title: Deep brain stimulation in early Parkinson's disease: enrollment experience from a pilot trial.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors: Department of Neurology, Vanderbilt University Medical Center, Nashville, Tennessee 37232, USA. david.charles@vanderbilt.edu
authors: P D
authors: PD
authors: Charles
authors: R M
authors: RM
authors: Dolhun
authors: C E
authors: CE
authors: Gill
authors: T L
authors: TL
authors: Davis
authors: M J
authors: MJ
authors: Bliton
authors: M G
authors: MG
authors: Tramontana
authors: R M
authors: RM
authors: Salomon
authors: L
authors: L
authors: Wang
authors: P
authors: P
authors: Hedera
authors: F T
authors: FT
authors: Phibbs
authors: J S
authors: JS
authors: Neimat
authors: P E
authors: PE
authors: Konrad
mesh_terms: D000368:Aged; D046690:Deep Brain Stimulation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000628:therapy*; D018579:Patient Selection; D010865:Pilot Projects; D016037:Single-Blind Method