Tinnitus Clinical Trial
Official title:
A Feasibility Study to Assess the Effectiveness of Different Modalities of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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