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First Epileptic Seizure and Initial Diagnosis of Juvenile Myoclonus Epilepsy (JME) in a Transcranial Direct Current Stimulation (tDCS) Study– Ethical Analysis of a Clinical case
Neuroethics ( IF 2.6 ) Pub Date : 2020-07-01 , DOI: 10.1007/s12152-020-09444-6
Anna Sierawska , Vera Moliadze , Maike Splittgerber , Annette Rogge , Michael Siniatchkin , Alena Buyx

We discuss an epileptic incident in an undiagnosed 13-year old girl participating in a clinical study investigating the effects of transcranial direct current stimulation (tDCS) in healthy children and adolescents. This incident poses important research ethics questions with regard to study design, especially pertaining to screening and gaining informed consent. Potential benefits and problems of the incident also need to be considered. The ethical analysis of the case presented in this paper has been informed by an in-depth interview conducted after the incident with the child and the accompanying parent. We discuss the ethical implications of the epileptic incident, the need for improving screening procedures for studies with minors and for providing more effective communication. This case also underscores the problem of undetected teenage epilepsy in neuropsychological clinical studies and the necessity of raising more awareness of this issue. Since research in tDCS is an active and expanding field, we conclude with providing some recommendation that could ensure that future research on tDCS, or other therapies and neuro-interventions where there is a risk of triggering an epileptic seizure, take into account the specifics of teenage epilepsy and the need for more thorough provision of information during the process of gaining informed consent.



中文翻译:

经颅直流电刺激(tDCS)研究中的首次癫痫发作和少年肌阵挛性癫痫(JME)的初步诊断-临床病例的伦理分析

我们讨论了一名未经诊断的13岁女孩的癫痫事件,该女孩参加一项临床研究,研究经颅直流电刺激(tDCS)对健康儿童和青少年的影响。该事件对研究设计提出了重要的研究伦理问题,尤其是与筛选和获得知情同意有关。还需要考虑事件的潜在收益和问题。事件发生后,与孩子及其陪伴的父母进行了深入访谈,从而对本文中的案件进行了伦理分析。我们讨论了癫痫事件的伦理意义,对未成年人研究筛查程序的改进以及提供更有效沟通的必要性。该案例还强调了神经心理学临床研究中未发现的青少年癫痫的问题,以及增强对这一问题的认识的必要性。由于tDCS的研究是一个活跃且不断扩展的领域,因此我们最后提供一些建议,以确保将来对tDCS或可能引发癫痫发作的风险的其他疗法和神经干预的研究考虑到以下因素:青少年癫痫病以及在获得知情同意的过程中需要更彻底地提供信息。

更新日期:2020-07-01
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