Table 1.
Clinical trials assessing STN DBS
| Author (year) | Age (SD) at surgery | Disease duration at time of surgery in years (SD) | ON/OFF assessments? | Washout period? | Conclusion(s) |
|---|---|---|---|---|---|
| Charles et al. (2014)36 | 60 (6.8) | 2.2 (1.4)c | MedOFF/ON, StimOFF/ON | 7 days for meds and stim | No difference in UPDRS (total) or in part III from STN DBS compared with medication controls over 2 years. |
| Weaver et al (2017)24 | 65.6 (7.6) | >5 | None | N/A | DBS (STN or GPi) associated with increased survival compared with matched controls. |
| Schuepbach et al (2013)4 and Lhommee et al (2018)125 | 52.9 (6.6) | 7.3 (3.1) | MedOFF/ON, StimOFF/ON | 12‐48 hours for meds, 2 hours for stim | PDQ‐39, UPDRS‐II, ‐III, and ‐IV improved compared with medication control group; PDQ‐39 also improved compared with baseline in DBS group. Improved behavioral outcomes in DBS group compared with medical therapy alone. |
| Yamada et al (2009)29 | 65.7 (7.8) | 9.8 (5.6) | MedOFF/ON, StimON | 12 hours for meds | Shorter disease duration at surgery associated with better postoperative S&E ADLs. |
| Dafsari et al (2017)30 | 53.2‐72.3§ | 10.5‐11.1d | MedON, StimON | N/A | PDQ‐8 improved with STN DBS over 5 months, with larger effect size associated with younger age at time of surgery. |
| Dafsari et al (2018)126 | 62.3 (7.8) | 10.9 (4.8) | MedON, StimON | N/A | Improvement in nonmotor symptom scale over 2 years (compared with baseline) with bilateral STN DBS. |
| Toft et al (2011)127 | 60.3 (7.8) | 11.0 (4.8) | MedOFF/ON, StimON | Not reported | Annual increase of 3.2 points on UPDRS‐III scale after STN DBS surgery and a survival of 97% and 90% at 3 and 5 years postoperation, respectively. |
| Ngoga et al (2014)23 | 60 (53‐63)a | 11.0 (8.8‐13.0)a | None | N/A | Longer survival and less likely to enter a residential care home with STN DBS compared with medical management. |
| Trager et al (2016)33 | 61.6 (8.0) | 11.0 (3.5) | MedOFF, StimON/OFF | 12‐72 hours for meds, 60 minutes for stim | Improved UPDRS‐III and reduced beta‐band power with StimOFF after 12 months of DBS compared with baseline. |
| Tagliati et al (2010)21 | 60 (12) | 12 (4) | MedOFF/ON, StimOFF/ON | ∼12 hours for meds, 30 minutes for stim | UPDRS‐III stable when off medication at baseline compared with off medication and off stimulation over 3‐4 years. |
| Aviles‐Olmos (2014)128 | 52.8 (10.1) | 12.3 (4) | MedOFF/ON, StimON | 12 hours for meds | Over 8 years, STN DBS improved UPDRS‐III versus baseline when off medication, and on medication, UPDRS‐III scores declined over time. |
| Merola et al (2012)25 | 54.7‐65.5d | 12.5‐19.2d | MedOFF/ON, StimOFF/ON | Overnight for meds, 1 hour for stim | Lower incidence of medication‐ or stimulation‐resistant symptoms in young‐onset PD compared with non‐young‐onset PD over 5 years postsurgery. |
| Hilker et al (2005)22 | 59.8 (7.2) | 12.6 (4.2) | MedOFF/ON, StimON | 12 hours for meds | No change in rate of decline of F‐dopa uptake in caudate nucleus or putamen in association with STN DBS compared with rates in the literature (no matched medication group in study). |
| Merola et al (2014)31 | 60.11 (5.62) | 12.94 (2.15) | MedOFF/ON, StimOFF/ON | 12 hours for meds, 1 hour for stim | Decreased off time and disability from dyskinesia with STN DBS but no difference in UPDRS‐III between DBS and medication control group over about 6 years. |
| Lezcano et al (2016)129 | 61.3 (7.4) | 13.2 (5.7) | MedOFF/ON, StimON | Not reported | Improved UPDRS‐II and ‐III and S&E ADL scores over 5 years compared with baseline off medication. Worse UPDRS‐III versus baseline when on medication. |
| Castrioto et al (2011)26 | 52.9 (7.9) | 13.4 (4.8) | MedOFF/ON, StimOFF/ON | Overnight for meds, 1 hour for stim | UPDRS‐III improved compared with baseline when assessed off medication at 10 years. |
| Fasano et al (2010)130 | 56.9 (7.2) | 13.7 (4.8) | MedOFF/ON, StimON | Overnight for meds | Over 8 years, STN DBS improved UPDRS‐III versus baseline but not relative to 5 years postsurgery, and UPDRS‐II significantly worsened from year 5 to year 8. |
| Rocha et al (2014)131 | 60 (8) | 14 (range, 5‐48) | None | N/A | Survival of 99% and 94% at 3 and 5 years, respectively, with DBS (mixed GPi and STN). |
| Rodriguez‐Oroz et al (2005)20 | 59.8 (9.8) | 14.1 (5.9) | MedOFF/ON, StimOFF/ON | ∼12 hours for meds, 1‐2 hours for stim | UPDRS‐II and UPDRS‐III improved compared with baseline when assessed off medication, on stimulation over 3‐4 years. |
| Krack et al (2003)18 | 55 (7.5) | 14.6 (5.0) | MedON/OFF, Stim ON | 8‐12 hours for meds | UPDRS‐III and S&E improved compared with baseline when assessed off medication over 5 years. |
| Pal et al (2017)34 and Pal et al (2018)35 | ≈ 72 | ≈14.6 | MedOFF/ON, StimON but not specifically reported | Overnight for meds | Increased α‐synuclein density scores, equivalent loss of pigmented nigral neurons, and equivalent putaminal dopamine and dopamine metabolite whole‐tissue content with STN DBS compared with medically treated controls. |
| Hilker et al (2003)132 | 61.8 (4.9) | 15.3 (4.4) | MedOFF, StimON/OFF | 12 hours, allowed 1 adjunctive dose | Using [11C]raclopride PET, no change in binding between on and off stimulation. |
| Bang Henriksen et al (2016)133 | 59.7 (7.7) | 15.7 (6.0) | None | N/A | Postsurgery, 70% of STN DBS subjects survived 10 years (25 total years’ disease duration). |
| Zibetti et al (2011)134 | 61.4 (6.0) | 16.4 (4.9) | MedOFF/ON, StimOFF/ON | Overnight for meds, 1 hour for stim | Over 9 years, STN DBS improved UPDRS‐III versus baseline without improvement in UPDRS‐II and some with cognitive decline. |
| Rodriguez‐Oroz et al (2004)19 | 62 | “Advanced PD” | MedOFF, StimON/OFF | Overnight for meds, 2 hours for stim | UPDRS‐II and UPDRS‐III improved compared with baseline when assessed off medication, on stimulation over 4 years. |
| Lilleeng et al (2014)32 | 64 (6) | 18 (9)b | MedON, StimON | N/A | No change in time to death or in rate of decline by UPDRS‐III when assessed on medication and on stimulation over several years compared with age‐matched group on medication alone. |
| Strafella et al (2003)135 | ≈59 (9.0) | 32.6 (5.9)b | MedON, StimON/OFF | No stim overnight | Using [11C]raclopride PET, no change in binding between on and off stimulation. |
a
Median (quartiles).
b
Reported as UPDRS‐III on medication (SD).
c
Measured in years from start of medication use, not time since diagnosis.
d
Three groups compared, with means of youngest and oldest groups displayed.
S&E ADLs, Schwab and England activities of daily living.