よむ、つかう、まなぶ。
資料１－２ 早期導入を要望する医療機器等に関する要望書【No.2024-1】 (16 ページ)
出典
| 公開元URL | https://www.mhlw.go.jp/stf/newpage_42226.html |
| 出典情報 | 医療ニーズの高い医療機器等の早期導入に関する検討会（第38回 8／9）《厚生労働省》 |
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（別添様式１）
•
Heck C.N.et al., Two-year seizure reduction in adults with medically intractable partial onset
epilepsy treated with responsive neurostimulation: Final results of the RNS system pivotal trial,
Epilepsia, 55(3):432–441, 2014 36
•
Bergey G.K.et al., Long-term treatment with responsive brain stimulation in adults with
refractory partial seizures. Neurology 84(8): 810-817, 2015 28
•
Nair D.R.et al., Nine-year prospective efficacy and safety of brain responsive neurostimulation for
focal epilepsy, Neurology, 2020;95:e1244-e1256 12
•
Geller E.B.et al., Brain-responsive neurostimulation in patients with medically intractable mesial
temporal lobe epilepsy. Epilepsia 58(6): 994-1004, 2017 29
•
Jobst B.J.et al., Brain-responsive neurostimulation in patients with medically intractable
seizures arising from eloquent and other neocortical areas, Epilepsia, 58(6):1005–1014, 2017 24
•
Sun F.T. et al., The RNS System: responsive cortical stimulation for the treatment of refractory
partial epilepsy. Expert Rev. Med. Devices 11(6): 563-572, 2014 30
•
Loring D.W.et al., Differential neuropsychological outcomes following targeted responsive
neurostimulation for partial-onset epilepsy. Epilepsia 56(11): 1836-1844, 201531
•
Quigg M et al., Interrater reliability in interpretation of electrocorticographic seizure detections of
the responsive neurostimulator. Epilepsia 56(6): 968-971, 2015 32
•
King-Stephens D.et al., Lateralization of mesial temporal lobe epilepsy with chronic ambulatory
electrocorticography. Epilepsia 56(6): 959-967, 2015 33
•
Meador K.J.et al., Quality of life and mood in patients with medically intractable epilepsy treated
with targeted responsive neurostimulation, Epilepsy Behav. 2015 Apr:45:242-7. 4
•
Razavi B.et al., Real-world experience with direct brain-responsive neurostimulation for focal
onset seizures, Epilepsia. 2020;61:1749–1757 9
•
Singh R.K.et al., Responsive neurostimulation in drug resistant pediatric epilepsy: findings from
the epilepsy surgery subgroup of the pediatric epilepsy research consortium, Pediatr Neurol. 2023
Jun:143:106-112. 2
•
Kerezoudis P.et al., Safety and efficacy of responsive neurostimulation in the pediatric population:
Evidence from institutional review and patient-level meta-analysis, Epilepsy Behav. 2022 Apr:129:10864 3
•
Nagahama Y.et al., Real-World Preliminary Experience With Responsive Neurostimulation in
Pediatric Epilepsy: A Multicenter Retrospective Observational Study Neurosurgery 89:997–1004,
20211
•
M Sprengers M.et al., Deep brain and cortical stimulation for epilepsy, The Cochrane
database of systematic reviews 2017, Issue 7. Art. No.: CD008497..17
海外における臨床試験等
（参照文献 29）
書誌事項
Geller E.B. et al.: Epilepsia 58(6): 994-1004, 2017 29
試験・研究デザイン
RNS システムの前向き研究による治験内で治療された内側側頭葉てんか
ん(MTLE)患者が選定された。RNS 埋め込み後の発作減少率は 2～6 年にわ
たり、術前ベースライン期間の発作頻度と比較してデータを算出。安全性
16
•
Heck C.N.et al., Two-year seizure reduction in adults with medically intractable partial onset
epilepsy treated with responsive neurostimulation: Final results of the RNS system pivotal trial,
Epilepsia, 55(3):432–441, 2014 36
•
Bergey G.K.et al., Long-term treatment with responsive brain stimulation in adults with
refractory partial seizures. Neurology 84(8): 810-817, 2015 28
•
Nair D.R.et al., Nine-year prospective efficacy and safety of brain responsive neurostimulation for
focal epilepsy, Neurology, 2020;95:e1244-e1256 12
•
Geller E.B.et al., Brain-responsive neurostimulation in patients with medically intractable mesial
temporal lobe epilepsy. Epilepsia 58(6): 994-1004, 2017 29
•
Jobst B.J.et al., Brain-responsive neurostimulation in patients with medically intractable
seizures arising from eloquent and other neocortical areas, Epilepsia, 58(6):1005–1014, 2017 24
•
Sun F.T. et al., The RNS System: responsive cortical stimulation for the treatment of refractory
partial epilepsy. Expert Rev. Med. Devices 11(6): 563-572, 2014 30
•
Loring D.W.et al., Differential neuropsychological outcomes following targeted responsive
neurostimulation for partial-onset epilepsy. Epilepsia 56(11): 1836-1844, 201531
•
Quigg M et al., Interrater reliability in interpretation of electrocorticographic seizure detections of
the responsive neurostimulator. Epilepsia 56(6): 968-971, 2015 32
•
King-Stephens D.et al., Lateralization of mesial temporal lobe epilepsy with chronic ambulatory
electrocorticography. Epilepsia 56(6): 959-967, 2015 33
•
Meador K.J.et al., Quality of life and mood in patients with medically intractable epilepsy treated
with targeted responsive neurostimulation, Epilepsy Behav. 2015 Apr:45:242-7. 4
•
Razavi B.et al., Real-world experience with direct brain-responsive neurostimulation for focal
onset seizures, Epilepsia. 2020;61:1749–1757 9
•
Singh R.K.et al., Responsive neurostimulation in drug resistant pediatric epilepsy: findings from
the epilepsy surgery subgroup of the pediatric epilepsy research consortium, Pediatr Neurol. 2023
Jun:143:106-112. 2
•
Kerezoudis P.et al., Safety and efficacy of responsive neurostimulation in the pediatric population:
Evidence from institutional review and patient-level meta-analysis, Epilepsy Behav. 2022 Apr:129:10864 3
•
Nagahama Y.et al., Real-World Preliminary Experience With Responsive Neurostimulation in
Pediatric Epilepsy: A Multicenter Retrospective Observational Study Neurosurgery 89:997–1004,
20211
•
M Sprengers M.et al., Deep brain and cortical stimulation for epilepsy, The Cochrane
database of systematic reviews 2017, Issue 7. Art. No.: CD008497..17
海外における臨床試験等
（参照文献 29）
書誌事項
Geller E.B. et al.: Epilepsia 58(6): 994-1004, 2017 29
試験・研究デザイン
RNS システムの前向き研究による治験内で治療された内側側頭葉てんか
ん(MTLE)患者が選定された。RNS 埋め込み後の発作減少率は 2～6 年にわ
たり、術前ベースライン期間の発作頻度と比較してデータを算出。安全性
16