- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01478880
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations (TBS-H)
July 13, 2013 updated by: Christian Plewnia, MD, University Hospital Tuebingen
Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tübingen, Germany
- University of Tübingen, Department of Psychiatry and Psychotherapy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: 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°
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Experimental: cTBS
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
Time Frame: 3 weeks
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Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
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3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hallucination change score (HCS)
Time Frame: 3 and 6 weeks
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3 and 6 weeks
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Positive and Negative Symptom Scale (PANSS)
Time Frame: 3 and 6 weeks
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3 and 6 weeks
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PSYRATS subscale for auditory hallucinations
Time Frame: 6 weeks
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Change of PSYRATS AH score compared to baseline after 6 weeks of treatment
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christian Plewnia, MD, Universtity of Tuebingen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
July 1, 2013
Study Registration Dates
First Submitted
November 21, 2011
First Submitted That Met QC Criteria
November 21, 2011
First Posted (Estimate)
November 23, 2011
Study Record Updates
Last Update Posted (Estimate)
July 16, 2013
Last Update Submitted That Met QC Criteria
July 13, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TBS-H 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Auditory Hallucinations
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Mental Health Services in the Capital Region, DenmarkMental Health Services in the Region of Southern Denmark; Mental Health Services...Active, not recruitingAuditory HallucinationsDenmark
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The University of New South WalesNSW Schizophrenia Fellowship; Rebecca Cooper Medical Research FoundationCompletedAuditory HallucinationsAustralia
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Fondation LenvalCompletedAuditory HallucinationsFrance
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Beth Israel Deaconess Medical CenterRecruitingPsychosis | Hallucinations, AuditoryUnited States
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Yale UniversityNational Institute of Mental Health (NIMH)RecruitingPsychosis | Hallucinations, AuditoryUnited States
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RWTH Aachen UniversityCompletedHallucinations, Verbal AuditoryGermany
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University Medical Center GroningenZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingHallucinations, Verbal AuditoryNetherlands
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Dr Cipto Mangunkusumo General HospitalUnknownHallucinations, Verbal AuditoryIndonesia
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University Hospital, LilleNational Research Agency, FranceNot yet recruitingSchizophrenia | Hallucinations, Auditory | Hallucinations, Visual
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Hospital de Clinicas de Porto AlegreCompletedSchizophrenia | Auditory HallucinationsBrazil
Clinical Trials on continuous theta burst stimulation (cTBS)
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Emory UniversityRecruiting
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University of Missouri-ColumbiaNot yet recruiting
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Medical University of South CarolinaCompleted
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Jean-Marie AnnoniCompleted
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West China HospitalCompletedEssential Tremor | Continuous Theta Burst StimulationChina
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University of Missouri-ColumbiaCompletedTobacco Use DisorderUnited States
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Stanford UniversityTerminatedHealthy VolunteersUnited States
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King's College LondonSouth London and Maudsley NHS Foundation TrustRecruiting
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RenJi HospitalNot yet recruitingPostoperative Delirium | Continuous Theta Burst Stimulation