Effect of rTMS on Resting State Brain Activity in Tinnitus

Not Applicable

Completed

Conditions: Tinnitus

Interventions: Device: Sham rTMS - Sham repetitive transcranial magnetic stimulation
Device: Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency
Device: Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency

Registration Number: NCT00926237

Lead Sponsor: University of Arkansas

Brief Summary: One out of every five people experiences tinnitus (a ringing, buzzing, or roaring sound in the ear) ranging from mild to severe impairment. To date, there are no effective therapies available that have been shown to decrease tinnitus awareness. The purpose of this study is to evaluate a treatment option for tinnitus that uses a technique called Repetitive Transcranial Magnetic Stimulation (rTMS), which could prove to be an effective means of alleviating or reducing the symptoms of tinnitus.

Detailed Description: Up to 60 subjects, including males and females ages 19-89 years old and of all races, and with tinnitus severe enough to seek medical attention, will be enrolled in this study. All participants must be evaluated or have documentation of being evaluated prior to beginning therapy with rTMS in order to confirm eligibility and to rule out any medically treatable causes of tinnitus. An MRI scan of the head may or may not be required, depending upon the results of this evaluation, in order to rule out specific middle ear pathologies.

This study will require participation in at least three weeks (4 weekdays per week) of rTMS sessions, including two active weeks and a sham (or placebo) week. There will be a three week washout period following each treatment week. At the completion of the three treatment weeks, subjects who have noticed an improvement in their tinnitus will have the option of participating in a maintenance rTMS program providing up to 8 additional weeks of treatment.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sham followed by active 1Hz, then active 10Hz rTMS	Sham rTMS - Sham repetitive transcranial magnetic stimulation	Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Sham followed by active 10Hz and active 1Hz rTMS	Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency	Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Sham followed by active 1Hz, then active 10Hz rTMS	Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency	Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Sham followed by active 10Hz and active 1Hz rTMS	Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency	Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Sham followed by active 1Hz, then active 10Hz rTMS	Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency	Subjects assigned to this arm received sham rTMS followed by active rTMS at 1Hz and then active rTMS at 10 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.
Sham followed by active 10Hz and active 1Hz rTMS	Sham rTMS - Sham repetitive transcranial magnetic stimulation	Subjects assigned to this arm received sham rTMS followed by active rTMS at 10 Hz and then active rTMS at 1 Hz. Each treatment consisted of a four-day trial with no less than 21 days separating each condition. Subjects receive sham stimulation first to prevent carry forward effects of the active treatment condition into the sham condition.

Primary Outcome Measures

Name	Time	Method
Change From Baseline on the Analogue Rating of Tinnitus Awareness.	from baseline to: day 6 (sham), day 25 (sham w/o), day 29 (1st active TX), day 50 (1st active w/o), day 50 (2nd active TX), day 76 (2nd active w/o).	Change from baseline on the daily analogue rating of tinnitus awareness. Analogue ratings are a validated self report instrument assessing subjects awareness of tinnitus in daily life. Possible scores range from 0 (no tinnitus) to 100 (painfully loud tinnitus). Change equals the average rating for a given treatment week or washout period minus the average rating over three baseline assessments.

Secondary Outcome Measures