Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations

Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations

First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.

Inclusion Criteria:

• auditory hallucinations at least once a week
• Schizophrenia (DSM-IV)
• stable treatment setting (in- or out-patient)
• no change of antipsychotics during and at least 1 week before treatment initiation

Exclusion Criteria:

• epilepsy
• benzodiazepines > 1,5mg lorazepam / d
• pregnancy
• metal parts in the brain
• cardiac pacemaker
• deep brain stimulation