脳深部刺激法(DBS)をめぐるドイツとフランスの事情 The clinical trials of deep brain stimulation in Germany and France

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ヒトの脳内神経回路網の一部を植込み電極と体内埋設型刺激デバイスで刺激する脳深部刺激療法(DBS)により、不随意運動など多くの脳機能障害が劇的に改善されることから、日本でもこの治療を受ける患者が年々増加している。近年、うつ病や強迫性障害などの精神疾患に対してもDBSの効果が報告され、ドイツ、フランス、ベルギー、USA、カナダ等で治療として医学的な実験(治験)が開始されている。しかしながらDBSは脳内の神経回路網に組み込まれた刺激デバイスが脳機能を改変する危険性を孕んでおり、特に精神疾患ではその影響が大きいと考えられる。欧米では、治験をどのような安全基準で行なっているのか。ここでは、2008年1月にドイツ、フランスで行なった調査を踏まえ、精神疾患に対するDBS治療の安全性や適用範囲、患者の選択基準、人格に与える影響や社会的な懸念、さらには過去に精神疾患治療に使われたロボトミー手術などから倫理面を考察した。

Deep Brain Stimulation (DBS) is a surgical medical treatment involving the implantation of a medical artificial device which sends electrical impulses to specific parts of the brain. DBS in the selected brain areas has provided remarkable therapeutic benefits for treatment-resistant diseases, such as Parkinson's disease. DBS can directly change brain activities in a controlled manner, and its effects are reversible. Lately, the clinical trials of DBS have been applied to various psychiatric disorders in EU, USA and Canada, such as obsessive compulsive disorder, Tourette syndrome and severe depression. Nevertheless, DBS therapies for affective disorders are still at the experimental stage and they may contain risks in implanting the device into a person's brain which possibly alters that person's brain function and hence his personal identity. Based on the experiences of Germany and France, this paper will examine the safety of DBS treatment for psychiatric disorders, the patient selection criteria, and etc.. The conditions for proper application of the DBS technique will also be clarified hereby. It will be argued in this paper that for psychiatric diseases, the DBS specialists can never decide alone and psychiatrists always need to be consulted to avoid possible failures resulting from mistakes in applying this technique. In real practice, the medical doctors usually consider that very sick adult patients are competent to give informed consent. Although the formal signature of consent from a family member is not a compulsory requirement family support for patients is considered crucially important. In France, the consent of the patient is the principal requirement for adopting DBS treatment; yet, the situation becomes difficult when the patient is considered unable to make an informed and rational decision. Under such circumstances, the decision could be then made by a legal representative. Previous medical practices of lobotomy have revealed many problems and concerns which need to be resolved. Although lobotomy has certain benefits, it has been over applied to massive cases without any well-defined criteria and its practice was also poorly designed. Therefore, the new techniques of DBS must be considerably better defined in terms of its criteria, procedure and ethical boundaries to avoid possible bioethical mistakes.

収録刊行物

  • 生命倫理

    生命倫理 19(1), 44-51, 2009

    日本生命倫理学会

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各種コード

  • NII論文ID(NAID)
    110007659915
  • NII書誌ID(NCID)
    AN10355291
  • 本文言語コード
    JPN
  • 資料種別
    ART
  • ISSN
    13434063
  • データ提供元
    CJP書誌  CJP引用  NII-ELS  J-STAGE 
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