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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01478880
First Posted: November 23, 2011
Last Update Posted: July 16, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christian Plewnia, MD, University Hospital Tuebingen
  Purpose
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.

Condition Intervention Phase
Auditory Hallucinations Procedure: continuous theta burst stimulation (cTBS) Procedure: sham cTBS Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations

Further study details as provided by Christian Plewnia, MD, University Hospital Tuebingen:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 16
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cTBS 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 Comparator: Sham cTBS Procedure: 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°

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478880


Locations
Germany
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen, Germany
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Christian Plewnia, MD Universtity of Tuebingen
  More Information

Responsible Party: Christian Plewnia, MD, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01478880     History of Changes
Other Study ID Numbers: TBS-H 1
First Submitted: November 21, 2011
First Posted: November 23, 2011
Last Update Posted: July 16, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Hallucinations
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms