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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