Editorial. An ethical framework for deep brain stimulation in children

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

doi:10.3171/2018.7.focus18219

Cited by 19 publications

(14 citation statements)

References 43 publications

(66 reference statements)

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“…Although increasingly offered to children for expanding indications, it is often considered an experimental therapy in this context. A proposed ethical framework to guide the conduct of DBS in children has been proposed, to which this study adheres [ 64 ]. The principles of this framework include viewing outcomes in a developmentally relevant context, cautiously applying adult data, and weighing the timing of the procedure [ 64 ].…”

Section: Discussionmentioning

confidence: 99%

An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol

Yan

Siegel

Breitbart

et al. 2022

Pilot Feasibility Stud

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Background Children and youth with autism spectrum disorder (ASD) may manifest self-injurious behaviors (SIB) that may become severe and refractory with limited pharmacologic or behavioral treatment options. Here, we present the protocol of a prospective, mixed-methods study to assess the safety and efficacy of deep brain stimulation (DBS) of the nucleus accumbens (NAcc) for children and youth with ASD and severe, refractory SIB. Methods This is a prospective, single-center, single-cohort, open-label, non-randomized pilot trial of 6 patients. Participants will be recruited through specialized behavioral clinics with persistent severe and refractory SIB following standard and intensive interventions. Following NAcc-DBS, participants will be enrolled in the study for 12 months. The primary objectives of the study are safety and feasibility, assessed by rate of recruitment and identification of factors impacting adherence to follow-up and study protocol. Potential treatment efficacy will be assessed by changes in the Children’s Yale-Brown Obsessive-Compulsive Scale in ASD (CYBOCS-ASD), the Behavior Problems Index (BPI), the Inventory of Statements about Self-Injury (ISAS) and the Repetitive Behavior Scale-Revised (RBS-R) questionnaires. Additional clinical outcomes will be assessed, including measures of participant and caregiver quality of life, actigraph measurements, and positron emission tomography (PET) changes following DBS. Discussion This study will be the first to evaluate the effect of DBS of the NAcc on a pediatric population in a controlled, prospective trial. Secondary outcomes will improve the understanding of behavioral, neuro-imaging, and electrophysiologic changes in children with ASD and SIB treated with DBS. This trial will provide an estimated effect size of NAcc-DBS for severe refractory SIB in children with ASD in preparation for future comparative trials. Trial registration Registration on ClinicalTrials.gov was completed on 12 June 2019 with the Identifier: NCT03982888.

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Section: Discussionmentioning

confidence: 99%

An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol

Yan

Siegel

Breitbart

et al. 2022

Pilot Feasibility Stud

Self Cite

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“…4 17 This challenges clinicians when performing risk-potential benefit analyses for their patients. 4 In order to provide upmost transparency, we specify parameters for each statistic mentioned below.…”

Section: Non-maleficencementioning

confidence: 99%

“…19 It is unclear whether any statistics gained from predominantly adult patient populations can be extrapolated to paediatric patient populations. 4 Cognitive decline has neither reliably nor consistently been associated with DBS in patients with TS. 20 Long-term prospective data on paediatric patients who have received DBS for TS are lacking.…”

Section: Non-maleficencementioning

confidence: 99%

“…brains. 4 It is for this reason that DBS should be considered only for paediatric patients with severe, intractable TS. And yet, the relatively reversible nature of DBS is important.…”

Section: Clinical Ethicsmentioning

confidence: 99%

“…DBS for paediatric patients is considered a surgical innovation. 4 Current DBS guidelines for patients with TS were created by international experts, published in 2006 and updated in 2015. 3 Indications include: (1) confirmed TS diagnosis; (2) proof that tics are the major source of impairment; and (3) condition is refractory to multiple pharmacological regimens.…”

Section: Introductionmentioning

confidence: 99%

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Paediatric deep brain stimulation: ethical considerations in malignant Tourette syndrome

et al. 2020

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Gilles de la Tourette syndrome (TS) is a childhood neuropsychiatric disorder characterised by the presence of motor and vocal tics. Patients with malignant TS experience severe disease sequelae; risking morbidity and mortality due to tics, self-harm, psychiatric comorbidities and suicide. By definition, those cases termed ‘malignant’ are refractory to all conventional psychiatric and pharmacological regimens. In these instances, deep brain stimulation (DBS) may be efficacious. Current 2015 guidelines recommend a 6-month period absent of suicidal ideation before DBS is offered to patients with TS. We therefore wondered whether it may be ethically justifiable to offer DBS to a minor with malignant TS. We begin with a discussion of non-maleficence and beneficence. New evidence suggests that suicide risk in young patients with TS has been underestimated. In turn, DBS may represent an invaluable opportunity for children with malignant TS to secure future safety, independence and fulfilment. Postponing treatment is associated with additional risks. Ultimately, we assert this unique risk-benefit calculus justifies offering DBS to paediatric patients with malignant TS. A multidisciplinary team of clinicians must determine whether DBS is in the best interest of their individual patients. We conclude with a suggestion for future TS-DBS guidelines regarding suicidal ideation. The importance of informed consent and assent is underscored.

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Ethical and Legal Issues in Deep Brain Stimulation: An Overview

Desmoulin-Canselier

2020

Neuroscience and Law

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Editorial. An ethical framework for deep brain stimulation in children

Cited by 19 publications

References 43 publications

An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol

An open-label prospective pilot trial of nucleus accumbens deep brain stimulation for children with autism spectrum disorder and severe, refractory self-injurious behavior: study protocol

Paediatric deep brain stimulation: ethical considerations in malignant Tourette syndrome

Ethical and Legal Issues in Deep Brain Stimulation: An Overview

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