Clinician Perspectives on Levels of Evidence and Oversight for Deep Brain Stimulation for Treatment-Resistant Childhood OCD.

Approximately 10-20% of children with obsessive-compulsive disorder (OCD) have treatment-resistant presentations, and there is likely interest in developing interventions for this patient group, which may include deep brain stimulation (DBS). The World Society for Stereotactic and Functional Neurosurgery has argued that at least two successful randomized controlled trials should be available before DBS treatment for a psychiatric disorder is considered "established." The FDA approved DBS for adults with treatment-resistant OCD under a humanitarian device exemption (HDE) in 2009, which requires that a device be used to manage or treat a condition impacting 8,000 or fewer patients annually in the United States. DBS is currently offered to children ages 7 and older with treatment-resistant dystonia under an HDE. Ethical and empirical work are needed to evaluate whether and under what conditions it might be appropriate to offer DBS for treatment-resistant childhood OCD. To address this gap, we report qualitative data from semi-structured interviews with 25 clinicians with expertise in this area. First, we report clinician perspectives on acceptable levels of evidence to offer DBS in this patient population. Second, we describe their perspectives on institutional policies or protocols that might be needed to effectively provide care for this patient population.

Participant perceptions of changes in psychosocial domains following participation in an adaptive deep brain stimulation trial.

BACKGROUND: There has been substantial controversy in the neuroethics literature regarding the extent to which deep brain stimulation (DBS) impacts dimensions of personality, mood, and behavior. OBJECTIVE/HYPOTHESIS: Despite extensive debate in the theoretical literature, there remains a paucity of empirical data available to support or refute claims related to the psychosocial changes following DBS. METHODS: A mixed-methods approach was used to examine the perspectives of patients who underwent DBS regarding changes to their personality, authenticity, autonomy, risk-taking, and overall quality of life. RESULTS: Patients (n = 21) who were enrolled in adaptive DBS trials for Parkinson's disease, essential tremor, obsessive-compulsive disorder, Tourette's syndrome, or dystonia participated. Qualitative data revealed that participants, in general, reported positive experiences with alterations in what was described as 'personality, mood, and behavior changes.' The majority of participants reported increases in quality of life. No participants reported 'regretting the decision to undergo DBS.' CONCLUSION(S): The findings from this patient sample do not support the narrative that DBS results in substantial adverse changes to dimensions of personality, mood, and behavior. Changes reported as "negative" or "undesired" were few in number, and transient in nature.

Engagement, Exploitation, and Human Intracranial Electrophysiology Research.

Motivated by exploitation concerns, we argue for the importance of participant engagement in basic human intracranial electrophysiology research. This research takes advantage of unique neurosurgical opportunities to better understand complex systems of the human brain, but it also exposes participants to additional risks without immediate therapeutic intent. We argue that understanding participant values and incorporating their perspectives into the research process may (i) help determine whether and to what extent research practices and the resulting distributions of risks and benefits constitute exploitation and (ii) contribute to building a brain research paradigm that is genuinely responsive to participant values. More broadly, we highlight the importance of paying attention to participant interests in non-therapeutic brain research.

Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost.

BACKGROUND: Clinical trial participants who benefit from experimental neural devices for the treatment of debilitating and otherwise treatment-resistant conditions are generally not ensured continued access to effective therapy or maintenance of devices at the conclusion of trials. OBJECTIVE/HYPOTHESIS: Post-trial obligations have been extensively examined in the context of drug trials, but there has been little empirical examination of stakeholder perspectives regarding these obligations in the rapidly growing field of neural device research. METHODS: This study examined the perspectives of 44 stakeholders (i.e., 23 researchers and 21 patient-participants) involved in implantable neural device trials. RESULTS: Researchers were concerned about current post-trial management, identified barriers like cost, and suggested ways to improve the system. Many patient-participants were unaware of whether they would have post-trial access, but most thought they should keep devices if beneficial, and agreed with researchers that more should be done to help them keep and maintain these neural devices. CONCLUSION: To our knowledge, this is the first in-depth examination of researcher perspectives regarding continued access to experimental neural devices and only the second such examination of patient-participant perspectives. These data can help inform future ethical and policy decisions about post-trial access to implantable neurotechnology.

Risk of childhood obesity in the toddler offspring of mothers with gestational diabetes.

OBJECTIVE: To estimate whether children aged 2-4 years of mothers with gestational diabetes are at increased risk for childhood obesity. Secondary objectives included examining the associations between maternal body mass index (BMI), gestational weight gain, large-for-gestational-age (LGA) newborns, and race or ethnicity with childhood obesity. METHODS: Retrospective cohort study of women with and without gestational diabetes mellitus (GDM), and their term offspring, who delivered at a single institution between 2004 and 2007. RESULTS: We identified 255 woman and toddler pairs with GDM and 1,838 woman and toddler pairs without GDM. Mean BMI percentiles of toddlers of women with and without GDM did not differ (mean 51.8 percentile compared with 55.3 percentile; P=.12). Adjusted logistic regression models demonstrated increased risk of toddler obesity with higher prepregnancy BMI compared with normal-weight mothers (adjusted odds ratio [OR] 2.56, 95% confidence interval [CI] 1.92-3.42). Additionally, LGA increased the odds of toddler overweight and obesity (adjusted OR 1.8, 95% CI 1.4-2.3). CONCLUSION: Childhood obesity was not associated with GDM but was associated with higher prepregnancy maternal BMI and LGA. LEVEL OF EVIDENCE: II.