Clinical trial NCT02269839: A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
Official title: A Feasibility Study to Assess the Effectiveness of Different Modalities of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
rTMS
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in tinnitus severity following treatment with rTMS
timeFrame: 3 months
Secondary outcomes:
measure: The number of patients willing to complete the trial
timeFrame: 3 months
measure: Confirm acceptability of trial design to participants
timeFrame: 3 months
measure: Determine success of sham intervention
timeFrame: 3 months
measure: Success of assessment methods
timeFrame: 3 months
measure: Sample size calculation
timeFrame: 3 months
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Jaydip Ray, PhD
role: PRINCIPAL_INVESTIGATOR
References: