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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: University Hospital Tuebingen

Current Primary Outcome: Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations [ Time Frame: 3 weeks ]

Change of PSYRATS AH score compared to baseline after 3 weeks of treatment


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Hallucination change score (HCS) [ Time Frame: 3 and 6 weeks ]
  • Positive and Negative Symptom Scale (PANSS) [ Time Frame: 3 and 6 weeks ]
  • PSYRATS subscale for auditory hallucinations [ Time Frame: 6 weeks ]
    Change of PSYRATS AH score compared to baseline after 6 weeks of treatment


Original Secondary Outcome: Same as current

Information By: University Hospital Tuebingen

Dates:
Date Received: November 21, 2011
Date Started: May 2011
Date Completion:
Last Updated: July 13, 2013
Last Verified: July 2013