Ignite Creation Date:
2024-05-05 @ 10:24 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01093872
Status:
UNKNOWN
Last Update Posted:
2012-12-10
First Post:
2010-03-24
Brief Title:
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Sponsor:
Singapore General Hospital
Organization:
Singapore General Hospital
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Status:
UNKNOWN
Status Verified Date:
2012-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 stimuliday 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
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 stimuliday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None