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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 14 July 2014
Main ID:  ISRCTN61109178
Date of registration: 10/02/2012
Primary sponsor: Swiss National Fund (Switzerland)
Public title: Transcranial Magnetic Stimulation (TMS) treatment study in auditory verbal hallucinations N/A
Scientific title: Transcranial Magnetic Stimulation (TMS) treatment study in auditory verbal hallucinations: a randomised controlled trial
Date of first enrolment: Dec 15 2008
Target sample size: 30-45
Recruitment status: Completed/Not recruiting
URL:  http://isrctn.org/ISRCTN61109178
Study type:  Interventional
Study design:  Randomized controlled trial  
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Inclusion criteria: 1. Diagnosis of schizophrenia or schizoaffective disorder according to ICD-10
2. Medication-resistant auditory verbal hallucinations
3. 18?65-years of age, and right-handed
4. Therapy refractoriness is defined as non response to at least 2 antipsychotic treatments in common dosages, each administered for at least 8 weeks

Exclusion criteria: 1. History of epileptic seizures
2. Signs of elevated neuronal activity by electroencephalography (EEG)
3. Magnetic resonance (MR) contraindications, and
4. Medical disorders other than schizophrenia or schizoaffective disorder


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Schizophrenia or schizoaffective disorder, medication resistant auditory hallucinations
Intervention(s)
1. Theta Burst transcranial magnetic stimulation (TBS group)
2. 1Hz transcranial magnetic stimulation and
3. Control group (treatment as usual)

A custom TMS stimulator (MagPro R 100, Medtronic Functional Diagnostics, Skovlunde, Denmark) is used to generate repetitive biphasic magnetic pulses. Magnetic pulses are delivered with a figure-8-coil (Magnetic Coil Transducer MC-B70, Medtronic). During the experiment, rTMS pulse intensity is adjusted to 90% of the motor threshold. Patients will be randomly assigned to receive a 1 Hz or theta burst (TBS) TMS protocol. In both treatment groups, the target area is stimulated for 10 consecutive days. Stimulation at 1 Hz was applied once a day, 4min on day 1, 8min on day 2 and 16min from day 3-10.

In the TBS group, each burst contains 3 pulses at 30 Hz, repeated with an interburst interval of 100 ms. TBS is applied in double trains with a 15 min intertrain interval. On the first 3 days, 2 double trains of TBS will be applied, whereas on days 3?10, 1 double TBS train was applied. Safety protocols are in accordance with international safety standards of rTMS experimentation.

The control group is receiving treatment as usual.

Magnetic resonance imaging and psychopathological ratings are performed one day before the start and on the last day of the study
Primary Outcome(s)
1. Psychopathology rates:
1.1. Positive and negative symtpom scale
1.2. Psychotic Symptom Rating Scales (PSYRATS)
1.3. Auditory hallucination rating scale
2. Cerebral blood flow as measured by magnetic resonance arterial spin labeling
Secondary Outcome(s)
1. Comparison of conventionally used 10-20 EEG coil placement approach with a frameless steretactic neuronavigation system to functionally defined (fMRI) target area
2. TMS effects on electroencephalography measures
3. Assessment of side effects
Secondary ID(s)
N/A
Source(s) of Monetary Support
Swiss National Fund (Switzerland) (ref 59077)
Secondary Sponsor(s)
N/A
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