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

July 13, 2013 updated by: Christian Plewnia, MD, University Hospital Tuebingen

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tübingen, Germany
        • University of Tübingen, Department of Psychiatry and Psychotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: 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°
Experimental: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hallucination change score (HCS)
Time Frame: 3 and 6 weeks
3 and 6 weeks
Positive and Negative Symptom Scale (PANSS)
Time Frame: 3 and 6 weeks
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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christian Plewnia, MD, Universtity of Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

November 21, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 13, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Auditory Hallucinations

Clinical Trials on continuous theta burst stimulation (cTBS)

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