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Non-invasive Brain Stimulation and its Legal Regulation - Devices using Techniques of TMS and tDCS - (비침습적 뇌자극기술과 법적 규제 - TMS와 tDCS기술을 이용한 기기를 중심으로 -)

  • Choi, Min-Young
    • 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.

Deoxypodophyllotoxin Induces a Th1 Response and Enhances the Antitumor Efficacy of a Dendritic Cell-based Vaccine

  • Lee, Jun-Sik;Kim, Dae-Hyun;Lee, Chang-Min;Ha, Tae-Kwun;Noh, Kyung-Tae;Park, Jin-Wook;Heo, Deok-Rim;Son, Kwang-Hee;Jung, In-Duk;Lee, Eun-Kyung;Shin, Yong-Kyoo;Ahn, Soon-Cheol;Park, Yeong-Min
    • IMMUNE NETWORK
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    • v.11 no.1
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    • pp.79-94
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    • 2011
  • Background: Dendritic cell (DC)-based vaccines are currently being evaluated as a novel strategy for tumor vaccination and immunotherapy. However, inducing long-term regression in established tumor-implanted mice is difficult. Here, we show that deoxypohophyllotoxin (DPT) induces maturation and activation of bone marrow-derived DCs via Toll-like receptor (TLR) 4 activation of MAPK and NF-${\kappa}B$. Methods: The phenotypic and functional maturation of DPT-treated DCs was assessed by flow cytometric analysis and cytokine production, respectively. DPT-treated DCs was also used for mixed leukocyte reaction to evaluate T cell-priming capacity and for tumor regression against melanoma. Results: DPT promoted the activation of $CD8^+$ T cells and the Th1 immune response by inducing IL-12 production in DCs. In a B16F10 melanoma-implanted mouse model, we demonstrated that DPT-treated DCs (DPT-DCs) enhance immune priming and regression of an established tumor in vivo. Furthermore, migration of DPT-DCs to the draining lymph nodes was induced via CCR7 upregulation. Mice that received DPT-DCs displayed enhanced antitumor therapeutic efficacy, which was associated with increased IFN-${\gamma}$ production and induction of cytotoxic T lymphocyte activity. Conclusion: These findings strongly suggest that the adjuvant effect of DPT in DC vaccination is associated with the polarization of T effector cells toward a Th1 phenotype and provides a potential therapeutic antitumor immunity.

Effect of tDCS on Cognitive Function of Patients With Stroke: A Systematic Review and Meta-Analysis (뇌졸중 후 인지장애에 대한 경두개 직류 자극: 체계적 고찰 및 메타분석)

  • Yang, Min Ah;Won, Kyung-A;Park, Hae Yean;Park, Ji-Hyuk
    • Therapeutic Science for Rehabilitation
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    • v.10 no.2
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    • pp.7-22
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    • 2021
  • Objective : This study aimed to analyze the effect of transcranial direct current stimulation (tDCS) on cognitive function recovery in patients with stroke. Methods : Data published in Korean and foreign academic journals from 2009 to 2019 were searched using the NDSL, RISS, PubMed, and CINAHL databases. A total of 11 experimental research articles were selected based on the inclusion and exclusion criteria. A qualitative assessment was conducted, and a meta-analysis of nine results from seven of the stuides was performed using the Comprehensive Meta-Analysis 3.0 program. Results : Based on the results of the meta-analysis, the attention and memory effect sizes were 0.725 and 0.796, respectively, which were both considered a "medium effect size". Statistically significant changes were observed in both the areas (p<0.05). Conclusion : The results of this study confirmed that tDCS can be useful in the rehabilitation of patients with stroke with limited cognitive function. In addition, the application methods differed, indicating that a formalized tDCS protocol is required.

The Effects of Convergent Stimulation on tDCS during Mirror Therapy to Improve the Muscle Strength and Gait Ability in Chronic Stroke Patients (만성 뇌졸중 환자에서 거울 치료 시 tDCS의 융합 자극이 다리근력 및 보행능력에 미치는 효과)

  • Lee, Seung-Tae;Kim, Kyung-Yoon
    • Journal of Industrial Convergence
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    • v.18 no.4
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    • pp.51-59
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    • 2020
  • The purpose of this study was to investigate the improvement of muscle strength and gait ability of paralyzed lower extremity through convergent stimulation of tDCS(transcranial direct current stimulation) during mirror therapy with resistance exercise in chronic stroke patients. 12 patients with stroke were randomly assigned and divided into groupI(n=6) and groupII(n=6). GroupI provided NDT(neurodevelopmental treatment) and mirror therapy with sham tDCS, and groupII provided NDT and mirror therapy with tDCS. Each convergent stimulation was conducted 5 times a week, 30 minutes per session for a total of 4 weeks. All evaluation was conducted before intervention and performed after 4 weeks. Lower extremity strength showed a significant improvement in groupII compared to groupI(p<.05), and in comparison between groups by variance, significant difference in the quadriceps(p<.01) and tibialis anterior(p<.01). Gait ability showed a significant improvement in both groupI(p<.05) and groupII(p<.05), and significant difference in comparison between groups by variance(p<.01). In conclusion, mirror therapy with tDCS convergent stimulation had a positive improvement effect on paralyzed lower extremity to strength and gait ability through the overlapping interaction.

Improved CS-RANSAC Algorithm Using K-Means Clustering (K-Means 클러스터링을 적용한 향상된 CS-RANSAC 알고리즘)

  • Ko, Seunghyun;Yoon, Ui-Nyoung;Alikhanov, Jumabek;Jo, Geun-Sik
    • KIPS Transactions on Software and Data Engineering
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    • v.6 no.6
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    • pp.315-320
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    • 2017
  • Estimating the correct pose of augmented objects on the real camera view efficiently is one of the most important questions in image tracking area. In computer vision, Homography is used for camera pose estimation in augmented reality system with markerless. To estimating Homography, several algorithm like SURF features which extracted from images are used. Based on extracted features, Homography is estimated. For this purpose, RANSAC algorithm is well used to estimate homography and DCS-RANSAC algorithm is researched which apply constraints dynamically based on Constraint Satisfaction Problem to improve performance. In DCS-RANSAC, however, the dataset is based on pattern of feature distribution of images manually, so this algorithm cannot classify the input image, pattern of feature distribution is not recognized in DCS-RANSAC algorithm, which lead to reduce it's performance. To improve this problem, we suggest the KCS-RANSAC algorithm using K-means clustering in CS-RANSAC to cluster the images automatically based on pattern of feature distribution and apply constraints to each image groups. The suggested algorithm cluster the images automatically and apply the constraints to each clustered image groups. The experiment result shows that our KCS-RANSAC algorithm outperformed the DCS-RANSAC algorithm in terms of speed, accuracy, and inlier rate.

Effect of tDCS Stimulation for Improving Working Memory on Stroke Patients' EEG Variation (작업기억의 향상을 위한 tDCS 자극이 뇌졸중 환자의 뇌파변화에 미치는 영향)

  • Bae, Si-Jeol;Jeong, Woo-Sik;Lee, Hong-Gyun;Kim, Kyung-Yoon
    • The Journal of the Korea Contents Association
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    • v.12 no.7
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    • pp.261-272
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    • 2012
  • This study was conducted so as to examine which change tDCS (Transcranial Direct Current Stimulation) for improving working memory can make on the EEC of stroke patients. Among the patients who suffered for more than 6 months by hemiparalysis caused by stroke, 20 patients selected by MMSE and DST were randomly divided into I group (10 patients) fulfilled by only CCT and II group (10 patients) fulfilled by both tDCS and CCT for total 4 weeks, 30 minutes per a day, three times per a week. For examining EEC variation, the absolute spectrum power was calculated by three bands (${\theta}$; 4~8 Hz, lower ${\alpha}$; 8~10.5 Hz, upper ${\alpha}$;10.5~13 Hz) during the task of words, photos and mental calculation with EEC test, before the arbitration, after 2 weeks and after 4 weeks, so the rate of increase and decrease (%) for the reference EEC was obtained. As the results, the first, particular aspects different one another in three bands were detected according to the measuring period and task. The second, in the forth week, there was only a significant difference in lower ${\alpha}$-power of all tasks. Therefore, through the procedure measuring EEC of this study, the degree of working memory's damage can be expressed by numerical value and tDCS should be additionally helpful for brain damaged patients' perception rehabilitation.

The Effect of Gefitinib on Immune Response of Human Peripheral Blood Monocyte-Derived Dendritic Cells (인간 말초혈액 단핵구 유래 수지상세포의 면역반응에 미치는 Gefitinib의 영향)

  • Cho, Jin-Hoon;Kim, Mi-Hyun;Lee, Kwang-Ha;Kim, Ki-Uk;Jeon, Doo-Soo;Park, Hye-Kyung;Kim, Yun-Seong;Lee, Min-Ki;Park, Soon-Kew
    • Tuberculosis and Respiratory Diseases
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    • v.69 no.6
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    • pp.456-464
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    • 2010
  • Background: Synergistic antitumor effects of the combined chemoimmunotherapy based on dendritic cells have been reported recently. The aim of this study is to search new applicability of gefitinib into the combination treatment through the confirmation of gefitinib effects on the monocyte derived dendritic cells (moDCs); most potent antigen presenting cell (APC). Methods: Immature and mature monocyte-derived dendritic cell (im, mMoDC)s were generated from peripheral blood monocyte (PBMC) in Opti-MEM culture medium supplemented with IL-4, GM-CSF and cocktail, consisting of TNF-${\alpha}$ (10 ng/mL), IL-$1{\beta}$ (10 ng/mL), IL-6 (1,000 U/mL) and $PGE_2$ ($1{\mu}/mL$). Various concentrations of gefitinib also added on day 6 to see the influence on immature and mature MoDCs. Immunophenotyping of DCs under the gefitinib was performed by using monoclonal antibodies (CD14, CD80, CD83, CD86, HLA-ABC, HLA-DR). Supernatant IL-12 production and apoptosis of DCs was evaluated. And MLR assay with $[^3H]$-thymidine uptake assay was done. Results: Expression of CD83, MHC I were decreased in mMoDCs and MHC I was decreased in imMoDCs under gefitinib. IL-12 production from mMoDCs was decreased under $10{\mu}M$ of gefitinib sinificantly. Differences of T cell proliferation capacity were not observed in each concentration of geftinib. Conclusion: In spite of decreased expressions of some dendritic cell surface molecules and IL-12 production under $10{\mu}M$ of gefitinib, significant negative influences of gefitinib in antigen presenting capacity and T cell stimulation were not observed.

Effects of Acute Transcranial Direct Current Stimulation on Muscle Endurance of the Lower Extremities for Young Healthy Adults (일회성 경두개 직류전기자극(tDCS) 적용이 젊은 성인의 하지 근지구력에 미치는 영향)

  • Park, Shin-Young;Ko, Do-Kyung;Jeong, Hyeong Do;Lee, Hanall;Lee, Hyungwoo;Kim, Chanki;An, Seungho;Kim, Jiyoung;Moon, Bosung;Son, Jee-Soo;Lee, Dohyeon;Lee, Eui-Young;Lee, Ju Hak;Im, Seungbin;Tan, Yuan;Jeon, Kyoungkyu;Kang, Nyeonju
    • Korean Journal of Applied Biomechanics
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    • v.32 no.3
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    • pp.94-102
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    • 2022
  • Objective: The purpose of this study was to investigate the effect of acute transcranial direct current stimulation (tDCS) on the isokinetic muscular endurance of the lower extremity for young adults. Method: Thirteen young adults performed isokinetic fatigue tasks for two experimental conditions including real tDCS and sham stimulation protocols. Before and after the task, the tensiomyography was used for evaluating muscle contraction characteristics of vastus medialis and semitendinosus. Paired t-test was performed to compare the fatigue index, changes in maximum radial displacement (∆Dm), delay time (∆Tc), and velocity of contraction (∆Vc) between tDCS conditions. Results: We found no significant differences in the fatigue index between real and sham conditions. In addition, the analyses identified no significant different values of ∆Dm, ∆Tc, and ∆Vc in the vastus medialis and semitendinosus between real and sham conditions. Conclusion: These findings suggest that the tDCS protocols may have no acute effect on lower limb muscle endurance for young adults. Future studies should consider the long-term effects of repetitive tDCS sessions, various stimulation positions, exercise tasks, and participant characteristics to more clearly understand the effect of tDCS on muscle endurance of lower extremities.