Endovascular EEG device prospective multicenter single-arm clinical trial to confirm efficacy and safety performance on patients with Intractable Epilepsy: The EPSILON IE trial protocol

• Yuji Matsumaru,

  Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing

  Affiliations Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan, Epsilon Medical Inc., Tokyo, Japan

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• Ayataka Fujimoto ,

  Roles Conceptualization, Data curation, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing

  * E-mail: afujimotoscienceacademy@gmail.com

  Affiliations Epilepsy Center, Dokkyo Medical University School of Medicine, Tochigi, Japan, School of Rehabilitation Sciences, Seirei Christopher University, Shizuoka, Japan, Seirei Hamamatsu General Hospital, Hamamatsu, Shizuoka, Japan

  https://orcid.org/0000-0002-5308-2965

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• Yosuke Masuda,

  Roles Conceptualization, Investigation, Methodology, Project administration, Writing – review & editing

  Affiliation Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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• Hisayuki Hosoo,

  Roles Data curation, Investigation, Project administration, Writing – review & editing

  Affiliation Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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• Kota Araki,

  Roles Data curation, Investigation, Project administration, Writing – review & editing

  Affiliation Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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• Aiki Marushima,

  Roles Investigation, Project administration, Writing – review & editing

  Affiliation Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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• Kensuke Kawai,

  Roles Supervision, Writing – review & editing

  Affiliation Department of Neurosurgery, Jichi Medical University, Shimotsuke, Tochigi, Japan

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• Hiroki Ishida,

  Roles Project administration, Writing – review & editing

  Affiliation Epsilon Medical Inc., Tokyo, Japan

  https://orcid.org/0009-0000-8740-3993

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• Koichi Hashimoto,

  Roles Project administration, Writing – review & editing

  Affiliation Tsukuba Clinical Research and Development Organization (T-CReDo), University of Tsukuba, Tsukuba, Japan

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• Ryota Ishii,

  Roles Investigation, Methodology, Project administration, Writing – review & editing

  Affiliation Department of Biostatistics, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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• Bryan J. Mathis,

  Roles Writing – review & editing

  Affiliation Clinical Research Manuscript Elevation Service (CReME), University of Tsukuba, Tsukuba, Japan

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• Eiichi Ishikawa

  Roles Project administration, Supervision, Writing – review & editing

  Affiliation Department of Neurosurgery, Institute of Medicine, University of Tsukuba, Tsukuba, Japan

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