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

This study is currently recruiting participants.
Verified July 2012 by University Hospital Tuebingen
Sponsor:
Information provided by (Responsible Party):
Christian Plewnia, MD, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01478880
First received: November 21, 2011
Last updated: July 25, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 University Hospital Tuebingen:

Primary Outcome Measures:
  • Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Positive and Negative Symptom Scale (PANSS) [ Time Frame: 3 and 6 weeks ] [ Designated as safety issue: No ]
  • PSYRATS subscale for auditory hallucinations [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change of PSYRATS AH score compared to baseline after 6 weeks of treatment


Estimated Enrollment: 16
Study Start Date: May 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478880

Locations
Germany
University of Tübingen, Department of Psychiatry and Psychotherapy Recruiting
Tübingen, Germany
Contact: Barbara Wasserka     ++49 (0) 7071 29 ext 83664     barbara.wasserka@med.uni-tuebingen.de    
Principal Investigator: Christian Plewnia, MD            
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Christian Plewnia, MD Universtity of Tuebingen
  More Information

No publications provided

Responsible Party: Christian Plewnia, MD, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01478880     History of Changes
Other Study ID Numbers: TBS-H 1
Study First Received: November 21, 2011
Last Updated: July 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 23, 2013