Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

NCT ID: NCT01093872

Last Updated: 2012-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-08-31

Brief Summary

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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

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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.

Conditions

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Tinnitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with tinnitus

Exclusion Criteria

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

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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YL Lo, MD

Role: PRINCIPAL_INVESTIGATOR

National Neuroscience Institute, Singapore General Hospital

Locations

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Singapore General Hospital

Singapore, Outram Road, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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YL Lo, MD

Role: CONTACT

Phone: 63265003

Email: [email protected]

Facility Contacts

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YL Lo, MD

Role: primary

Other Identifiers

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#2008/061/A

Identifier Type: -

Identifier Source: org_study_id