Background Recent evidence suggests that deep brain stimulation of the subthalamic nucleus (STN-DBS) may have a disease modifying effect in early Parkinson's disease (PD). A randomised, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable.
Objectives/methods 15 of 30 early PD patients were randomised to receive STN-DBS implants in an institutional review board approved protocol. Operative technique, location of DBS leads and perioperative adverse events are reported. Active contact used for stimulation in these patients was compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon.
Results 14 of the 15 patients did not sustain any long term (>3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior −1.1±1.7 mm, lateral 10.7±1.7 mm and superior −3.3±2.5 mm (anterior and posterior commissure coordinates). This location is statistically no different (0.77 mm, p>0.05) than the optimal contact used in the treatment of 47 advanced PD patients.
Conclusions The perioperative adverse events in this trial of subjects with early stage PD are comparable with those reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomised, surgical versus best medical therapy trial for the early treatment of PD.
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Funding This study was supported by the Vanderbilt CTSA grant 1 UL1 RR024975 from the National Center for Research Resources, NIH, Medtronic Inc, NIH-NIBIB 1 R01-EB006136 and by gifts from private donors.
Competing interests Vanderbilt University has received income from grants and contracts with Allergan and Medtronic for research led by PDC. PDC has received income from Allergan and Medtronic for education and consulting services. PK has received income from grants and contracts with Medtronic Neurological Inc and FHC Inc for research.
Ethics approval This study was conducted with the approval of Vanderbilt IRB 040797.
Provenance and peer review Not commissioned; externally peer reviewed.