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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: Age over 18 years • Persistent unilateral or bilateral subjective tinnitus Exclusion Criteria: - Epilepsy - Severe or profound hearing loss - Patients taking vestibular sedatives, antipsychotic, anxiolytic, antiepileptic and ototoxic medications. - Ear infections or discharge - History of ear surgery - History of noise trauma - Excess alcohol consumption - Meniere's disease - VIII nerve tumour - Bells palsy - Ramsay-Hunt Syndrome - Post-meningitis hearing loss and tinnitus - Active psychiatric conditions - Congenital or syndromal associations |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in tinnitus severity following treatment with rTMS | The primary outcome measure for the definitive trial is the improvement in tinnitus severity following treatment with theta burst rTMS compared to control as demonstrated by change in Tinnitus Functional Index (TFI) scores. Assessed on completion of treatment and at 1 week and 1 month following. | 3 months | No |
Secondary | The number of patients willing to complete the trial | Feasibility outcome measures relevant to this feasibility study are those which will enable the investigators to successfully complete a full study in the future. One issue is whether sufficient participants could be recruited to run future trials. This will be assessed through measuring the recruitment and retention rate of this feasibility study. | 3 months | No |
Secondary | Confirm acceptability of trial design to participants | To enable successful completion of future larger evaluation of patients views on the study design and interventions through simple feedback questionnaires will be performed. | 3 months | No |
Secondary | Determine success of sham intervention | To confirm the use and suitability of the control intervention for future trials the investigators will be evaluating whether patients are aware if receiving sham or real rTMS | 3 months | No |
Secondary | Success of assessment methods | To evaluate the chosen method and frequency of data collection to evaluate its use for future trials. Assessed by appropriate completion and return of questionnaires. | 3 months | No |
Secondary | Sample size calculation | Determination of the number of participants required for a subsequent definitive trial aimed at demonstrating statistical significance. | 3 months | No |
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