Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia

Study Overview
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Brief Summary
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The pilot studies have showed that theta burst stimulation (TBS) can have the more rapid and durable effects to the apply traditional rTMS protocols. The aim of this study is to investigate the effect of repetitive TMS and theta burst in reduction of negative symptoms and remission of cognitive functioning in patients with schizophrenia. In a randomized, double blind clinical trials, 30 patients with schizophrenia in Razi psychiatric hospital will be assigned to receive repetitive TMS; theta burst, or sham TMS, daily; for 20 sessions. The negative symptoms and cognitive functioning will be assessed before the treatment (pre test) during the treatment (session 10), and after the treatment (post test).QEEG and LORETA apply before and after rTMS in all subjects.

Official Title
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A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
* Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
* Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients male and female with the range of 18-50 years of age The diagnosis of schizophrenia according to DSM-IV-TR Completion of consent form Being under supervision of a psychiatrist, Being able to adhere to treatment schedule, Having stable symptoms as defined by not requiring a change in antipsychotic medication for at least 4 weeks or at least 2 weeks for psychotropic agents prior to entering the Study Exclusion Criteria: The history of rTMS treatment for any reason Cardiac pacemaker Drug pumps Acute heart attack The risk of seizure with any reasons The history of epilepsy or seizure in the first relatives Any metal in head Brain trauma Pregnancy Breastfeeding Drug dependency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intermittent theta burst stimulation<br> | Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )<br>* 3 pulses at 50Hz repeated each 200 ms for 2 seconds 80% MT 20 days treatment<br>* Other names: iTBS;|
| Active Comparator: repetitive Transcranial Magnetic Stimulation<br> | Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)<br>* LDLPFC 110% MT 15 Hz 20 days<br>* Other names: rTMS;|
| Placebo Comparator: Sham TMS<br> | Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)<br>* Placebo treatment: Sham coil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative syndrome scale ( PANSS ) |  | Change of baseline in negative symptoms at 20 sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calgary depression for schizophrenia scale (CDSS) | The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment | 3 times (Before treatment, session 10, immediately after treatment) | 
| Schizophrenia quality of life scale (SQLS) | The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment. | 3 times (Before treatment, session 10, immediately after treatment) | 
| Cantab Schizophrenia Battery | Cantab Schizophrenia Battery is included six tests, which is measuring for cognitive function. The cognitive function includes reaction time, executive function, Sustained attention, , Episodic memory . These scales: Reaction time (RTI) Rapid Visual information processing (RVP) Spatial Working Memory (SWM) One Touch Stockings of Cambridge (OTS) Paired Associates Learning (PAL) Intra-Extra Dimensional set- Shift (IED) | 3 times (Before treatment, session 10, immediately after treatment) | 
| QEEG and low resolution brain electromagnetic tomography (LORETA) | QEEG and LORETA is applying for assessment brain waves patterns. | 3 times (Before treatment,session 10, immediately after treatment) |