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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01478880

Acronym

TBS-H

Enrollment

Registered

2011-11-23

Start date

2011-05-31

Completion date

2013-07-31

Last updated

2013-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Auditory Hallucinations

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.

Interventions

PROCEDUREcontinuous 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)

PROCEDUREsham 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°

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations	3 weeks	Change of PSYRATS AH score compared to baseline after 3 weeks of treatment

Secondary

Measure	Time frame	Description
Hallucination change score (HCS)	3 and 6 weeks	—
Positive and Negative Symptom Scale (PANSS)	3 and 6 weeks	—
PSYRATS subscale for auditory hallucinations	6 weeks	Change of PSYRATS AH score compared to baseline after 6 weeks of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026