Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations — TBS-H  

Auditory Hallucinations Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Auditory Hallucinations
• Hallucinations

• NCT number: NCT01478880
• Study type: Interventional
• Source: University Hospital Tuebingen
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Completion date: July 2013