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Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01093872
Enrollment
100
Registered
2010-03-26
Start date
2008-08-31
Completion date
2013-08-31
Last updated
2012-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus

Brief 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.

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.

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.

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* All patients with tinnitus

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)Baseline, 1,2,3 & 4weeks after treatmentTHI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.

Countries

Singapore

Contacts

Primary ContactYL Lo, MD
lo.yew.long@sgh.com.sg63265003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026