Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations
- Conditions
- Auditory Hallucinations
- Registration Number
- NCT01478880
- Lead Sponsor
- University Hospital Tuebingen
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- epilepsy
- benzodiazepines > 1,5mg lorazepam / d
- pregnancy
- metal parts in the brain
- cardiac pacemaker
- deep brain stimulation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations 3 weeks Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
- Secondary Outcome Measures
Name Time Method Hallucination change score (HCS) 3 and 6 weeks Positive and Negative Symptom Scale (PANSS) 3 and 6 weeks PSYRATS subscale for auditory hallucinations 6 weeks Change of PSYRATS AH score compared to baseline after 6 weeks of treatment
Trial Locations
- Locations (1)
University of Tübingen, Department of Psychiatry and Psychotherapy
🇩🇪Tübingen, Germany
University of Tübingen, Department of Psychiatry and Psychotherapy🇩🇪Tübingen, Germany