Abstract

Objectives: This presentation describes a Phase II clinical trial that was conducted to assess transcranial magnetic stimulation (TMS) as a treatment for chronic tinnitus. (1) Interpret the results of this clinical trial. (2) Describe the issues that need to be addressed before TMS can be implemented clinically as a treatment for tinnitus. Methods: This is a randomized, subject and clinician/observer blind, placebo-controlled parallel-group clinical trial of repetitive TMS (rTMS) for chronic tinnitus that was conducted from January 2011 to December 2014 at Portland VA Medical Center. 60 subjects (average age 61.2 years) who experienced chronic tinnitus for 1 year or longer were randomly assigned to receive either active rTMS treatment or placebo treatment to either the left or right side of the head. Subjects received 2000 pulses of 1 Hz rTMS therapy daily on 10 consecutive work days. The primary outcome measure is the Tinnitus Functional Index (TFI), a 25-item questionnaire that assesses tinnitus severity. Independent variables: Beck Depression Inventory score; State Anxiety Inventory score. Preliminary analysis: Change in TFI score from baseline at 6 post-treatment time points. Results: Fifteen of 30 subjects in the active rTMS group exhibited significant improvement in TFI score that persisted for 6 months posttreatment. Seven of 30 subjects in the placebo rTMS group exhibited significant improvement in TFI score. Conclusions: While rTMS demonstrates potential as a treatment option for tinnitus patients, additional clinical trials should be conducted to confirm the efficacy of this method.

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