Auditory HallucinationsPhase 2TBS-HNCT01478880
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations
A Phase 2 study testing continuous theta burst stimulation (cTBS) in people with Auditory Hallucinations, run by University Hospital Tuebingen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Auditory Hallucinations
- What is being tested?
- continuous theta burst stimulation (cTBS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- epilepsy
- benzodiazepines > 1,5mg lorazepam / d
- pregnancy
- metal parts in the brain
- cardiac pacemaker
- deep brain stimulation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Tübingen, Department of Psychiatry and Psychotherapy
Tübingen
About this study
Official title: 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.
- Conditions
- Auditory Hallucinations
- Being tested
- continuous theta burst stimulation (cTBS), sham cTBS
- Medical subject headings
- Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous theta burst stimulation (cTBS)Procedure or surgery
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 cTBSProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| cTBS | Experimental | Not described Receives: Procedure: continuous theta burst stimulation (cTBS) |
| Sham cTBS | Sham comparator | Not described Receives: Procedure: sham cTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
Measured: 3 weeks
Secondary outcomes (3)
Hallucination change score (HCS)
Measured: 3 and 6 weeks
Positive and Negative Symptom Scale (PANSS)
Measured: 3 and 6 weeks
PSYRATS subscale for auditory hallucinations
Change of PSYRATS AH score compared to baseline after 6 weeks of treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auditory HallucinationsStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Plewnia, MD, University Hospital Tuebingen
- Investigators
- Christian Plewnia, MD, Principal investigator, Universtity of Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478880
- Sponsor's protocol ID
- TBS-H 1
- Acronym
- TBS-H
- Status last verified
- Jul 2013
- First submitted
- 21 Nov 2011
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bilateral Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation) for the Treatment of Auditory Hallucinations
- ClinicalTrials.gov ID
- NCT01478880
- Acronym / sponsor ID
- TBS-H / TBS-H 1
- Conditions
- Auditory Hallucinations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTBS | Experimental | Procedure: continuous theta burst stimulation (cTBS) |
| Sham cTBS | Sham comparator | Procedure: sham cTBS |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- epilepsy
- benzodiazepines > 1,5mg lorazepam / d
- pregnancy
- metal parts in the brain
- cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | cTBS |
| sham cTBSbilateral 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° | Procedure or surgery | Sham cTBS |
Primary outcome
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations
Time frame: 3 weeks
Change of PSYRATS AH score compared to baseline after 3 weeks of treatment
3 secondary outcomes
Hallucination change score (HCS)
Time frame: 3 and 6 weeks
Positive and Negative Symptom Scale (PANSS)
Time frame: 3 and 6 weeks
PSYRATS subscale for auditory hallucinations
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
Related trials for Auditory Hallucinations
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
Not yet recruiting
DecNef for Auditory Verbal Hallucinations (AVH) in Schizophrenia
Schizophrenia Disorder, Schizoaffecitve Disorder
Recruiting
Neuronavigated rTMS for Treatment-Resistant Auditory Hallucinations
Schizophrenia, Auditory Verbal Hallucinations
Recruiting
fMRI-based Neurofeedback to Relieve Drug-resistant Auditory Hallucinations
Schizophrenia, Hallucinations, Auditory
Recruiting
Reduction of Auditory-Verbal Hallucinations in Schizophrenia Through Cortical Neuromodulation
Treatment Resistant Schizophrenia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Plewnia, MD principal investigator
Universtity of Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing continuous theta burst stimulation (cTBS) in people with Auditory Hallucinations, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychotic Symptom Rating Scales (PSYRATS), subscale for auditory hallucinations (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.