TinnitusNCT01093872
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Tinnitus, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
In this study, we perform an open-label rTMS over the left AC on patients with tinnitus. Outcome measures will be evaluated statistically. The results will be instrumental in deciding the efficacy of this technique in a local patient group. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Tinnitus
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2008to Aug 2013
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with tinnitus
Who cannot join
- Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, Outram Road, 169608
YL Lo, MD, lo.yew.long@sgh.com.sg
YL Lo, MD
About this study
In this study, we perform an open-label rTMS over the left AC on patients with tinnitus. Outcome measures will be evaluated statistically. The results will be instrumental in deciding the efficacy of this technique in a local patient group.
Read the detailed description
Tinnitus is a subjective auditory perception of sounds or noise not triggered by external auditory stimuli, affecting millions of people worldwide. To date, pharmacological and physical/ behavioural treatments in severe cases are generally unsatisfactory. Functional brain imaging changes associated with tinnitus include hyperactivity of discrete temporoparietal regions, including both the primary auditory cortex (AC) and the secondary, or associative cortex. High-frequency rTMS (10 Hz or more) applied on the scalp overlying the hyperactive left AC produced an intense tinnitus attenuation.
Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC. A high number of stimuli/day were applied because of the previously suggested dose dependency of tinnitus alleviation by rTMS. Furthermore, the use of such relatively high intensity assured the stimulation of most of the target region, even in the case of mismatch between the scalp position and the underlying anatomy, which can be expected using the International EEG system as anatomical reference for TMS stimulation.
Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions. Tinnitus rating will be performed weekly.
Tinnitus is rated by a 0-100 Visual Analogue Scale (VAS), where 0 is wellness and 100 the worst possible tinnitus related discomfort. In addition, our validated Tinnitus Inventory scoring will be administered. Audiometry and otoscopy will be performed at enrolment and at the end of the study. Tinnitus, and acoustic evaluations are then collected by experimenters blind to the type of rTMS applied.
Standard statistical methods (SPSS for Windows) will be used to perform comparisons.
- Conditions
- Tinnitus
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS)
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions
Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)
THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.
Measured: Baseline, 1,2,3 & 4weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
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.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YL Lo, MD, Principal investigator, National Neuroscience Institute, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093872
- Sponsor's protocol ID
- #2008/061/A
- Status last verified
- Aug 2012
- First submitted
- 24 Mar 2010
- Last updated
- 10 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
- ClinicalTrials.gov ID
- NCT01093872
- Acronym / sponsor ID
- #2008/061/A
- Conditions
- Tinnitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Mar 2010 (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.
In this study, we perform an open-label rTMS over the left AC on patients with tinnitus. Outcome measures will be evaluated statistically. The results will be instrumental in deciding the efficacy of this technique in a local patient group.
Detailed description
Tinnitus is a subjective auditory perception of sounds or noise not triggered by external auditory stimuli, affecting millions of people worldwide. To date, pharmacological and physical/ behavioural treatments in severe cases are generally unsatisfactory. Functional brain imaging changes associated with tinnitus include hyperactivity of discrete temporoparietal regions, including both the primary auditory cortex (AC) and the secondary, or associative cortex. High-frequency rTMS (10 Hz or more) applied on the scalp overlying the hyperactive left AC produced an intense tinnitus attenuation.
Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC. A high number of stimuli/day were applied because of the previously suggested dose dependency of tinnitus alleviation by rTMS. Furthermore, the use of such relatively high intensity assured the stimulation of most of the target region, even in the case of mismatch between the scalp position and the underlying anatomy, which can be expected using the International EEG system as anatomical reference for TMS stimulation.
Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions. Tinnitus rating will be performed weekly.
Tinnitus is rated by a 0-100 Visual Analogue Scale (VAS), where 0 is wellness and 100 the worst possible tinnitus related discomfort. In addition, our validated Tinnitus Inventory scoring will be administered. Audiometry and otoscopy will be performed at enrolment and at the end of the study. Tinnitus, and acoustic evaluations are then collected by experimenters blind to the type of rTMS applied.
Standard statistical methods (SPSS for Windows) will be used to perform comparisons.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with tinnitus
Key exclusion criteria (1 listed)
- Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS)Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC. | Device | – |
Primary outcome
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)
Time frame: Baseline, 1,2,3 & 4weeks after treatment
THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2012.
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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.
YL Lo, MD principal investigator
National Neuroscience Institute, Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS) in people with Tinnitus, run by Singapore General Hospital at 1 site in Singapore.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Dec 2012. 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 Singapore. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YL Lo, MD (63265003, lo.yew.long@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS) (time frame: Baseline, 1,2,3 & 4weeks after treatment). 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 10 Dec 2012.