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NCT Number: NCT01478880

Efficacy and Safety of Bilateral 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.

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Key information

Conditions

Auditory Hallucinations Hallucinations Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

continuous theta burst stimulation (cTBS)

Procedure

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

Procedure

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°

Primary outcomes

  1. 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 outcomes

  1. Hallucination change score (HCS)

    Time frame: 3 and 6 weeks

  2. Positive and Negative Symptom Scale (PANSS)

    Time frame: 3 and 6 weeks

  3. PSYRATS subscale for auditory hallucinations

    Time frame: 6 weeks

    Change of PSYRATS AH score compared to baseline after 6 weeks of treatment

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

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

Acronym: TBS-H

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 23, 2011
Registry last updated
Jul 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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