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

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

  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 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
  1. aaccording to randomized group allocation
  2. 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)