Charles 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.

Intrathecal baclofen pump implantation during pregnancy

Spasticity is a common, potentially disabling complication of spinal cord injury (SCI) that may be exacerbated by pregnancy. Twelve percent of women who become pregnant following SCI report a worsening of their spasticity during pregnancy and 15% have “significantly increased spasticity” during labor.1 Yet there is minimal research available concerning spasticity management during pregnancy. Intrathecal baclofen (ITB) is Food and Drug Administration approved for severe spasticity not adequately managed by oral baclofen therapy.2 We report the first ITB pump implantation during pregnancy as based on all available literature. A 23-year-old paraplegic woman was referred for treatment of lower extremity spasticity secondary to an incomplete T7 spinal cord injury sustained during a motor vehicle accident that occurred in December 1998. Having failed oral baclofen in the past, treatment options discussed were tizanidine, botulinum injections, and ITB. However, the patient became pregnant prior to implementation of a secondary treatment. As her pregnancy progressed, she experienced increased spasticity and spasticity-related pain. The patient was referred for consideration of ITB pump placement. Within 4 hours …