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

Auditory Hallucinations Clinical Trial

— TBS-H  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478880
• Other study ID #: TBS-H 1
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2011
• Last updated: July 13, 2013
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

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

Intervention

Procedure:
• continuous theta burst stimulation (cTBS)
bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4)
• sham cTBS
bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4) with the stimulation coil tilted 45°

Locations

Country	Name	City	State
Germany	University of Tübingen, Department of Psychiatry and Psychotherapy	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations	Change of PSYRATS AH score compared to baseline after 3 weeks of treatment	3 weeks	No
Secondary	Hallucination change score (HCS)		3 and 6 weeks	No
Secondary	Positive and Negative Symptom Scale (PANSS)		3 and 6 weeks	No
Secondary	PSYRATS subscale for auditory hallucinations	Change of PSYRATS AH score compared to baseline after 6 weeks of treatment	6 weeks	No