e. in the sense of a reproducible, simple, and risk-free application is not suitable for the patient without medical or medical assistance.

For this reason - and ultimately also for cost considerations - large-area adhesive stimulation electrodes are currently predominantly used are used, which are attached to the respective test person or patient according to the experience of the medical staff. The advantage of larger electrodes is that a sufficient current strength can be administered, since the current flow penetrates into the skin, eyes or skull over a larger area. In this regard, a trial-and-error method is often used, with the result that reproducibility is only very limited. Home applications, especially those based on adhesive electrodes, are almost impossible, so that an outpatient preparation of the therapy is basically necessary.

The prior art therefore reports very different electrode sizes and positions, which, however, are very variable in their effect and therefore not sufficiently reproducible. It is therefore desirable to enable a suitable electrode placement that can modulate the visual system even with lower currents and with less variability.

From the above, it is the object of the invention to carry out an individual adjustment of the electrodes on the basis of the specific physical conditions of the patient. For this purpose, a new type of system is to be created which, on the one hand, creates an optimal arrangement of the stimulation electrodes and which ensures a lasting effect after the stimulation treatment and not only during it.

The object of the invention is achieved with a system according to the combination of features according to claim 1 and a special application according to the teaching according to claim 18 or 19, the subclaims comprising at least useful configurations and developments.

It is an essential aspect of the invention to allow the applicator to be used intuitively, whereby an optimal stimulation sequence can be found via an arrangement for the non-invasive determination of the blood flow to the skin and the brain of the test person and for the determination of the oxygen saturation Increased blood flow and leads to the longest lasting aftereffect, such that the increase in blood flow and neuronal activation last as long as possible even after the stimulation, which is a clear indicator of the desired success of the treatment.

The pulse generator for generating the stimulation signal sequences can be a single-channel or multi-channel stimulator which interacts with a data processing and control unit so that patient-specific stimulation signal sequences are generated.

The temple positioning according to the invention makes it possible to stimulate both eyes at the same time with only one channel, which reduces the cost of manufacturing the stimulation generator and increases the effectiveness and reliability, i. H. a lower variability of success improves.

The optimal stimulation signal sequences can be determined during an initial treatment under medical supervision, then saved and given to the patient on a patient memory card for home use. It is also possible to store data directly in a memory unit of the applicator.

According to the invention, the applicator is constructed in such a way that, after a brief explanation of the handling, it can be used intuitively, especially in the home.

Since it has been shown that the treatment is particularly successful when the patient is kept stress-free immediately before but also during the treatment, the applicator in one embodiment of the invention has sound generating means, in particular designed as earphones or headphones. On the one hand, this sound generating means can be used to convey to the patient how he is to operate the applicator, which program is to be selected, how long the treatment duration lasts or the like. In addition, voice messages, tone sequences or music can be played in as a desired relaxation reaction.

The applicator according to the invention thus comprises an electrode holder which can in particular be individually adapted to the shape of the head. The electrodes are also positioned at the temples for optimal stimulation. This has the advantage that the current strength of the pulse trains can be reduced and still sufficient phosphenes are produced. A NIR feedback system can maximize the hemodynamic aftereffect in the non-invasive eye and brain simulation.

In the course of extensive investigations and studies, going back to the applicant, it has been shown that the arrangement of the electrodes plays a decisive role in the success of the stimulation of the visual system.

In this regard, a so-called F7-F8 arrangement according to the nomenclature of the EEG 10-20 system is proposed in the area of the patient's temples. With such an arrangement, phosphenes are registered, with extremely low currents in the range of less than 2 mA at an alternating current frequency in the range of 8-25 Hz. If electrodes are positioned in the F7-F8 area, the patient can close his eyes or keep them open in a dark room. There is no uncomfortable pressure in the area of the eyelid or above or below the eye due to attached or applied electrodes.

If you use wet electrodes and arrange them in the area F7-F8, there is also a very pleasant cooling effect, which leads to stress reduction, reduces skin resistance and also improves the success of the treatment.

Prior to the above, the invention relates to a system for the local activation of the human eyes and the brain for the reorganization of neural networks for strengthening the residual vision and improving the blood circulation in the case of existing visual field defects. In this regard, pulse current treatment, in particular non-invasive alternating current pulse treatment, is used.

The system consists of an applicator to guide the flow of electricity to the eye and brain and to stimulate blood flow and activate nerve cells, especially retinal ganglion cells.

The system also includes a pulse generator for generating electrical stimulation signals and a data processing and control unit for providing patient-specific stimulation signal sequences.

The applicator has at least two electrodes which can be brought into contact with the head of the test person in the manner explained below.

According to the invention, interchangeable stimulation electrodes are fixed on the applicator in such a way that they rest or rest on the right and left of the eye in the area of the temple of the patient's head, that is to say in the so-called F7-F8 area.

Furthermore, the applicator has at least one arrangement for the non-invasive determination of the blood flow to the skin and the brain and for the determination of the oxygen saturation, in particular on the basis of fNIR spectroscopy.

An NIR emitter and the at least one associated NIR detector are positioned at a distance from the stimulation electrodes on the patient's head and separately from the stimulation electrodes.

The NIR spectroscopy data, in particular during breaks or at the end of stimulation signal sequences, are recorded in order to determine the duration of a sustained, improved blood flow and / or oxygen saturation, so that the data processing and control unit can then be operated using the system according to the invention.

In a further development of the invention, the applicator can be individually adapted to the shape of the patient's head. For this purpose, adjustment means known per se are designed with regard to the fixation on the forehead and back of the head area of the patient.

In one embodiment of the invention, the applicator is designed as a ring-shaped or crown-shaped structure that can be placed on the head, with a nasal bridge support and / or an ear support and / or a back of the head support being provided.

In addition, a receptacle for electronic components and for weight compensation can be provided in the back of the head. The electronic components can include a battery or an accumulator, so that the applicator can be used for power supply without external cabling.

In one embodiment of the invention, the stimulation electrodes are designed as dry or wet cushion electrodes.

In the case of a wet pad electrode, an electrolyte can be used as the moisture solution in order to reduce the contact resistance between the respective conductive component in the electrode and the surface of the patient's skin. The lower the contact resistance, the lower the current that can be selected for the pulse trains and there is no unpleasant effect in the sense of a typical tingling sensation when an electrical current flow is felt. Fixation points for attaching, in particular clipping on, further electrodes can be provided on the applicator, which enable the application of current, in particular alternating current, also in the area below the patient's eyes, if this is advantageous from a therapeutic point of view.

At least one interface for wired or wireless data transmission is formed on or in the applicator.

In this way, the applicator can exchange information with a higher-level system via a so-called air interface, register the course of the treatment duration and the success of the treatment and make this data available or transmit this data to the attending physician for evaluation and further optimization of the treatment.

In a special embodiment of the invention, sound generating means, in particular designed as earphones or headphones, are provided on the applicator in order to guide the patient through information, in particular on handling the applicator, and / or to relax acoustically during the treatment.

For autonomous operation, the applicator includes both the pulse generator, in particular the alternating current pulse generator, and the data processing and control unit along with power supply, the treatment sequence and / or the stimulation signal sequences being able to be implemented by a computer program product. In this respect, the applicator has all the technical means necessary for use and treatment. It is therefore no longer necessary to provide a separate pulse generation unit that is either wired next to the patient or is to be carried by the patient, for example as is realized in the known prior art by devices that are for example on the belt or in the patient's pocket be fixed or worn.

An electrolyte reservoir for wetting the electrodes can be provided on or in the applicator. The patient thus has the option of slightly moistening the electrodes himself when the electrodes begin to dry out. Optionally, the supply of the electrolyte via communicating tubes with the electrode holders can also be automatically controlled by a suitable sensor.

In one embodiment of the invention, the applicator and / or holders for holding electrodes are made of a deformable plastic material. This makes it possible to adapt the applicator individually to certain head shapes, in particular in the forehead, nose or neck area of the patient, and thereby to carry out an actual individualization for the patient in question.

The mounts and / or the stimulation electrodes can consist of a conductive plastic material, so that the construction of the applicator is simplified and the power supply or the forwarding of the stimulation pulse trains can be implemented using such a conductive material.

It is within the meaning of the invention that there is a pocket or a similar receptacle for replacement electrodes on the applicator. If an exchangeable electrode is lost, the treatment can be continued, which is particularly advantageous if the patient to be treated is not in the vicinity of the medical practice that would otherwise take care of him.

In particular for stationary or clinical applications, the applicator can be designed to be combined with an EEG electrode hood known per se.

As already indicated, the applicator can have a unit for determining the contact resistance between the stimulation electrodes and the skin surface of the patient in order to switch off the pulse generator or to reduce the flow of current in the event of abnormal, in particular excessively high contact resistances.

It has been shown that the system according to the invention for local activation of the human eye and the brain can also be used to improve visual performance, in particular for the activation of nerve cells in the human eye and brain, for those persons or subjects who are exposed to extreme gravitational and / or Environmental conditions sometimes have to perform complicated activities, as is the case, for example, with pilots, space travelers, but also deep-sea divers.

By treating these people before, during and / or after their use under the extreme conditions described, the visual performance is maintained and concentrated and safe work is possible.

In an embodiment of the invention, there is the possibility of designing or adapting the applicator presented in such a way that it can be integrated into special equipment for the above-mentioned persons. This is particularly about integrating the applicator into a pilot's, spaceman or deep-sea diving helmet.

QUOTES INCLUDED IN THE DESCRIPTION

This list of the documents listed by the applicant was generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Patent literature cited

• EP 1603633 B1 [0009]
• EP 1708787 [0010]
• EP 1734877 B1 [0010]
• WO 2011/106660 A1 [0011, 0012]
• WO 2016/115392 A1 [0011]
• WO 216/115392 A1 [0013]
• US 5522864 A [0015]
• EP 3013414 B1 [0016]
• EP 3349844 A1 [0017]
• EP 2981326 B1 [0018]
• DE 102011055844 B4 [0019]
• EP 2651504 B1 [0020]
• US 2006129207 A [0021]

Claims (20)

System for the local activation of the human eye and the brain for visual performance training, in particular for the activation of nerve cells in the human eye and brain to strengthen residual vision in existing visual field defects by means of non-invasive alternating current pulse treatment (tACS), consisting of an applicator for guiding a current flow to the eye and Brain and for stimulating the blood flow and activation of nerve cells, in particular retinal ganglion cells, a pulse generator for generating electrical stimulation signals and a data processing and control unit for providing patient-specific stimulation signal sequences, the applicator having at least two electrodes which can be brought into contact with the head of the test person , characterized in that on the applicator, in particular exchangeable, stimulation electrodes are fixed in such a way that they are located on the right and left of the eye in the area of the temple of the patient's head he concern. System according to Claim 1 , characterized in that the applicator can be individually adapted to the head shape of the patient and adjustment means are designed for this purpose with regard to the fixation on the forehead and back of the head of the patient. System according to Claim 1 or 2 , characterized in that the applicator is designed as a ring-shaped or crown-shaped structure that can be placed on the head, with a nasal bridge support and / or an ear support and / or a back of the head support and in the back of the head a receptacle for electronic components and for weight compensation are provided. System according to Claim 1 or 2 or 3rd , characterized in that the stimulation electrodes are designed as dry or wet cushion electrodes. System according to one of the preceding claims, characterized in that fixing points are provided on the applicator for attaching, in particular clipping on, further electrodes which enable alternating current to be applied even in the area below the patient's eyes. System according to one of the preceding claims, characterized in that an interface for wired or wireless data transmission is formed on or in the applicator. System according to one of the preceding claims, characterized in that sound generating means, in particular designed as earphones or headphones, are provided on the applicator in order to guide the patient through information during the alternating current pulse treatment and / or to relax acoustically. System according to one of the preceding claims, characterized in that, for autonomous operation, the applicator comprises both the alternating current pulse generator and the data processing and control unit together with a power supply, the treatment sequence and / or the stimulation signal sequences being realizable by a computer program product. System according to one of the preceding claims, characterized in that a moisture reservoir for wetting the electrodes is provided on or in the applicator. System according to one of the preceding claims, characterized in that the applicator and / or holders for holding electrodes consist of a deformable plastic material. System according to Claim 10 , characterized in that the holders and / or the stimulation electrodes consist of a conductive plastic material. System according to one of the preceding claims, characterized in that there is a pocket on the applicator for receiving replacement electrodes. System according to one of the preceding claims, characterized in that the applicator is designed to be combinable for combination with an EEG electrode hood known per se. System according to one of the Claims 3 - 13th , characterized in that the electronic components have a power supply, in particular a battery or an accumulator. System according to one of the preceding claims, characterized in that a unit for determining the contact resistance between the stimulation electrodes and the skin surface of the patient is designed in order to switch off the pulse generator in the event of abnormal, in particular excessively high, resistances. System according to one of the preceding claims, characterized in that the applicator has at least one arrangement for the non-invasive determination of the blood flow to the skin and the brain and for the determination of the oxygen saturation, in particular on the basis of fNIR spectroscopy, wherein the NIR emitter and the at least one associated NIR detector in a remote position can be positioned by the stimulation electrodes on the patient's head and separately from the stimulation electrodes, and the NIR spectroscopy data, in particular during breaks or at the end of stimulation signal sequences, are recorded in order to determine the duration of a sustained, improved blood flow and / or oxygen saturation, so that an updated operation of the data processing and control unit can then be implemented. System according to one of the preceding claims, characterized in that the position of the stimulation electrodes corresponds to an F7-F8 arrangement according to the nomenclature of the EEG 10-20 system. System for the local activation of the human eye and the brain to improve visual performance, in particular for the activation of nerve cells in the human eye and brain, by means of non-invasive alternating current pulse treatment, consisting of an applicator for guiding a current flow to the eye and brain and for stimulating the blood circulation and activation of Nerve cells, a pulse generator for generating electrical stimulation signals and a data processing and control unit for providing subject-specific stimulation signal sequences, the applicator having at least two electrodes which can be brought into contact with the subject's head and the stimulation electrodes are fixed in such a way that they are to the right and left of the subject Eye in the area of the temple of the patient's head resting or resting, the application before, during and / or after the use of people who carry out activities under difficult gravitational or environmental conditions on them People, such as in particular pilots, space travelers, deep-sea divers or the like, takes place. Applicator according to one of the Claims 2 to 17th , characterized by the use before, during and / or after the use of people who carry out activities under difficult gravitational or environmental conditions on these people, such as in particular pilots, space travelers, deep-sea divers or the like. Applicator after Claim 19 , characterized in that this is part of special equipment to be worn on the head or to protect it, in particular a pilot's, spaceman or deep-sea diving helmet.