Treatment of Tinnitus Using Theta Burst Based Repetitive Transcranial Magnetic Stimulation-A Single Blinded Randomized Control Trial

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.