| Screening | Baseline | R3 | Treatment | Follow-Up | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Visits | V0 | V1 | Â | V2 | V3 | V4 | V5 | V6 | V7 | V8 | V9 | V10 | V11 | V12 | V13 | final visit4 |
Week | Â | Week 0 | Â | 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 | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | X | X | X | X |
Otologic examination and audiological assessment | X1 | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â |
Informed Consent | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Demographic Data | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Medical History | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Documentation of Comorbidity | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Documentation of concomitant medication | X | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | X | X | X |
Physical examination | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â | X |
Vital Signs | Â | X | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â | X |
Rating Scales (Goebel&Hiller, BDI, SF 12) | Â | X2 | Â | Â | Â | Â | Â | X | Â | Â | Â | Â | X | X | X | X |
Tinnitus-Severity | Â | X | Â | X | Â | Â | Â | X | Â | Â | Â | Â | X | X | X | X |
NEO FFI, RS-11 | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
CGI | Â | X | Â | X | Â | Â | Â | X | Â | Â | Â | Â | X | X | X | X |
Neuropsychological Assessment | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â | Â |
Cortical Excitability (pTMS) | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â | Â |
Structural Neuroimaging (VBM) | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | X | Â | Â | Â |
Inclusion/Exclusion | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
Randomization | Â | Â | X | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â | Â |
rTMS Treatment | Â | Â | Â | X | X | X | X | X | X | X | X | X | X | Â | Â | Â |
Documentation of Adverse Events | Â | Â | Â | X | X | X | X | X | X | X | X | X | X | Â | Â | Â |