A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Tinnitus is a common problem which can have a severe impact on quality of life and for which
      there is no truly successful treatment available.

      Repetitive transcranial magnetic stimulation (rTMS) is a method of stimulating the brain
      through the application of a magnetic field in a series of rapid pulses and may be a valuable
      treatment for patients with tinnitus.

      The overall aim of this research is to see if patients with tinnitus benefit from treatment
      with rTMS, and in particular whether one type (continuous theta burst) is more effective than
      other variations of rTMS. Prior to developing a definitive study to address this area a
      feasibility study needs to be performed.

      The proposed feasibility study aims to determine outcomes necessary to enable development of
      a definitive study in the future.

      40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control
      group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on
      5 consecutive days.
    

Detailed description: 
      Tinnitus is a common problem and can have a severe impact on quality of life. At present
      there is no truly successful treatment available. Repetitive transcranial magnetic
      stimulation (rTMS) is a method of stimulating the brain through the application of a magnetic
      field in a series of rapid pulses. Applying it to the areas of the brain thought to be
      responsible for tinnitus may offer a valuable treatment for patients.

      The overall aim of this research is to see if patients with tinnitus benefit from treatment
      with rTMS, and in particular whether one type (continuous theta burst) is more effective than
      other variations of rTMS. Prior to developing a definitive study to address this area a
      feasibility study needs to be performed.

      The proposed feasibility study aims to determine outcomes necessary to enable development of
      a definitive study in the future. Particularly to ensure adequate recruitment will be
      possible and to confirm the acceptability of the study design to participants. We will assess
      the success of our chosen placebo intervention and blinding method. The variance in change in
      tinnitus level following treatment will enable a sample size calculation to be performed for
      use in future studies.

      40 patients suffering with idiopathic tinnitus will be randomised into 2 groups, a control
      group receiving a sham treatment, and an active treatment group receiving theta-burst rTMS on
      5 consecutive days. The effect of treatment will be assessed through the use of the Tinnitus
      Functional Index an existing validated tinnitus questionnaire. Feasibility outcomes will be
      assessed through monitoring retention and recruitment rates and the use of questionnaires
      related to feasibility outcomes
    

Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): Active treatment will consist of sessions of continuous theta-burst rTMS on consecutive days for 5 days. This will be delivered with a circular coil to the temporal scalp region overlying the auditory cortex, contralateral to the symptomatic side in unilateral tinnitus and to the left side in bilateral tinnitus. The treatment protocol will consist of treatment at 80% of individual motor threshold (established at the first treatment session) for 600 pulses of 40 seconds duration, which will be repeated after 15 minutes. Each patient will receive 1200 pulses per day.
Other intervention name(s): repetitive Transcranial Magnetic Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tinnitus; rTMS