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Neurostimulation Devices for Cognitive Enhancement: Toward a Comprehensive Regulatory Framework

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Abstract

There is mounting evidence that non-invasive brain stimulation devices - transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS) could be used for cognitive enhancement. However, the regulatory environment surrounding such uses of stimulation devices is less clear than for stimulant drugs—a fact that has already been commercially exploited by several companies. In this paper, the mechanism of action, uses and adverse effects of non-invasive neurostimulation devices are reviewed, along with social and ethical challenges pertaining to their use as cognitive enhancements. Two regulatory approaches that could be used to facilitate responsible use of these devices as products and services are outlined. Apart from establishing the urgently needed comprehensive regulatory framework, they might provide a starting point for establishing long term physiological and social effects of enhancement uses of tDCS and TMS.

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Notes

  1. A notable example is: “Schoolchildren who struggle to grasp mathematics could benefit from having their brains roused with electricity” [27].

  2. The inhibitory effect of cathodal stimulation seems to be consistent in motor studies; in the cognitive category, memory and executive function are affected, whereas the evidence on effects on language ability is not conclusive (see [34]).

  3. The question of liability for harmful effects after the training has been provided is salient, but easily answered in this context. Just as driving instructors are not liable for the traffic accidents made by their trainees after they pass the exams and receive their licenses, so tDCS trainers should not be held responsible for adverse effects caused by “trained and certified” individuals. I am grateful to an anonymous reviewer for constructive comments that have prompted me to make this more clear.

  4. Luber & Lisanby [5] have reviewed evidence on three different kinds of enhancement effects, along with current hypotheses for explaining the phenomena: (i) enhancement via nonspecific effects of TMS; (ii) enhancement via “addition by subtraction”, and (iii) enhancement effects via direct TMS to specific task-related brain regions.

  5. Compared to tDCS, TMS is much more dangerous. The danger of causing seizures is present even in controlled laboratory settings, let alone in “at home” uses, which basically justifies a more restrictive approach. I am grateful to an anonymous reviewer for constructive comments that have prompted me to make this more clear.

  6. The reliance on professional guidelines is problematic in two separate respects: 1. Such guidelines do not exert sufficient regulatory control, and 2. The lack of state involvement exacerbates the problem of lack of control. I am grateful to an anonymous reviewer for the constructive comments that provided input for this clarification.

  7. This assertion might need to be qualified. Namely, not everyone will see the trade-offs between enhancement effects and potential side-effects of tDCS and TMS in the same light. As I argue elsewhere (see [40]), the lack of adequate information on long term effects and even short term benefits (the issue how laboratory findings of improvement in cognition relate to everyday performance is far from clear) complicates the comparison of evaluations of benefits, harms and positional (dis)advantages. Since they are at this point not quantifiable for, say, rational choice modeling, the assumption regarding offsetting the concerns of fairness could be provisionally accepted, until disputed by further evidence. I am grateful to an anonymous reviewer for constructive comments that have prompted me to make this more clear.

  8. This could raise an issue of fairness for people who would like to benefit from enhancement services, but are unwilling or unable to demonstrate sufficient understanding of such complicated issues such as brain regions, electrical and magnetic fields, etc. Now, whether such an issue would materialize or not is an open question, but the provision that EDM would need to be fine-tuned (perhaps by dividing the exam in the theoretical and practical part, with one being sufficient to benefit from the service and both being necessary for product purchase) could offset this concern. I am grateful to an anonymous reviewer for constructive comments that have prompted me to make this more clear.

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Authors and Affiliations

  1. University of Tübingen, 72074, Tübingen, Germany

    Veljko Dubljević

  2. Neuroethics Research Unit, Institut de recherches cliniques de Montréal (IRCM), 110 avenue des Pins Ouest, Montréal, QC, H2W lR7, Canada

    Veljko Dubljević

  3. Department of Neurology and Neurosurgery, McGill University, Montréal, Canada

    Veljko Dubljević

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Dubljević, V. Neurostimulation Devices for Cognitive Enhancement: Toward a Comprehensive Regulatory Framework. Neuroethics 8, 115–126 (2015). https://doi.org/10.1007/s12152-014-9225-0

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