Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Singapore General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT01093872
First received: March 24, 2010
Last updated: December 6, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Tinnitus
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS) [ Time Frame: Baseline, 1,2,3 & 4weeks after treatment ] [ Designated as safety issue: No ]
    THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.


Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients with tinnitus

Exclusion Criteria:

  • Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093872

Contacts
Contact: YL Lo, MD 63265003 lo.yew.long@sgh.com.sg

Locations
Singapore
Singapore General Hospital Recruiting
Singapore, Outram Road, Singapore, 169608
Contact: YL Lo, MD       lo.yew.long@sgh.com.sg   
Principal Investigator: YL Lo, MD         
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: YL Lo, MD National Neuroscience Institute, Singapore General Hospital
  More Information

No publications provided

Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT01093872     History of Changes
Other Study ID Numbers: #2008/061/A
Study First Received: March 24, 2010
Last Updated: December 6, 2012
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Tinnitus
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014