Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
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|ClinicalTrials.gov Identifier: NCT01093872|
Recruitment Status : Unknown
Verified August 2012 by Singapore General Hospital.
Recruitment status was: Recruiting
First Posted : March 26, 2010
Last Update Posted : December 10, 2012
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Device: Repetitive Transcranial Magnetic Stimulation (rTMS)||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment|
|Study Start Date :||August 2008|
|Estimated Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||August 2013|
- Device: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093872
|Contact: YL Lo, MDfirstname.lastname@example.org|
|Singapore General Hospital||Recruiting|
|Singapore, Outram Road, Singapore, 169608|
|Contact: YL Lo, MD email@example.com|
|Principal Investigator: YL Lo, MD|
|Principal Investigator:||YL Lo, MD||National Neuroscience Institute, Singapore General Hospital|