Pallidal neurostimulation versus botulinum toxin injections in the treatment of cervical dystonia: protocol of a randomized, sham-controlled trial (StimTox-CD)

Table 2 Synopsis of interventions and data sets (displayed for single SimTox-CD study visits)

	Screening visit/SCR	Evaluation visit/EVA	DBS surgery/DBS	Randomization visit/RAN	Follow-up visit 1/FU1	Follow-up visit 2/FU2	Follow-up visit 3/FU3	Follow-up visit 4/FU4	Follow-up visit 5/FU5
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 stimulation^a				X		X
Blind BoNT/placebo injection^a				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

^aaccording to randomized group allocation
Abbreviations (in alphabetical order): AE adverse events, BoNT Botulinum neurotoxin, BDI Beck Depression Inventory, BPRS Brief Psychiatric Rating Scale, CDQ-24 Craniocervical Dystonia Questionnaire, DBS deep brain stimulation, EQ-5D Euroquol (life quality questionnaire), GCI Global Clinical Impression Scale, MDRS Mattis Dementia Rating Scale, TWSTRS Toronto Western Spasmodic Torticollis Rating Scale, SF-36 Short Form 36 (life quality questionnaire)

ISSN: 2524-3489