CN110772717A - Treatment device for treating depression patients through electrically controlled stimulation of tongue surface - Google Patents

Treatment device for treating depression patients through electrically controlled stimulation of tongue surface Download PDF

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Publication number
CN110772717A
CN110772717A CN201911112824.7A CN201911112824A CN110772717A CN 110772717 A CN110772717 A CN 110772717A CN 201911112824 A CN201911112824 A CN 201911112824A CN 110772717 A CN110772717 A CN 110772717A
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China
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tongue
electrode
depression
patient
electrically controlled
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CN201911112824.7A
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Chinese (zh)
Inventor
谢曦
黄爽
杭天
陈惠琄
胡宁
何根
吴倩妮
张涛
吕成林
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Sun Yat Sen University
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Sun Yat Sen University
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Publication of CN110772717A publication Critical patent/CN110772717A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36082Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
    • A61N1/36096Mood disorders, e.g. depression, anxiety or panic disorder
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36125Details of circuitry or electric components

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Radiology & Medical Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Neurology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Neurosurgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Developmental Disabilities (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Electrotherapy Devices (AREA)

Abstract

The invention belongs to the technical field of treatment devices for treating depression diseases. The utility model discloses a treatment device that treats depression patient through electricity accuse amazing tongue surface, including control circuit module and the tongue piece electrode body of mutual electric connection, tongue piece electrode body includes flexible circuit board, is equipped with a plurality of discharge electrode that arrange in pairs corresponding to oral cavity side position on flexible circuit board, is equipped with external electrode corresponding to oral cavity outside position, and discharge electrode and external electrode one-to-one connection, the periphery of flexible circuit board is equipped with cladding material and the encapsulated layer of naked exposure discharge electrode and external electrode from inside to outside in proper order, discharge electrode distributes corresponding to different positions in the tongue. The therapeutic device can simultaneously have higher cure rate of ECT, can act on nerve center more stably with lower stimulation, reduces cost, meets the aim of self-treatment of most depression patients for a long time, and is safe and reliable to use.

Description

Treatment device for treating depression patients through electrically controlled stimulation of tongue surface
Technical Field
The invention belongs to the technical field of treatment devices for treating depression diseases, and particularly relates to a treatment device for treating depression patients by electrically controlling and stimulating the tongue surface
Background
Depression is currently the fourth disease of the world, predicted to be the second disease by 2020; however, the medical treatment and prevention of the depression in China are in the situation of low recognition rate, hospitals above grade city have recognition rate less than 20%, and only less than 10% of patients receive related drug treatment; moreover, at the same time, the onset of depression (and suicidal events) has begun to trend toward a lower age (university, or even a group of primary and secondary school students). In conclusion, great importance is needed to science popularization, prevention and treatment of depression, and the prevention and treatment of depression are listed in the national mental health work key point.
The etiology of depression is not well understood, but it is believed that many factors in biological, psychological and social environments are involved in the pathogenesis of depression. Biological factors mainly relate to the aspects of heredity, neurobiochemistry, neuroendocrine, nerve regeneration and the like; psychological predisposition closely associated with depression is a pre-pathological trait, such as depressive temperament. The exposure to stressful life events in adulthood is an important trigger for the occurrence of clinically significant depressive episodes. However, these factors do not work alone, emphasizing the interaction between genetics and the environment or stressors, and the point at which such interactions occur, has a significant impact on the development of depression.
Because the etiology of depression is very diverse and not well defined so far, the currently accepted treatment of depression is mainly divided into three categories: 1. drug treatment; 2. psychotherapy; 3. and (4) physical therapy.
Firstly, the drug therapy mainly comprises the following steps: drug therapy is the primary treatment for depression episodes above moderate. The current first-line clinical antidepressants mainly comprise selective 5-hydroxytryptamine reuptake inhibitors (SSRI, which represents medicines of fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram and escitalopram), 5-hydroxytryptamine and norepinephrine reuptake inhibitors (SNRI, which represents medicines of venlafaxine and duloxetine), norepinephrine and specific 5-hydroxytryptamine antidepressants (NaSSA, which represents medicine of mirtazapine), and the like, while the traditional tricyclic and tetracyclic antidepressants and monoamine oxidase inhibitors have more adverse reactions, so that the application is obviously reduced in recent years.
Secondly, psychotherapy mainly refers to that psychotherapy is often combined with psychotherapy while drug therapy is performed on patients with depressive episodes with obvious psychosocial factors, and commonly used psychotherapy methods comprise supportive psychotherapy, cognitive behavior therapy, interpersonal therapy, marital and family therapy, psychokinetic therapy and the like, wherein the curative effect of the cognitive behavior therapy on the depressive episodes is well known.
Third, physical therapy, including electroshock, transcranial magnetic stimulation, vagal nerve stimulation, deep brain electrical stimulation, and neurofeedback therapy.
In general, the combination of medication and psychological therapy is the treatment of choice for most patients, while physical therapy is the more effective treatment.
There are 5 ways of treating depression with physical therapy:
1. electroshock therapy (ECT) is useful in treating major depressive patients, those with suicidal tendencies, confusion, stress, and those who have failed other therapies. The electric shock treatment is achieved by using mild anesthesia as incision and then using several brain electric shocks to generate curative effect. ECT is the most effective antidepressant therapy (ECT has therapeutic effect in 70% -90% of patients). The use of electroshock therapy has also been limited, for example, by the notorious implications associated with electroshock therapy and potential side effects of treatment, including affecting cardiovascular function and affecting cognitive function (e.g., temporary memory loss).
2. Transcranial Magnetic Stimulation (TMS) stimulates the brain with magnetic coils. Its therapeutic effect is recognized by the U.S. food and drug administration as being useful in treating mood disorders that are not effective against drugs. Transcranial magnetic stimulation requires daily treatment of the patient and is difficult to achieve for the average patient.
3. Vagal stimulation (VNS) is a relatively novel therapeutic technique that requires the implantation of an element in a patient to stimulate the vagus nerve (the vagus nerve is a mixed nerve of the autonomic nervous system in the human body). Vagal nerve stimulation may be used to treat depressed patients who are not effective with drugs. Data on the effectiveness of vagal stimulation is temporarily inadequate and VNS requires the implantation of medical components, possibly causing side effects that interfere with other medical components.
4. Deep Brain Stimulation (DBS) is an experimental treatment and has not been approved by the U.S. food and drug administration. DBS requires the implantation of components into the patient's brain to stimulate a portion of the brain known as the "25 region". There is little information on the effectiveness of DBS treatment. As an experimental treatment, DBS is only indicated for depressed patients who are not effective for other treatments, or for patients with no other treatment options.
5. Neurofeedback therapy aims at "retraining" the brain and modifying certain specific brain activity laws in depression patients. In recent years, neurofeedback therapy has also evolved into a new form of therapy using functional magnetic resonance imaging (fMRI). Neurofeedback treatment is costly and takes a significant amount of time. The range of most medicare coverage does not cover neurofeedback treatment.
At present, physical therapy has gained increasing acceptance: in foreign countries, developed countries have improved traditional ETC treatment, namely, intravenous anesthetics and muscle relaxants are added before the electroconvulsive treatment, so that convulsion of patients is obviously relieved and fear is avoided. TMS mainly achieves the treatment purpose through different frequencies, high frequency (>1Hz) is mainly an exciting effect, low frequency (< 1Hz) is an inhibiting effect, and due to the painless and non-traumatic physical characteristics, the long-term dream-virtual damage of the human brain to search the brain function and the high-level cognitive function is realized. Inspired by physical therapy, it is desirable to develop a new painless, non-invasive, green, more convenient and less expensive physical therapy.
Disclosure of Invention
The invention aims to overcome the defects of the prior art, and particularly discloses a treatment device for treating depression patients by electrically regulating and stimulating the tongue surface.
In order to achieve the technical purpose, the invention is realized according to the following technical scheme:
the invention discloses a treatment device for treating depression patients by electrically regulating and stimulating the surface of a tongue, which comprises a control circuit module and a tongue electrode body which are electrically connected with each other, wherein the tongue electrode body comprises a flexible circuit board, a plurality of discharge electrodes which are arranged in pairs are arranged on the flexible circuit board corresponding to the position of the oral cavity, external electrodes are arranged at the position corresponding to the outer side of the oral cavity, the discharge electrodes are connected with the external electrodes in a one-to-one correspondence manner, a plating layer and a packaging layer which expose a discharge electrode slice and the external electrodes are sequentially arranged on the periphery of the flexible circuit board from inside to outside, and the discharge electrodes are arranged in a distribution manner corresponding to the tip of the tongue, the left front side of the tongue, the right front side of the tongue, the left rear side of the tongue, the right rear side of the tongue.
As a further improvement of the above technology, the flexible circuit board includes a flexible substrate and a flexible circuit disposed on the flexible substrate, and the discharge electrode and the external electrode are connected to a terminal of the flexible circuit.
As a further improvement of the above technique, the flexible circuit is serpentine or linear.
As a further improvement of the above technique, the flexible substrate is made of Polyimide (PI) material to prevent leakage of copper.
As a further improvement of the technology, the plating layer is a gold plating layer, and the thickness range is more than or equal to 0.5 mu m.
As a further improvement of the above technique, the encapsulation layer is made of Parylene (Parylene).
As a further improvement of the technology, the discharge electrode or/and the external electrode is a sheet electrode, specifically, the discharge electrode or/and the external electrode is a square electrode sheet or a circular electrode sheet, and the side length or the diameter range value is 100 mu m-10 mm.
In the present invention, the discharge electrode and/or the external electrode may be a clamp-type electrode.
In the invention, the control circuit module comprises a control unit internal box, a butt joint electrode connected to the control unit internal box and an external power supply, wherein the control unit internal box is also provided with an adjusting switch and a current adjusting button for adjusting the butt joint electrode, the external power supply is a direct current power supply, the current range is 10 muA-10 mA, and the maximum voltage is 36V.
Compared with the prior art, the invention has the beneficial effects that:
(1) the treatment device for treating the depression patient by electrically controlling and stimulating the tongue surface comprises a tongue electrode body which can enter a cavity of a human body and is provided with a flexible circuit board (FPC), wherein the potential of certain parts of the tongue is controlled from low to high (the total intensity is 10 muA-10 mA) by corresponding to the electrical stimulation of different parts of the tongue of the human body, so that a plurality of areas including an amygdala in the brain can be activated to generate transmitters for inhibiting the generation of depression by using lower electric quantity (or stimulation) compared with other physical methods, and the stimulation can activate a plurality of areas including a frontal lobe cortex to generate excitation;
(2) according to the invention, the insulation packaging material Parylene (Parylene) with excellent protection performance and good biocompatibility is used for secondary packaging, and only the discharge electrode part and the external electrode part are exposed, so that the tongue electrode of the Flexible Printed Circuit (FPC) which can be placed in the mouth is obtained, and the Flexible Printed Circuit (FPC) has the characteristics of small side effect, low cost, simple and convenient use method and high effectiveness, has good biocompatibility, and provides ideal treatment for depression patients;
(3) according to the invention, the size of the tongue piece electrode can be adjusted according to the actual condition of a patient, and the tongue piece electrode can be replaced regularly, so that the tongue piece electrode is convenient and reliable to use and has good safety.
Drawings
The invention is described in detail below with reference to the following figures and specific embodiments:
FIG. 1 is a schematic diagram of a tongue electrode body according to the present invention;
FIG. 2 is a schematic diagram of a control module according to the present invention;
fig. 3 is a schematic view of the treatment apparatus of the present invention.
Detailed Description
As shown in fig. 1 to 3, the present invention discloses a therapeutic device for treating depression patients by electrically controlling and stimulating tongue surfaces, which includes a control circuit module 10 and a tongue electrode body 20 electrically connected to each other, wherein the tongue electrode body 20 includes a flexible circuit board 21, a plurality of discharge electrodes 22 arranged in pairs are disposed on the flexible circuit board 21 corresponding to the oral cavity side, external electrodes 23 are disposed on the flexible circuit board 21 corresponding to the oral cavity outside, each of the discharge electrodes includes a positive electrode and a negative electrode, the flexible circuit board 21 includes a flexible substrate 211 and a flexible circuit 212 disposed on the flexible substrate 211, the discharge electrodes 22 and the external electrodes 23 are connected to the end of the flexible circuit 21, and the discharge electrodes 22 and the external electrodes 23 are in one-to-one correspondence, so as to facilitate accurate control of power supply to each electrode at a later stage. The periphery of flexible circuit board is equipped with cladding material and the encapsulated layer that exposes discharge electrode and external electrode from inside to outside in proper order, discharge electrode 22 distributes and sets up corresponding to tongue point, the left front side of tongue, the right front side of tongue, the left rear side of tongue, the right rear side of tongue, tongue center, tongue root, owing to distribute discharge electrode 22 in the different positions of tongue shape substrate to ensure can be to the different regions of tongue 30 (tongue point, the left front side of tongue, the right front side of tongue, the left rear side of tongue, the right rear side of tongue, tongue center, tongue root) stimulate. In operation, it activates depression-producing neurotransmitters 50 in regions of the brain, including amygdala 40, by a lower electrical charge (or stimulus), and this stimulus activates the frontal cortex 60, and the brain's nerve center 70, in regions of the brain, to produce excitement.
In the present invention, the flexible circuit 212 has a serpentine shape or a straight shape, and the flexible substrate 211 is made of a Polyimide (PI) material.
In order to prevent the leakage of copper, the plating layer is a gold plating layer, the thickness range is more than or equal to 0.5 mu m, and the use safety of a human body is ensured.
The packaging layer is made of insulating packaging material Parylene (Parylene) with excellent protection performance and good biocompatibility, and the safety use performance of the packaging layer is greatly improved.
In the present embodiment, as shown in fig. 1, the discharge electrode 22 or/and the external electrode 23 is a sheet electrode, specifically, the discharge electrode 22 or/and the external electrode 23 is a square electrode sheet or a circular electrode sheet, and the length of the side or the diameter of the electrode sheet ranges from 100 μm to 10mm, which can be adjusted according to actual conditions.
Of course, in the present invention, the discharge electrode and/or the external electrode may be a clamp-type electrode, which is clamped at different parts of the tongue, and the form of the clamp may be various.
As shown in fig. 2, the control circuit module 10 includes a control unit internal box 11, a docking electrode 12 connected to the control unit internal box 11, and an external power supply 13, wherein the control unit internal box 11 is further provided with an adjusting switch 14 for adjusting the docking electrode 12, and a current adjusting button 15, the external power supply 13 is a dc power supply, the current range is 10 μ a to 10mA, and the maximum voltage is 36V.
In the invention, the tongue electrode body 10 is designed with a matched tongue sleeve according to the shape thereof, the tongue sleeve is made of hydrogel with good biocompatibility so as to fix the tongue electrode on the surface of the tongue gently, and the prepared tongue electrode and the tongue sleeve are stored in a clean vacuum tank.
When the tongue electrode body is used, the prepared tongue electrode body 20 is taken out of the vacuum tank, the assembled control circuit module 10 is connected with the external connection electrode 23 of the tongue electrode body 20, the tongue electrode body 20 is subjected to alcohol disinfection treatment, meanwhile, a patient cleans the oral cavity by using mouthwash or other modes, one side of the tongue electrode body 20 is placed in the oral cavity and corresponds to the tongue 30, and the tongue electrode body 20 is fixed by using a special tongue sleeve.
After the preparation work is finished, the external power supply 13 (provided with a direct current power supply, the current range is 10 muA-10 mA, the maximum voltage is 36V) part of the control circuit module 10 is turned on, when the preparation work is carried out, 100 muA current is firstly turned on to stimulate the tongue 30 of a patient, if the patient does not feel comfortable, the current is turned up by 10 muA, if the patient feels uncomfortable, the current is reduced by 10 muA, if the patient feels comfortable, the current is determined, the same point location method is also used for treatment when the treatment is repeated later, otherwise, 10 muA is continuously used as a step location adjustment until the patient feels comfortable. The size of the tongue electrode body 20 can be adjusted according to the actual condition of a patient, and the tongue electrode body 20 can be replaced periodically.
In the later stage, after the tongue piece is disinfected and the oral cavity is cleaned by the patient, the output electric signal can be set to be the obtained current value, and the treatment for a proper time is carried out regularly.
The control circuit module 10 can precisely control the electric signal output by the tongue electrode body 20, each area of the tongue 30 has different sensitivity to current, and a specific patient is tested again according to the experience result, if the patient feels too strong stimulation in the excitation area of the tongue (the body or the tongue feels uncomfortable), the current is properly reduced until the patient feels comfortable; if the patient feels the stimulation too weak in the excitation area of the tongue (the body or tongue does not feel any sensation or the comfort is not obvious), the current is properly adjusted to increase until the patient feels the illusion comfortable. And record the specific area to make the patient feel comfortable current.
There are multiple sites where the patient's tongue is stimulated to feel comfortable and different patients experience different levels of each site, so treatment will initially be adjusted adaptively for each patient, and the degree of effect of each tongue excitation on the patient is assessed (effect rating). Similar to example 3, the current test was performed by changing different tongue excitation areas, the degree of action of each current was evaluated at each point (extremely comfortable, more comfortable, slightly comfortable, no sensation, slightly uncomfortable, less comfortable, extremely uncomfortable, etc.), the corresponding adjustments were made to the test results and the details were recorded.
And sequencing and analyzing the results, and recording the test result which is considered to be most comfortable by the patient for reference data of long-term treatment in the later period. The patient is allowed to wear an 'electro-tongue stimulation device' and adjusted to the most comfortable potential of the patient, at which time the patient is subjected to functional magnetic resonance imaging (fMRI) equipment to verify the active region of the brain of the patient, and the effect of the method on the mood changes of the patient can be analyzed.
The present invention is not limited to the above-described embodiments, and various changes and modifications of the present invention are also intended to be included within the scope of the claims and equivalent technologies of the present invention, unless they depart from the spirit and scope of the present invention.

Claims (10)

1. A therapeutic device for treating a patient with depression through electrically controlled stimulation of a tongue surface, characterized by: including the control circuit module and the tongue piece electrode body of mutual electric connection, tongue piece electrode body includes flexible circuit board, is equipped with a plurality of discharge electrode of arranging in pairs corresponding to oral cavity side position on flexible circuit board, is equipped with external electrode corresponding to oral cavity outside position, and discharge electrode and external electrode one-to-one connection, the periphery of flexible circuit board is equipped with cladding material and the encapsulation layer that exposes discharge electrode and external electrode from inside to outside in proper order, discharge electrode is corresponding to tongue point, the left front side of tongue, the right front side of tongue, the left rear side of tongue, the right rear side of tongue, tongue center, tongue root distribution setting.
2. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the flexible circuit board comprises a flexible substrate and a flexible circuit arranged on the flexible substrate, and the discharge electrode and the external electrode are connected to the tail end of the flexible circuit.
3. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 2, wherein: the flexible circuit is serpentine or linear.
4. The therapeutic device for the treatment of patients with depression by electrically controlled stimulation of the tongue surface according to claim 1 or 2, characterized in that: the flexible substrate is made of a Polyimide (PI) material.
5. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the plating layer is a gold plating layer, and the thickness range is more than or equal to 0.5 mu m.
6. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the packaging layer is made of Parylene (Parylene).
7. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the discharge electrode or/and the external electrode are/is a sheet electrode.
8. The therapeutic device for treating a patient with depression by electrically controlled stimulation of the tongue surface according to claim 5, wherein: the discharge electrode or/and the external electrode is a square electrode plate or a circular electrode plate, and the side length or diameter range value is 100 mu m-10 mm.
9. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the discharge electrode or/and the external electrode are/is a clamp type electrode.
10. The therapeutic device for treating a patient with depression through electrically controlled stimulation of the tongue surface according to claim 1, wherein: the control circuit module comprises a control unit internal box, a butt joint electrode connected to the control unit internal box and an external power supply, wherein the control unit internal box is also provided with an adjusting switch and a current adjusting button for adjusting the butt joint electrode, the external power supply is a direct current power supply, the current range is 10 muA-10 mA, and the maximum voltage is 36V.
CN201911112824.7A 2019-11-14 2019-11-14 Treatment device for treating depression patients through electrically controlled stimulation of tongue surface Pending CN110772717A (en)

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Publication number Priority date Publication date Assignee Title
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US20160175585A1 (en) * 2014-12-18 2016-06-23 Daniel T. Gregory Transcutaneous neural stimulation device
US20170232252A1 (en) * 2014-04-03 2017-08-17 Colorado State University Research Foundation Tongue stimulation for communication of information to a user

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130072999A1 (en) * 2009-10-20 2013-03-21 Nyxoah SA Systems and Methods for Determining a Sleep Disorder Based on Positioning of the Tongue
CN104053472A (en) * 2011-09-30 2014-09-17 尼科索亚股份有限公司 System and method for nerve modulation using noncontacting electrodes
US20170232252A1 (en) * 2014-04-03 2017-08-17 Colorado State University Research Foundation Tongue stimulation for communication of information to a user
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