A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus

November 1, 2016 updated by: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom
        • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: theta-burst rTMS
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.
Device: rTMS
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 Names:
  • repetitive Transcranial Magnetic Stimulation
Sham Comparator: Control arm
The control (sham) stimulation will consist of stimulating with the rTMS coil held at right angles to the participants' head. This will result in no active stimulation of brain tissue but would feel similar to the patient. Each treatment session will therefore last approximately 20 minutes.
Device: rTMS
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 Names:
  • repetitive Transcranial Magnetic Stimulation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement in tinnitus severity following treatment with rTMS
Time Frame: 3 months
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of patients willing to complete the trial
Time Frame: 3 months
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
Confirm acceptability of trial design to participants
Time Frame: 3 months
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
Determine success of sham intervention
Time Frame: 3 months
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
Success of assessment methods
Time Frame: 3 months
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
Sample size calculation
Time Frame: 3 months
Determination of the number of participants required for a subsequent definitive trial aimed at demonstrating statistical significance.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheffield Teaching Hospitals NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaydip Ray, PhD, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STH15971

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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