Objective: To determine whether theta burst repetitive transcranial magnetic stimulation is an effective treatment for chronic tinnitus compared with a control stimulus.
Study design: A two-arm, single-blind, randomized controlled trial comparing an active treatment group to a placebo control group.
Setting: Neurotology department of a tertiary referral center.
Patients: Forty new and existing patients with chronic unilateral or bilateral tinnitus were recruited from specialist hearing and balance clinics.
Interventions: The subjects were randomized into two groups representing the treatment and sham subcategories. Two 40 second trains, 15 minutes apart of transcranial stimulation was provided using a super rapid stimulator (2.2. Tesla, Magstim Inc., Wales, UK) using a circular delivery coil. Treatment was provided over 5 consecutive days.
Main outcome measure: Tinnitus functional index (TFI) scores were recorded before treatment, immediately after treatment, 2 weeks, and at 4 weeks following treatment and compared.
Results: TFI scores were analyzed using the Shapiro-Wilk test and found to be normally distributed. A paired Student t test was then performed. Both the active treatment group and control group had a significant improvement in their TFI scores following treatment; however, there was no significant difference between active treatment and sham treatment groups.
Conclusion: This study demonstrated a significant placebo effect following treatment with sham therapy and may suggest that repetitive transcranial magnetic stimulation does not have a therapeutic use in treating chronic tinnitus.