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Table 1 Study Plan

From: Design of a placebo-controlled, randomized study of the efficacy of repetitive transcranial magnetic stimulation for the treatment of chronic tinnitus

  Screening Baseline R3 Treatment Follow-Up
Visits V0 V1   V2 V3 V4 V5 V6 V7 V8 V9 V10 V11 V12 V13 final visit4
Week   Week 0   Week 1 Week 2 Week 3 Week 10 Week 26/PTV
Day   - 11 to -9   1 2 3 4 5 8 9 10 11 12 17 – 19 66–68 180 – 182
Rating Scales (THI) X1 X2       X      X X X X
Otologic examination and audiological assessment X1              X   
Informed Consent X                
Demographic Data X                
Medical History X                
Documentation of Comorbidity X X               
Documentation of concomitant medication X X            X X X X
Physical examination   X            X    X
Vital Signs   X   X          X    X
Rating Scales (Goebel&Hiller, BDI, SF 12)   X2       X      X X X X
Tinnitus-Severity   X   X     X      X X X X
NEO FFI, RS-11   X               
CGI   X   X     X      X X X X
Neuropsychological Assessment   X            X    
Cortical Excitability (pTMS)   X            X    
Structural Neuroimaging (VBM)   X            X    
Inclusion/Exclusion   X               
Randomization    X              
rTMS Treatment     X X X X X X X X X X    
Documentation of Adverse Events     X X X X X X X X X X    
  1. 1 = results of routine clinical investigations
  2. 2 = each patient receives at V1 two versions of THI and TQ to be completed on Monday and Friday before V2
  3. 3 = randomisation
  4. 4 = Visit 14 or PTV = Premature Termination Visit