timeline (weeks)
|
−14 (+/−1)
|
− 10 (+/− 1)
|
−6 (+/− 1)
|
0
|
+4 (+/− 1)
|
+ 12 (+/− 1)
|
+ 16 (+/− 1)
|
+ 24 (+/− 1)
|
+ 48 (+/− 1)
|
Interventions
|
BoNT test injection
|
X
| | | | | | | | |
DBS surgery
| | |
X
| | | | | | |
Testing of stimulation (side) effects
| | | |
X
| | | | | |
DBS setting/sham stimulationa
| | | |
X
| |
X
| | | |
Blind BoNT/placebo injectiona
| | | |
X
| |
X
| | | |
Unblind neurostimulation
| | | | | | | |
X
|
X
|
Randomization
| | | |
X
| | | | | |
Data set
|
Informed consent
|
X
| | | | | | | | |
Inclusion/exclusion criteria
|
X
|
X
| | | | | | | |
Medical history
|
X
| | | | | | | | |
Concurrent medication
|
X
| | | |
X
|
X
|
X
|
X
|
X
|
TWSTRS
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
Tsui Rating Scale
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
Bain Tremor Rating
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
GCI
|
X
|
X
| |
X
|
X
|
X
|
X
|
X
|
X
|
CDQ-24
|
X
| | |
X
| | | |
X
|
X
|
SF-36
|
X
| | |
X
| | | |
X
|
X
|
EQ-5D
|
X
| | |
X
| | | |
X
|
X
|
MDRS
|
X
| | |
X
| | | |
X
|
(X)
|
BDI
|
X
| | |
X
| | | |
X
|
(X)
|
BPRS
|
X
| | |
X
| | | |
X
|
(X)
|
Video recording
|
(X)
|
(X)
| |
X
|
(X)
|
(X)
|
(X)
|
X
|
X
|
Questionnaire on DBS procedure
| | |
X
| | | | | | |
Postoperative control of electrode position
| | | |
X
| | | | | |
AE
| | | | |
X
|
X
|
X
|
X
|
X
|
DBS settings
| | | |
X
|
X
|
X
|
X
|
X
|
X
|