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

NCT ID: NCT01478880

Last Updated: 2013-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-07-31

Brief 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.

Conditions

Auditory Hallucinations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

cTBS

Group Type: EXPERIMENTAL

continuous theta burst stimulation (cTBS)

Intervention Type: 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

Group Type: SHAM_COMPARATOR

sham cTBS

Intervention Type: 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°

Interventions

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)

Intervention Type: 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°

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Christian Plewnia, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Plewnia, MD

Role: PRINCIPAL_INVESTIGATOR

Universtity of Tuebingen

Locations

University of Tübingen, Department of Psychiatry and Psychotherapy

Tübingen, , Germany

Countries

Germany

Other Identifiers

TBS-H 1

Identifier Type: -

Identifier Source: org_study_id