A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

• NCT number: NCT02269839
• Study type: Interventional
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Completion date: June 2016