• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.119-139
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• 2022

Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

• Sleep Medicine and Psychophysiology
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• v.28 no.2
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• pp.53-69
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• 2021

Sleep disorders, increasingly prevalent in the general population, induce impairment in daytime functioning and other clinical problems. As changes in cortical excitability have been reported as potential pathophysiological mechanisms underlying sleep disorders, multiple studies have explored clinical effects of modulating cortical excitability through non-invasive brain stimulation in treating sleep disorders. In this study, we critically reviewed clinical studies using non-invasive brain stimulation, particularly transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS), for treatment of sleep disorders. Previous studies have reported inconsistent therapeutic effects of TMS and tDCS for various kinds of sleep disorders. Specifically, low-frequency repetitive TMS (rTMS) and cathodal tDCS, both of which exert an inhibitory effect on cortical excitability, have shown inconsistent therapeutic effects for insomnia. On the other hand, high-frequency rTMS and anodal tDCS, both of which facilitate cortical excitability, have improved the symptoms of hypersomnia. In studies of restless legs syndrome, high-frequency rTMS and anodal tDCS induced inconsistent therapeutic effects. Single TMS and rTMS have shown differential therapeutic effects for obstructive sleep apnea. These inconsistent findings indicate that the distinctive characteristics of each non-invasive brain stimulation method and specific pathophysiological mechanisms underlying particular sleep disorders should be considered in an integrated manner for treatment of various sleep disorders. Future studies are needed to provide optimized TMS and tDCS protocols for each sleep disorder, considering distinctive effects of non-invasive brain stimulation and pathophysiology of each sleep disorder.

• Proceedings of the KAIS Fall Conference
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• 2011.12a
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• pp.244-247
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• 2011

Transcranial Magnetic Stimulation(TMS) Navigation System은 자기 자극을 이용한 비 침습적 방법으로 통증 없이 뇌 기능의 활성화 및 재활에 필요한 자극, 자극의 위치, 환자의 모션 등을 3차원 뇌영상에 제공한다. 이 시스템에서 사용되는 소프트웨어는 Talairach 좌표를 적용하여 재구성된 MR 영상을 3차원으로 제공하며, 이를 이용하여 자극의 위치를 표시할 수 있는 기준을 제공한다. 또한 환자의 모션이나 자극 트랜스듀서의 위치를 Talairach 좌표 매핑 소프트웨어 제공하기위해 스테레오 카메라를 이용하여 정확한 좌표를 획득할 수 있는 알고리즘을 적용하였다. 이러한 시스템 개발을 통해 뇌질환 연구와 치료에 다양하게 활용될 수 있을 것으로 기대된다.

• Korean Journal of Acupuncture
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• v.30 no.2
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• pp.135-142
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• 2013

Objectives : This study aimed to investigate the general effects of low-frequency electrical stimulation of the ankle joint acupuncture points(BL62 and KI6) on the brain waves of elderly women as a pilot study to figure out the possibility of candidate non-invasive and non-chemical stimulation method for the enhancing the brain function. Methods : A randomized, controlled, double-blinded clinical trial was performed in 31 healthy women(mean age, 54.5 years) within a treatment duration of 12 sessions. In the experimental group, low-frequency electrical stimulation was applied using the maximum range of the individual insensible strength(mean current, $0.04{\mu}A$). The control group received sham stimulation. The background electroencephalographic activity was measured before and after the12 sessions. Results : After 12 sessions of stimulation, the relative power of the alpha wave increased(32 of 32 channels: significant difference in 11 channels, p<0.05); the theta(30 of 32 channels: significant difference in 10 channels, p<0.05), beta(31 of 32 channels), and gamma(30 of 32 channels: significant difference in 7 channels, p<0.05) powers were also decreased compared with the sham group. Conclusions : Electrical stimulation on the ankle joint acupuncture points(BL62 and KI6) seemed to stabilize the elderly women brain by inducing the alpha power and reducing beta, theta, and gamma powers. These results provide insight into the action mechanism of the stimulation and can assist the future developement of a non-invasive and non-chemical treatment technique for stressor related cognitive problems.

• Korean Journal of Biological Psychiatry
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• v.24 no.3
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• pp.95-109
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• 2017

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique which can change cortical excitability in targeted area by producing magnetic field pulses with an electromagnetic coil. rTMS treatment has been used to treat various neuropsychiatric disorders including depression. In this review, we evaluate the literature on rTMS for depression by assessing its efficacy on different subtypes of depression and different technical parameters. In particular, we focus on the results of randomized clinical trials and meta-analyses for depression after the US Food and Drug Administration approval in 2008, which acknowledged its efficacy and acceptability. We also review the new forms of rTMS therapy including deep TMS, theta-burst stimulation, and magnetic seizure therapy (MST) that have been under recent investigation. High frequency rTMS over left dorsolateral prefrontal cortex (DLPFC), low frequency rTMS over right DLPFC, or bilateral rTMS is shown to be effective and acceptable in treatment for patients with non-psychotic, unipolar depression either as monotherapy or adjuvant. Deep TMS, theta-burst stimulation and MST are promising new TMS techniques which warrant further research.

• The Korean Society of Law and Medicine
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• v.24 no.2
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• pp.147-196
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• 2023

Advances in brain science have made it possible to stimulate the brain to treat brain disorder or to connect directly between the neuron activity and an external devices. Non-invasive neurotechnologies already exist, but invasive neurotechnologies can provide more precise stimulation or measure brainwaves more precisely. Nowadays deep brain stimulation (DBS) is recognized as an accepted treatment for Parkinson's disease and essential tremor. In addition DBS has shown a certain positive effect in patients with Alzheimer's disease and depression. Brain-computer interfaces (BCI) are in the clinical stage but help patients in vegetative state can communicate or support rehabilitation for nerve-damaged people. The issue is that the people who need these invasive neurotechnologies are those whose capacity to consent is impaired or who are unable to communicate due to disease or nerve damage, while DBS and BCI operations are highly invasive and require informed consent of patients. Especially in areas where neurotechnology is still in clinical trials, the risks are greater and the benefits are uncertain, so more explanation should be provided to let patients make an informed decision. If the patient is under guardianship, the guardian is able to substitute for the patient's consent, if necessary with the authorization of court. If the patient is not under guardianship and the patient's capacity to consent is impaired or he is unable to express the consent, korean healthcare institution tend to rely on the patient's near relative guardian(de facto guardian) to give consent. But the concept of a de facto guardian is not provided by our civil law system. In the long run, it would be more appropriate to provide that a patient's spouse or next of kin may be authorized to give consent for the patient, if he or she is neither under guardianship nor appointed enduring power of attorney. If the patient was not properly informed of the risks involved in the neurosurgery, he or she may be entitled to compensation of intangible damages. If there is a causal relation between the malpractice and the side effects, the patient may also be able to recover damages for those side effects. In addition, both BCI and DBS involve the implantation of electrodes or microchips in the brain, which are controlled by an external devices. Since implantable medical devices are subject to product liability laws, the patient may be able to sue the manufacturer for damages if the defect caused the adverse effects. Recently, Korea's medical device regulation mandated liability insurance system for implantable medical devices to strengthen consumer protection.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.209-244
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• 2020

TMS and tDCS are non-invasive devices that treat the diseases of patients or individual users, and manage or improve their health by applying stimulation to a brain through magnetism and electricity. The effect and safety of these devices have proved to be valid in several diseases, but research in this area is still much going on. Despite increasing cases of their application, legislations directly regulating TMS and tDCS are hard to find. Legal regulation regarding TMS and tDCS in the United States, Germany and Japan reveals that while TMS has been approved as a medical device with a moderate risk, tDCS has not yet earned approval as a medical device. However, the recent FDA guidance, European MDR changes, recalls in the US, and relevant legal provisions of Germany and Japan, as well as recommendations from expert groups all show signs of tDCS growing closer to getting approved as a medical device. Of course, safety and efficacy of tDCS can still be regulated as a general product instead of as a medical device. Considering multiple potential impacts on a human brain, however, the need for independent regulation is urgent. South Korea also lacks legal provisions explicitly regulating TMS and tDCS, but they fall into the category of the grade 3 medical devices according to the notifications of the Korean Ministry of Food and Drug Safety. And safety and efficacy of TMS are to be evaluated in compliance with the US FDA guidance. But no specific guidelines exist for tDCS yet. Given that tDCS devices are used in some hospitals in reality, and also at home by individual buyers, such a regulatory gap must quickly be addressed. In a longer term, legal system needs to be in place capable of independently regulating non-invasive brain stimulating devices.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.14 no.5
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• pp.403-412
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• 2021

Alzheimer's disease (AD) is the most common cause of dementia, showing progressive neurodegeneration. Although oral medications for symptomatic improvement still take a huge part of treatment, there are several limitations caused by pharmacology-based real world clinic. In this respect, non-pharmacologic treatment for AD is rising to prominence. Transcranial direct current stimulation (tDCS) is a one of the non-invasive neuromodulation technique, using low-voltage direct current. In terms of safety, tDCS already has been proven through numerous previous reports. This review focused on behavioral, neurophysiologic and histopathologic improvement by applying tDCS in AD rodent models, thereby suggesting reliable background evidence for human-based tDCS study.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.12 no.4
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• pp.413-418
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• 2019

Studies are now actively underway to confirm the degree of treatment and rehabilitation of patients with brain-related diseases (dementia, schizophrenia, depression, Parkinson's disease). Among them, Transcranial magnetic stimulation (TMS) is widely used in treatment because it is a technique that is used for noninvasive brain neuron control in patients with brain disorders. It can be seen that muscle fatigue of normal people increases during Transcranial magnetic stimulation. Therefore, in this paper, our purpose is to build an EMG measurement system to measure motor neuron-induced response during transcranial magnetic stimulation and We identify a motor-neutral response system using tendency in the RMS graph. As an experimental method, the Raw Data received through the surface EMG device and analyzed by RMS technique, after the contraction and relaxation movement of the biceps brachii. As a result of the experiment, we confirmed the trend of rising RMS graph, and it will can be used to determine the self-stimulation intensity for each individual in consideration of the data of the motor-neutral response.

• Clinical and Experimental Pediatrics
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• v.49 no.5
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• pp.558-564
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• 2006

Purpose : Transcranial electromagnetic stimulation(TMS) is a noninvasive method which stimulates the central nervous system through pulsed magnetic fields without direct effect on the neurons. Although the neurobiologic mechanisms of magnetic stimulation are unknown, the effects on the brain are variable according to the diverse stimulation protocols. This study aims to observe the effect of the magnetic stimulation with two different stimulation methods on the cultured hippocampal slices. Methods : We obtained brains from 8-days-old Spague-Dawley rats and dissected the hippocampal tissue under the microscope. Then we chopped the tissue into 450 µm thickness slices and cultured the hippocampal tissue by Stoppini's method. We divided the inserts, which contained five healthy cultured hippocampal slices respectively, into magnetic stimulation groups and a control group. To compare the different effects according to the frequency of magnetic stimulation, stimulation was done every three days from five days in vitro at 0.67 Hz in the low stimulation group and at 50 Hz in the high stimulation group. After N-methyl-D-aspartate exposure to the hippocampal slices at 14 days in vitro, magnetic stimulation was done every three days in one and was not done in another group. To evaluate the neuronal activity after magnetic stimulation, the $NeuN/{\beta}$-actin ratio was calculated after western blotting in each group. Results : The expression of NeuN in the magnetic stimulation group was stronger than that of the control group, especially in the high frequency stimulation group. After N-methyl-D-aspartate exposure to hippocampal slices, the expression of NeuN in the magnetic stimulation group was similar to that of the control group, whereas the expression in the magnetic non-stimulation group was lower than that of the control group. Conclusion : We suggest that magnetic stimulation increases the neuronal activity in cultured hippocamal slices, in proportion to the stimulating frequency, and has a neuroprotective effect on neuronal damage.