Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Primary Purpose
Tinnitus
Status
Unknown status
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation (rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Tinnitus
Eligibility Criteria
Inclusion Criteria:
- All patients with tinnitus
Exclusion Criteria:
- Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
Sites / Locations
- Singapore General HospitalRecruiting
Outcomes
Primary Outcome Measures
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)
THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01093872
First Posted
March 24, 2010
Last Updated
December 6, 2012
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01093872
Brief Title
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Official Title
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tinnitus Inventory Handicap scoring & Visual Analogue Scale (VAS)
Description
THI and VAS is measure before the treatment and weekly for 4 weeks after the treatment.
Time Frame
Baseline, 1,2,3 & 4weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with tinnitus
Exclusion Criteria:
Patients with contraindications to TMS: pacemaker, intracranial surgery, implants and seizures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
YL Lo, MD
Phone
63265003
Email
lo.yew.long@sgh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YL Lo, MD
Organizational Affiliation
National Neuroscience Institute, Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore General Hospital
City
Singapore
State/Province
Outram Road
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YL Lo, MD
Email
lo.yew.long@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
YL Lo, MD
12. IPD Sharing Statement
Learn more about this trial
Repetitive Transcranial Magnetic Stimulation for Tinnitus Treatment
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