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Status unknownNCT01093872Updated Dec 10, 2012

Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

An interventional study of Repetitive Transcranial Magnetic Stimulation (rTMS) in Tinnitus, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-12-10.

Sponsored by Singapore General Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
21 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Tinnitus

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03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's planned enrollment of 100 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All patients with tinnitus

Exclusion criteria

Exclusion Criteria:

  • Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Interventions

  • DeviceRepetitive 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.

06

What researchers measure

Primary outcomes

  1. Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)

    THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.

    Time frame: Baseline, 1,2,3 & 4weeks after treatment

07

Study locations

1 of 1 sites recruiting
  • Singapore General Hospital
    Singapore, Outram Road 169608, Singapore
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01093872
Lead sponsor
Singapore General Hospital
Responsible party
Sponsor
First posted
Mar 26, 2010
Start date
Aug 2008
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Dec 10, 2012

Study contacts

YL Lo, MD
Contact
lo.yew.long@sgh.com.sg
63265003
YL Lo, MD
principal investigator · National Neuroscience Institute, Singapore General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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