Table. Selected trials of deep brain stimulation for Parkinson’s disease.
| Trial | Evidence level | Target structure | Design | Patient characteristics | Result |
|---|---|---|---|---|---|
| Deuschl et al., 2006(3) ClinicalTrials.gov number, NCT00196911 |
Ib | STN | Multicenter, non-blinded, randomizedn n= 156 Endpoints: PDQ39; UPDRS III at 6 months |
n=78 DBS (60.5±7.4 yr, 64% m) vs. n=78 BMT (60.8±7.8 yr, 64% m) H&Y 2–5 (50% H&Y 4) Treatment with L-dopa: DBS: 13.0±5.8 yr BMT: 13.8±5.6 yr |
Superiority of DBS with respect to PDQ39 Summated score, compared at 6 months |
| EARLYSTIM Schuepbach et al. 2013 (7) ClinicalTrials.gov number, NCT00354133 |
Ib | STN | Multicenter, non-blinded, randomizedn = 251 Endpoints: PDQ39; UPDRS I–IV at 24 months |
n=124 DBS (52.9±6.6 yr, 66% m) vs n=127 BMT (52.2±6.1 yr, 77% m) Treatment with L-dopa: DBS: 4.8±3.3 yr BMT: 5.0±3.3 yr |
Superiority of DBS with respect to PDQ39 Summated score, compared at 2 years No significant difference in AE; in particular, no elevated incidence of suicide in the DBS group |
| Follet et al., 2010 (4) ClinicalTrials.gov numbers, NCT00056563 and NCT01076452 |
Ib | STN; GPi | Multicenter, randomized Complex design with randomization to BMT or DBS (STN, GPi); after 6 months of BMT, randomization to DBS in the STN or GPi n = 299 Endpoint: UPDRS III motor score at 24months |
n= 147 STN-DBS (61.9±8.7 yr, 79% m) vs. n=152 GPi-DBS (61.8±8.7 yr, 87.5% m) Treatment with L-dopa: STN-DBS: 11.1 ± 5 yr GPi-DBS: 11.5 ± 5.4 yr |
Significant improvement of motor scores in both groups compared to BMT No superiority of either STN- or GPi-DBS Improvement of PDQ39 iin both groups at 24 months Trend toward improvement of depression with GPi-DBS and worsening with STN-DBS (BDI) |
| NSTAPS Oderkerken et al., 2013 (5) www.controlled-trials.com, number ISRCTN85542074 |
Ib | STN; GPi | Multicenter, randomized n = 128 |
n= 63 STN-DBS (60.9 ± 7.6 yr) n= 65 GPi-DBS (59.1 ± 7.8 yr) H&Y 2.5 (0–4) Treatment with L-dopa: STN-DBS: 9.5 ± 5.6 yr GPi-DBS: 9.0 ± 3.9 yr |
No difference between groups in functional health assessed at 1 year STN-DBS lessens clinical disability and motor off-phases GPi-DBS reduces dyskinesia more effectively at 1 yr No difference between groups with respect to AE |
AE, adverse event(s); BDI, Beck Depression Inventory; BMT, best medical treatment; DBS, deep brain stimulation; GPi, globus pallidus internus; H&Y, Hoehn and Yahr disease stage (I–V); L-dopa, levodopa; m, male; PDQ39, Parkinson’s Disease Questionnaire; STN, subthalamic nucleus; UPDRS III, motor score of the Unified Parkinson’s Disease Rating Scale ; yr, years