Repetitive Transcranial Magnetic Stimulation for Chronic Subjective Tinnitus
Condition: Tinnitus, Subjective
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Therapy of subjective chronic primary tinnitus could be challenging. Repetitive transcranial
      magnetic stimulation (rTMS) is currently being tested for suppressing the symptoms. However,
      effect of stimulation remains controversial. The aim was to uncover real effect of rTMS
      stimulation for tinnitus treatment. There will be three groups, stimulation group, sham
      stimulation group and controlled group with medicament treatment. The investigators assume
      that combination of rTMS stimulation of dorsolateral prefrontal cortex and primary auditory
      cortex at both sides will be more efficient. The investigators considered a 10% improvement
      in the tinnitus questionnaire score and in the tinnitus masking to be clinically relevant.
    

Detailed description: 
      Adult patients suffering from chronic subjective non-pulsatile primary unilateral or
      bilateral tinnitus for at least 6 months will be included in the study. Patients will be
      randomly assigned using a random number generation randomization method into rTMS stimulation
      group (group 1), sham stimulation group (group 2) and group with medicament therapy only
      (group 3). Dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor
      threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will
      be stimulated in patients in rTMS stimulation group for 5 consecutive days. Both the patients
      and outcome assessor were blinded to the intervention group in which the patients (rTMS and
      shame stimulation group) belonged to. Medicament therapy in group 3 will consist of ginkgo
      biloba extract EGb 761 once a day for 6 months. There will be no medicament therapy for
      tinnitus in group 1 and 2. Tinnitus reaction questionnaire (TRQ), tinnitus handicap
      questionnaire (THQ), tinnitus handicap inventory (THI), Beck Depression Inventory (BDI),
      pure-tone audiometry with Fowler scoring of hearing loss and tinnitus analysis will be used
      for evaluation of tinnitus in all patients. Data will be recorded on the day patient is
      included in the study, during follow-up after 1 month and 6 months. Descriptive statistics,
      such as the arithmetic mean, standard deviation, and absolute and relative frequency tables,
      will be used for data processing. The Pearson's chi-squared test, Fisher's exact test,
      Kruskal-Wallis test and analysis of variance will be used for comparison. The statistical
      tests will be assessed using a significance level of 5%.
    

Intervention name(s): Repetitive Transcranial Magnetic Stimulation; Sham stimulation; Ginkgo Biloba Extract
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Patients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm.; Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.; Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is designed as interventional, blinded, randomized, controlled trial with three parallel arms
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic tinnitus; repetitive transcranial magnetic stimulation; hypacusion; depression; treatment; placebo; medication therapy