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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT01478880

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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°

Arm

Intervention/Treatment

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°

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christian Plewnia, MD, Principal Investigator, University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT01478880

Other Study ID Numbers:

TBS-H 1

First Posted:

Nov 23, 2011

Last Update Posted:

Jul 16, 2013

Last Verified:

Jul 1, 2013

Additional relevant MeSH terms:

Hallucinations

Study Results

No Results Posted as of Jul 16, 2013