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 Parkinson's 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.

Sectio parva for fetal preservation.

Selective abdominal delivery, or sectio parva, is cesarean delivery of one of multiple fetuses, but not the other(s). Eleven cases have been reported for the purpose of aborting one twin, and this is the second report of an attempt to improve the outcome of both twins. Perinatal outcomes have ranged from almost immediate delivery of the second twin because of placental abruption, to elective delivery of the survivor at term.

An account of the usefulness of a pilot clinical ethics program at a community hospital.

This article describes the development and implementation of a six-month pilot clinical ethics program at Saint Thomas Hospital (Nashville, Tenn). To assess the impact of this program, baseline data were gathered from a self-selected sample of critical and special care unit nurses and physicians about the "most troublesome" ethical dilemmas in their practices. Nurses and physicians reported facing similar dilemmas in practice. Nurses believed that chaplains and peers were most "beneficial" in resolving their "most troublesome" cases; physicians did not deem one particular individual or service to be of any greater benefit than any other in dilemma resolution. Nurses and physicians indicated that in many cases patients and families did not appear involved in the process. In a posttest survey following the pilot program, nurses rated the beneficial role of chaplains somewhat lower and agreed that the clinical ethics service was beneficial. As with the pretest sample, the posttest nurses evaluated the role of the attending physician as "detrimental" to resolving their ethical conflicts. In the posttest, physicians ranked the role of the clinical ethicist as comparable to that of chaplains and social workers.