Mark J. Bliton

Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease.

BACKGROUND Deep brain stimulation (DBS) is an effective and approved therapy for advanced Parkinsons disease (PD), and a recent study suggests efficacy in mid-stage disease. This manuscript reports the results of a pilot trial investigating preliminary safety and tolerability of DBS in early PD. METHODS Thirty subjects with idiopathic PD (Hoehn & Yahr Stage II off medication), age 50-75, on medication ≥6 months but ≤4 years, and without motor fluctuations or dyskinesias were randomized to optimal drug therapy (ODT) (n = 15) or DBS + ODT (n = 15). Co-primary endpoints were the time to reach a 4-point worsening from baseline in the UPDRS-III off therapy and the change in levodopa equivalent daily dose from baseline to 24 months. RESULTS As hypothesized, the mean UPDRS total and part III scores were not significantly different on or off therapy at 24 months. Medication requirements in the DBS + ODT group were lower at all time points with a maximal difference at 18 months. With a few exceptions, differences in neuropsychological functioning were not significant. Two subjects in the DBS + ODT group suffered serious adverse events; remaining adverse events were mild or transient. CONCLUSIONS This study demonstrates that subjects with early stage PD will enroll in and complete trials testing invasive therapies and provides preliminary evidence that DBS is well tolerated in early PD. The results of this trial provide the data necessary to design a large, phase III, double-blind, multicenter trial investigating the safety and efficacy of DBS in early PD.

Deep brain stimulation in early Parkinson's disease: Enrollment experience from a pilot trial

BACKGROUND Deep brain stimulation (DBS) of the subthalamic nucleus is an accepted therapy for advanced Parkinsons disease (PD). In animal models, pharmacologic ablation and stimulation of the subthalamic nucleus have resulted in clinical improvement and, in some cases, improved survival of dopaminergic neurons. DBS has not been studied in the early stages of PD, but early application should be explored to evaluate safety, efficacy, and the potential to alter disease progression. METHODS We are conducting a prospective, randomized, single-blind clinical trial of optimal drug therapy (ODT) compared to medication plus DBS (ODT + DBS) in subjects with Hoehn & Yahr Stage II idiopathic PD who are without motor fluctuations or dementia. We report here subject screening, enrollment, baseline characteristics, and adverse events. RESULTS 30 subjects (average age 60 ± 6.9 years, average duration of medicine 2.1 ± 1.3 years, average UPDRS-III scores 14.9 on medication and 27.0 off medication) are enrolled in the ongoing study. Twelve of 15 subjects randomized to DBS experienced perioperative adverse events, the majority of which were related to the procedure or device and resolved without sequelae. Frequently reported adverse events included wound healing problems, headache, edema, and confusion. CONCLUSION This report demonstrates that subjects with early stage PD can be successfully recruited, consented and retained in a long-term clinical trial of DBS. Our ongoing pilot investigation will provide important preliminary safety and tolerability data concerning the application of DBS in early stage PD.

Strange, But Not Stranger: The Peculiar Visage of Philosophy in Clinical Ethics Consultation

Baylis, Tomlinson, and Hoffmaster each raise a number of critiques in response to Blitons manuscript. In response, we focus on three themes we believe run through each of their critiques. The first is the ambiguity between the role of ethics consultation within an institution and the role of the actual ethics consultant in a particular situation, as well as the resulting confusion when these roles are conflated. We explore this theme by revisiting the question of “Whats going on?” in clinical ethics consultations. Moving from those issues associated with the role of the ethics consultant to those associated with the role of inquiry within the practice of ethics consultation, we then take up the serious challenge that Bliton seems shackled by the assumptions and institutional dispositions embedded in the medical culture in which he is working. This reveals the second theme, namely that there is a risk of co-optation when acting in a role that derives its legitimacy from institutional sources. Finally, we focus on an even more problematic implication stemming from the first two, namely that the focus on institutional power as the crucial factor for determining ethical significance has the effect of distorting, and perhaps obscuring, other forms of relational, interpersonal, and moral meaning.

Traversing boundaries: Clinical ethics, moral experience, and the withdrawal of life supports

While many have suggested that to withdraw medical interventions is ethically equivalent to withholding them, the moral complexity of actually withdrawing life supportive interventions from a patient cannot be ignored. Utilizing interplay between expository and narrative styles, and drawing upon our experiences with patients, families, nurses, and physicians when life supports have been withdrawn, we explore the changeable character of “boundaries” in end-of-life situations. We consider ways in which boundaries imply differences – for example, between cognition and performance – and how the encounter with boundaries can generate altered meanings important for understanding decisions and actions in these contexts. We conclude that the reliance on mere roles to support the moral weight of withdrawing medical interventions is inadequate. Roles that lead us to such moments are exceeded by the responsibility encountered in such moments. And here, we suggest, is the momentous character of withdrawal: it presents the grave astonishment, the trembling awe, in the “not-being-there” of the other in death.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

BACKGROUND Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinsons disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinsons disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. OBJECTIVE We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinsons disease and discuss previous failed attempts at neuroprotection. METHODS We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinsons disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. RESULTS Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinsons disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. CONCLUSIONS This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinsons disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinsons disease.

Ethics Talk; Talking Ethics: An Example of Clinical Ethics Consultation

This written account of a clinical encounter - depicting fragments of a more extensive array of events - attempts to exemplify many facets and associated complexities of clinical ethics consultation. Within the general telling, I provide more detailed portrayals of several key events. In secion 1, I document briefly my initial interactions at the beginning of the consultation, focusing on the information gained - in the context of those interactions - as I read the medical chart of Mrs. Rose. Next in section 2, I briefly describes my initial conversation with Mrs. Roses three sons. Section 3 illustrates several questions raised in sections 1 and 2. Then section 4 presents my encounter with Paul, the youngest son, as he was carrying out his vigil at his mothers bedside in the hospital. Section 5 chronicles my interactions with several care providers involved in Mrs. Roses situation, including two different meetings that occurred with Mrs. Roses attending physician. I conclude in section 6 by telling about a conversation I had with Mrs. Roses middle son, Russell, approximately one month after Mrs. Rose died.

Responsibility after the apparent end: 'following-up' in clinical ethics consultation.

Clinical ethics literature typically presents ethics consultations as having clear beginnings and clear ends. Experience in actual clinical ethics practice, however, reflects a different characterization, particularly when the moral experiences of ethics consultants are included in the discussion. In response, this article emphasizes listening and learning about moral experience as core activities associated with clinical ethics consultation. This focus reveals that responsibility in actual clinical ethics practice is generated within the moral scope of an ethics consultants activities as she or he encounters the unique and specific features that emerge from interactions with a specific patient, or family, or practitioner within a given situation and over time. A long-form narrative about an ethics consultants interactions is interwoven with a more didactic discussion to highlight the theme of responsibility and to probe questions that arise regarding follow-up within the practice of clinical ethics consultation.

Echo Calling Narcissus: What Exceeds the Gaze of Clinical Ethics Consultation?

Guiding our response in this essay is our view that current efforts to demarcate the role of the clinical ethicist risk reducing its complex network of authorizations to sites of power and payment. In turn, the role becomes susceptible to various ideologies—individualisms, proceduralisms, secularisms—that further divide the body from the web of significances that matter to that body, where only she, the patient, is located. The security of policy, standards, and employment will pull against and eventually sever the authorization secured by authentic moral inquiry. Instead of asking “What do I need to know?”, the question animating the drive to standardize will be “What is the policy or standard?” The claims of the authors in this issue of HEC Forum confirm these suspicions.

Exploring Layers of Meaning with Deep Brain Stimulation Patients

preferences if they change?). The solution of Müller and Christen is to propose a contingent advance directive policy and, more broadly, to bracket these concerns over autonomy by stating that “the ethically decisive question is not whether DBS can alter the personality or not, but whether it does so in a good or bad way.” By default, the answer may come to depend on clinical indication: In DBS for PD with predominantly motor symptoms, clinicians will tend to implicitly privilege the patient’s preoperative personality as more authentic and rational than the postoperative, which is suspicious for a pathological component; in DBS for depression, the reverse will hold true. The dissemination of any more nuanced view will require a public discourse between neurosurgeons and ethicists. As scientific advances in DBS enable treating more patients for more neuropsychiatric conditions, there will be a concomitant impetus for our community to drive the development of neuroethical guidelines and the thoughtful application of philosophy to the everyday concerns of patient autonomy and informed consent.

Deep Brain Stimulation for Early-Stage Parkinson's Disease: An Illustrative Case

Objectives:  Subthalamic nucleus (STN) deep brain stimulation (DBS) is an effective intervention in advanced Parkinsons disease (PD), but its efficacy and safety in early PD are unknown. We are conducting a randomized pilot trial investigating DBS in early PD. This report describes one participant who received bilateral STN‐DBS.