Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Tinnitus Clinical Trial

Official title:

Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01093872
• Other study ID #: #2008/061/A
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2010
• Last updated: December 6, 2012
• Start date: August 2008
• Est. completion date: August 2013

Study information

• Verified date: August 2012
• Source: Singapore General Hospital
• Contact: YL Lo, MD
• Phone: 63265003
• Email: lo.yew.long[@]sgh.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients with tinnitus

Exclusion Criteria:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

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.

Locations

Country	Name	City	State
Singapore	Singapore General Hospital	Singapore	Outram Road

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)	THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.	Baseline, 1,2,3 & 4weeks after treatment	No