Table 1

Study Plan

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

Landgrebe et al. BMC Psychiatry 2008 8:23   doi:10.1186/1471-244X-8-23