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

Phase 2

Completed

• Conditions: Auditory Hallucinations
• Interventions: Procedure: continuous theta burst stimulation (cTBS); Procedure: sham cTBS

• 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

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-13
• Last Update Posted: 2013-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cTBS	continuous theta burst stimulation (cTBS)	-
Sham cTBS	sham cTBS	-

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