TinnitusNCT02269839
A Feasibility Study Assessing the Effectiveness of rTMS in Tinnitus
A study testing rTMS in people with Tinnitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Persistent unilateral or bilateral subjective tinnitus
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire
About this study
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.
Read more
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called repetitive Transcranial Magnetic Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| theta-burst rTMS | Active comparator | 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. Receives: Device: rTMS |
| Control arm | Sham comparator | 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. Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (5)
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.
Measured: 3 months
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.
Measured: 3 months
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
Measured: 3 months
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.
Measured: 3 months
Sample size calculation
Determination of the number of participants required for a subsequent definitive trial aimed at demonstrating statistical significance.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jaydip Ray, PhD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269839
- Sponsor's protocol ID
- STH15971
- Status last verified
- Nov 2016
- First submitted
- 27 Jun 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Assess the Effectiveness of Different Modalities of Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
- ClinicalTrials.gov ID
- NCT02269839
- Acronym / sponsor ID
- STH15971
- Conditions
- Tinnitus
- Keywords
- Tinnitus, rTMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| theta-burst rTMS | Active comparator | Device: rTMSActive 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. |
| Control arm | Sham comparator | Device: rTMSThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 18 years
- Persistent unilateral or bilateral subjective tinnitus
Key exclusion criteria (14 listed)
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSAlso: repetitive Transcranial Magnetic StimulationActive 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 | Control arm, theta-burst rTMS |
Primary outcome
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.
5 secondary outcomes
The number of patients willing to complete the trial
Time frame: 3 months
Confirm acceptability of trial design to participants
Time frame: 3 months
Determine success of sham intervention
Time frame: 3 months
Success of assessment methods
Time frame: 3 months
Sample size calculation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaydip Ray, PhD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Tinnitus, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in tinnitus severity following treatment with rTMS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.