• 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.

• Korean Journal of Clinical Laboratory Science
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• v.51 no.4
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• pp.468-474
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• 2019

Deep brain stimulation (DBS) is an effective surgical procedure for treating drug refractory movement disorders, and DBS involves delivering high frequency electrical stimulation to deep brain nuclei. Microelectrode recording (MER) is a complementary test that can precisely identify the location of deep brain nuclei, along with MRI correlation, during DBS surgery to improve the surgical outcome and minimize side effects. The purpose of this paper is to analyze the neuro-physiological waveforms and identify the usefulness of MER by analyzing the MER performed during DBS surgery for treating movement disorders. We retrospectively reviewed 28 patients who underwent MER during DBS surgery for movement disorders from January to December 2018. Of the 28 patients, 38 MERs for the subthalamic nucleus (STN), 10 MERs for the globuspallidusinternus (Gpi), and 4 MERs for the ventral intermediate thalamic nucleus (VIM) were performed. In all the cases, the target sites were found and micro-stimulations were used to check for side effects and to readjust the target sites. The clinical symptoms of all 28 patients improved after surgery. In conclusion, MER is a useful test that employs neuro-physiological waveforms to accurately identify the deep brain nuclei, along with MRI correlation, to improve the DBS surgical outcomes for movement disorders and to minimize side effects.

• Journal of the Korean Society for Precision Engineering
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• v.29 no.9
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• pp.1035-1040
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• 2012

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) has been found to be effective treatment of Parkinson's disease (PD). This study aims to evaluate the effect of DBS for rigidity during DBS surgery. Six Parkinsonian patients who received STN-DBS surgery participated in this study. The examiner imposed flexion and extension of a patient's wrist randomly. Resistance to passive movement was quantified by viscoelastic properties (two damping constants for each of flexion and extension phase and one spring constant throughout both phases). All Viscoelastic constants decreased by DBS (p<0.01). Specifically, reduction in damping constant during flexion ($B_f$) was greater than those of damping constant during extension ($B_e$) and of spring constant (p<0.05). $B_f$ would be appropriate for evaluation of effect of DBS for rigidity during DBS surgery.

• Journal of the Korean Society of Radiology
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• v.13 no.7
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• pp.901-907
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• 2019

The aim of this study is to evaluate the ability of target localizations of Leksell GammaPlan(LGP) in Gamma Knife Subthalamotomy(or Pallidotomy, Thalamotomy) of functional diseases. To evaluate the accuracy of LGP's location settings, the difference Δr of the target coordinates calculated by LGP (or LSP) and author's algorithm was reviewed for 10 patients who underwent Deep Brain Stimulation(DBS) surgery. Δr ranged from 0.0244663 mm to 0.107961 mm. The average of Δr was 0.054398 mm. Transformation matrix between stereotactic space and brain atlas space was calculated using PseudoInverse or Singular Value Decomposition of Mathematica to determine the positional relationship between two coordinate systems. Despite the precise frame positioning, the misalignment of yaw from -3.44739 degree to 1.82243 degree, pitch from -4.57212 degree to 0.692063 degree, and rolls from -6.38239 degree to 7.21426 degree appeared. In conclusion, a simple in-house algorithm was used to test the accuracy for location settings of LGP(or LSP) in Gamma Knife platform and the possibility for Gamma Knife Subthalamotomy. The functional diseases can be treated with Gamma Knife Radiosurgery with safety and efficacy. In the future, the proposed algorithm for target localizations' QA will be a great contributor to movement disorders' treatment of several Gamma Knife Centers.

• 재활복지
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• v.18 no.4
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• pp.237-255
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• 2014

Idiopathic Parkinson disease(IPD) is an neurodegenerative disease caused by the loss of dopamine cells in the substantia nigra, a region of midbrain. Its major symptoms are muscular rigidity, bradykinesia, resting tremor, and postural instability. An estimated 70~90% of patients with IPD also have hypokinetic dysarthria. Subthalamic nucleus deep brain stimulation (STN-DBS) has been reported to be successful in relieving the core motor symptoms of IPD in the advanced stages of the disease. However, data on the effects of STN-DBS on speech performance are inconsistent. A medline literature search was done to retrieve articles published from 1987 to 2012. The results were narrowed down to focus on speech performance under STN-DBS based perceptual, acoustic, and/or aerodynamic analyses. Among the 32 publications which dealt with speech performance after STN-DBS indicated improvement(42%), deterioration(29%), mixed results(26%), or no change(3%). The most favorite method was found to be based upon acoustic analysis by using a vowel prolongation and Unified Parkinson's Disease Rating Scale(UPDRS). For the purpose of verifying the effect of the STN-DBS, speech evaluation should be undertaken on all speech components such as articulation, resonance, phonation, respiration, and prosody by using a contextual speech task.

• The Journal of the Acoustical Society of Korea
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• v.42 no.5
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• pp.412-421
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• 2023

Ultrasound brain stimulation is spot-lighted by its capability of inducing brain cell activation in a localized deep brain region and ultimately treating impaired brain function while the efficiency and directivity of neural modulation are highly dependent on types of stimulus waveforms. Therefore, to optimize the types of stimulation parameters, we propose a cell-cultivable ultrasonic transducer having a series stack of a spin-coated polymer piezoelectric element (Poly-vinylidene fluoride-trifluorethylene, PVDF-TrFE) and a parylene insulating layer enhancing output acoustic pressure on a glass-coverslip which is commonly used in culturing cells. Due to the uniformity and high accuracy of stimulus waveform, tens of neuronal cell responses located on the transducer surface can be recorded simultaneously with fluorescence microscopy. By averaging the cell response traces from tens of cells, small changes to the low intensity ultrasound stimulations can be identified. In addition, the reduction of stimulus distortions made by standing wave generated from reflections between the transducers and other strong reflectors can be achieved by placing acoustic absorbers. Through the proposed ultrasound transducer, we could successfully observe the calcium responses induced by low-intensity ultrasound stimulation of 6 MHz, 0.2 MPa in astrocytes cultured on the transducer surface.

• 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.

• Journal of Radiation Industry
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• v.11 no.3
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• pp.139-144
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• 2017

To evaluation of clinical usefulness for B1+RMS limits, we compared image quality of Routine, Specific absorption rate (SAR) and Root mean square (RMS) protocol. 5 volunteers underwent Magnetic Resonance Imaging (MRI) scan of the brain using three different protocols. We draw Region of interest ROI in cortex, white matter, gray matter, putamen and thalamus of axial plan. Signal to noise ratio (SNR) were evaluated in each area and Contrast to noise ration (CNR) were evaluated between white matter and gray matter. Qualitative evaluation was used to score each ROI. B1+RMS is confirmed its usefulness compared to conventional SAR standard on the aspect of improvement of image quality, reduction of scan time and easy adjusting parameter.

• Journal of the Korean Society for Precision Engineering
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• v.30 no.5
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• pp.559-563
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• 2013

This study aims to quantify the effects of medication (Med) and deep brain stimulation (DBS) on resting rigidity in patients with Parkinson's disease. We tested 10 limbs of five patients under each of four treatment conditions: 1) baseline, 2) DBS, 3) Med, 4) DBS + Med. Rigidity at the wrist joint was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). The examiner randomly imposed flexion and extension movement on patient's wrist joint. Resistance to passive movement was quantified by viscoelastic properties. Not only rigidity score but also damping constant showed improvements in rigidity by DBS and Med treatments (p<0.05). This indicates that the viscosity can represent the change in rigidity due to DBS as well as Med, which was manifested by UPDRS score.

• Journal of Korean Neurosurgical Society
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• v.37 no.2
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• pp.112-115
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• 2005

Objective: Thalamic lesioning and deep brain stimulation(DBS) have proved to be beneficial to the treatment of essential tremor(ET). The authors compared the effects and complications of two modalities. Methods: A total of 34 patients with ET were treated with ventral intermediate(Vim) nucleus thalamotomy or Vim DBS from May 1999 to May 2003. The procedure of lesioning or stimulation were performed as usual manner with or without microelectrode recording. Postoperatively, utilizing the various combinations of frequency, voltage and pulse width optimized the stimulation. The degree of improvements of tremor and the occurrence of the complications were evaluated postoperatively and at follow-up. Results: There were 38 procedures, including 27 with Vim thalamotomy and 11 with DBS, in 34 patients. Of the thalamotomy group, left Vim lesioning is 25 and right one is 2. Follow-up duration ranged from 12 to 57 months. In the thalamotomy group, the rate of overall good outcome was 88.9% but 12 patients (44.4%) showed permanent adverse effects. In the cases of stimulation, the rate of overall good outcome was 90.9% and two patients had acceptable dysarthria. Conclusion: Both Vim thalamotomy and Vim DBS were effective for the treatment of ET, although perioperative adverse effects tended to be higher in patients who had thalamotomy. In cases of DBS, adjustments of stimulation parameters enabled an acceptable position to be achieved with tremor control and unwanted effects.