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

Primary Purpose

Auditory Hallucinations

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
continuous theta burst stimulation (cTBS)
sham cTBS
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Auditory Hallucinations

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Tübingen, Department of Psychiatry and Psychotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

cTBS

Sham cTBS

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2011
Last Updated
July 13, 2013
Sponsor
University Hospital Tuebingen
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1. Study Identification

Unique Protocol Identification Number
NCT01478880
Brief Title
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations
Acronym
TBS-H
Official Title
Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Auditory Hallucinations

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cTBS
Arm Type
Experimental
Arm Title
Sham cTBS
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
continuous theta burst stimulation (cTBS)
Intervention Description
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
Intervention Name(s)
sham cTBS
Intervention Description
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 Outcome Measure Information:
Title
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
Description
Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Hallucination change score (HCS)
Time Frame
3 and 6 weeks
Title
Positive and Negative Symptom Scale (PANSS)
Time Frame
3 and 6 weeks
Title
PSYRATS subscale for auditory hallucinations
Description
Change of PSYRATS AH score compared to baseline after 6 weeks of treatment
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Plewnia, MD
Organizational Affiliation
Universtity of Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tübingen, Department of Psychiatry and Psychotherapy
City
Tübingen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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