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

The Procedure: Known and Unknown Risks of Surgical Innovation

Although DBS for movement disorders in adults is an accepted treatment option, in children it still represents a surgical innovation, even for the most common indication, dystonia. As mentioned above, an innovation is defined as a procedure that significantly departs from standard or accepted practice and is characterized by evolving techniques, outcome measures, and patient selection.[11,31] The extent to which a surgical innovation deviates from standard practice is directly related to the extent to which it requires ethical oversight and regulation.[5]

Before proposing DBS for a pediatric patient, the health team should recognize that the risks, and often the benefits, of the procedure are not well understood. Available data are limited to small case series with specific institutional protocols that are poorly generalizable to other centers. Risks of the procedure may be higher in children when that procedure is performed using protocols derived from adult DBS. For example, early case series on pediatric DBS have reported higher rates of infection ranging from 5% to 33%, as compared to approximately 5% with adult DBS.[22,29,35] Since then, two series in which the pulse generator was implanted at a later date both reported an infection rate of 0%.[21,33] Furthermore, DBS leads and batteries are sized for use in adults, and the risks of skin erosion and hardware fracture seem to be higher in children.[25,29] An appreciation of the ways in which a standard procedure in adults (i.e., DBS) may be an innovative intervention in children is critical to determining the extent of ethical oversight required for its use in clinical and experimental indications.

Surgical innovations are also associated with evolving outcome measures.[31] Current instruments used to measure the success of DBS treatment may not be ideal, even for the most widely studied indication, dystonia. Originally created to assess primary torsion dystonia in adults, the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) has been adopted for pediatric use and is now the most commonly reported measure of dystonia impairment.[7] Intended for use in secondary dystonia, the Barry-Albright Dystonia Scale (BADS) is also frequently cited.[4] These scales often fail to capture a child's experience with illness (i.e., dystonia). For example, a recent study highlighting this showed that DBS improved individualized functional goals in the absence of significant changes in BFMDRS scores in children with secondary dystonia.[16]

Despite the uncertainties introduced by evolving techniques, patient selection, and outcome measures, clinicians have an obligation to apply DBS in appropriately selected candidates. Future studies will aim to clarify the extent to which pediatric DBS deviates from the adult equivalent, as well as the minimum level of evidence required before acceptance of the procedure.[19]