An Ethical Framework for Deep Brain Stimulation in Children

Benjamin Davidson, MD; Lior M. Elkaim; Nir Lipsman, MD, PhD; George M. Ibrahim, MD, PhD


Neurosurg Focus. 2018;45(3):e11 

In This Article

Ethical Framework for Pediatric DBS

Ethical frameworks function as scaffolding for public, institutional, and personal views toward an existing problem.[15] Ethical frameworks include common themes that transcend individual challenges, such as access, accountability, autonomy, client centeredness, collaboration, efficiency, equity, evidence, prevention, public involvement, quality, responsibility, sustainability, and protection of the vulnerable.[15] Given the ethical challenges unique to the conduct of DBS in children, we propose a bioethical framework centered around five primary expectations that may serve to advance dialogue regarding pediatric DBS (Table 2).

Expectation 1: Protection of the Child's Best Interest

Decisions and clinical hypotheses and their testing should be made in the spirit of the child's best interest. Since children are often unable to declare their treatment preferences because of immaturity or disability, treatments that support their development and decrease their suffering should be emphasized. An examination of a child's best interest may also encompass benefit to caregivers.[42] For example, reduced dystonia may facilitate the delivery of care and hygiene to the child by their caregivers, thus providing a net benefit. Although DBS research, for instance, in the form of clinical trials, is primarily designed to test an intervention that may benefit future patients, surgical trials are inherently accompanied by a reasonable expectation of benefit to the individual subject. Efforts to uphold the highest standards of ethical principles and mitigate therapeutic misconception during the conduct of clinical trials involving DBS in children are paramount.

Expectation 2: Decisions Made Within the Developmental Context

The use of DBS in children should be viewed through a developmental lens. The treating team should have a clear concept of the expected trajectory of the child's illness, their development, and how the proposed treatment fits within this larger picture. The timing of any proposed treatment should be clearly justified based on these factors, such as trying to prevent contractures from developing in the case of dystonia. For example, in refractory Tourette syndrome, the benefits of intervention should be weighed against an unknown and potentially favorable natural history. A holistic approach encompassing the child's medical, psychiatric, and social comorbidities and position should inform the presurgical discussions.

Expectation 3: Mitigating "Relative" Known and Unknown Risks to the Individual Child

Relatively little is known about the risks of DBS in pediatric patients and how they differ from those in adults, and all members of the treating team should be aware of this. In the conduct of pediatric DBS, the child's relative experience with illness must be weighed against uncertainty to minimize known and theoretical risks. The child's subjective experience should dictate the degree to which DBS can and should be pursued for an accepted or investigational indication.

The known benefits and harms of a child's current treatment, as well as their subjective experience of illness, should be balanced against the relatively unknown risks and benefits of DBS. For example, intrathecal baclofen therapy is an established, effective treatment for secondary generalized dystonia. The point at which DBS should be considered represents a balance of its unknown risks (and benefits) relative to the efficacy and tolerance of the established treatment (intrathecal baclofen). Presently, in most cases, the balance tips toward DBS when other treatments have become ineffective or harmful despite significant suffering due to the illness. As better data emerge, the decision to proceed with and the timing of the intervention is expected to be associated with less uncertainty and to pose fewer ethical dilemmas.

Expectation 4: Avoidance of Overreliance on the Adult Literature

The treating team and caregivers must be constantly cognizant that "children are not small adults." In addition to the unique risk and benefit profiles, the diseases manifested in children differ significantly from those in adults, as does a child's perception of illness. Incumbent on the treating physician is the need to approach pediatric DBS as uncharted territory and to take on the burden of demonstrating reasonable evidence for and against all elements of the treatment.

Expectation 5: Communicate and Collaborate With Other Practitioners

Each lesson learned in the pre-, intra-, and postoperative phase of DBS in the pediatric setting is extremely valuable and should be disseminated to the larger clinical community. Both positive and negative results require discussion and publication. For instance, given the heterogeneity of outcomes following secondary dystonia, it is incumbent upon the medical community to better define the ideal surgical candidates. A frank review of complications must also occur, with institutional oversight. Such practices have already improved outcomes following DBS in children.[21,33] Although small case series still provide valuable data, emphasis should be placed on collaborative registries, with standardized, prospective outcome reporting. Collaboration to harmonize protocols between institutions will be necessary to produce larger, more generalizable case series.