Elsevier

Brain Stimulation

Available online 13 February 2010
Brain Stimulation

Electrodes in the brain—Ethical criteria for research and treatment with deep brain stimulation for neuropsychiatric disorders

https://doi.org/10.1016/j.brs.2010.01.006Get rights and content

Background

Deep brain stimulation (DBS) has been used for neuropsychiatric disorders in clinical and research settings for almost 50 years now. Recent evidence demonstrates some efficacy in treating obsessive-compulsive disorder and major depression in patients refractory to other treatment modalities beyond single case reports. This has led to a considerable surge of clinical and commercial interest in DBS for psychiatric indications. Because of the high vulnerability of psychiatric patients, the lack of extensive short- and long-term data about effectiveness and adverse effects and the haunting history of psychosurgery, this new field in psychiatry raises important and specific ethical issues that have only rarely been systematically addressed so far.

Objective and Methods

We here review an evidence-based systematic ethical analysis of psychiatric DBS using the criteria of beneficence, nonmaleficence, and autonomy.

Conclusions

These criteria can easily be applied to research and future clinical application of DBS in neuropsychiatric disorders. This will prepare the ground for ethically justified, empirically comprehensive DBS in this highly vulnerable population and allow stringent future societal discussions about its legitimation.

Section snippets

Setting the stage

High-frequency electrical deep brain stimulation (DBS) of specific brain circuits has gained increasing acceptance in treatment of several neurologic disorders because of its high effectiveness and—compared with classical ablative neurosurgical interventions—its less invasive, largely reversible, and adjustable features.1 First evidence for efficacy has also been shown in studies of treatment-refractory psychiatric diseases, such as obsessive-compulsive disorder2, 3, 4, 5 and major depression6,

Ethical criteria for neuropsychiatric DBS—Stepping beyond common ethical references

Many current ethical perspectives draw on references to early psychosurgery17, 20 or the risk to alter a patient's personality15, 21 to delineate negative ethical criteria for psychiatric DBS. However, these references are of rather limited value for establishing positive ethical criteria that can be systematically applied in current research and clinical DBS to perform evidence-based ethical decision-making processes.22

At first sight, there is no need for specific ethical criteria for DBS in

Implementing procedural safeguards

Obviously, the specific challenges in assessing benefit, harm, and autonomy do not present a general argument to not perform DBS in psychiatric patients, yet they put emphasis on the need to carefully scrutinize DBS considerations, to study effects and adverse events with different outcome measures and methodologies and to openly report any kind of short- or long-term adverse events. In addition, like in other vulnerable populations (e.g., DBS in children with movement disorders or in Parkinson

Level of evidence for DBS efficacy and safety

So far, most available data about psychiatric DBS has been uncontrolled, thus raising the question what level of evidence should be used to establish safety and efficacy. This complex question cannot be addressed here in full detail, but from an ethical perspective it seems obvious to ask for randomized controlled trials as only they can establish true efficacy and rule out possible confounding factors, previously described. It was well shown for DBS in Parkinson's disease,34 primary dystonia,35

Conclusion

DBS might turn out to be a focused and efficacious treatment option for well-selected psychiatric patients resistant to traditional methods, and maybe also in the future for those patients who show a significant, yet still insufficient effect to other treatments. There are no inherent ethical objections; the same ethical criteria that are already widely used to assess other biomedical interventions can be productively applied for analyzing DBS studies and for clinical decision making. These

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  • Cited by (0)

    Dr. Schlaepfer received limited support for an Investigator Initiated Study on DBS in resistant major depression from Medtronic Inc., a manufacturer of DBS equipment between 2004 and 2007.

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