Table 1.
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 = results of routine clinical investigations
2 = each patient receives at V1 two versions of THI and TQ to be completed on Monday and Friday before V2
3 = randomisation
4 = Visit 14 or PTV = Premature Termination Visit