Effect of rTMS on Resting State Brain Activity in Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

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.
    

Intervention name(s): Sham rTMS - Sham repetitive transcranial magnetic stimulation; Active 1 Hz rTMS - Active repetitive transcranial magnetic stimulation delivered at 1 Hz frequency; Active 10 Hz rTMS - active repetitive transcranial magnetic stimulation delivered at 10 Hz frequency
Intervention type(s): Device; Device; Device
Intervention description(s): Sham rTMS will be delivered using a commercially available sham coil and targeted to the same brain site in the temporal lobe and in a manner identical to that for active rTMS except that scalp electrodes are used to stimulate the temporalis muscle electrically during sham stimulation to replicate the feel of active TMS.; Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 1 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.; Active rTMS will be targeted either to the mid-superior temporal gyrus opposite the ear with loudest tinnitus or to the same region in the left hemisphere if no asymmetry in tinnitus is present. 10 Hz active rTMS will be delivered at 110% of motor threshold (MT) for a total of 1800 magnetic pulses per session, 4 sessions per week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tinnitus; Transcranial Magnetic Stimulation; TMS; rTMS