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

University of Tehran

Status and phase: Unknown; Phase 2

Conditions: Schizophrenia

Treatments: Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2); Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ); Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)

Study type: Interventional

Funder types: Other

Identifiers

NCT01315587

23456

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Outpatients male and female with the range of 18-50 years of age
2. The diagnosis of schizophrenia according to DSM-IV-TR
3. Completion of consent form
4. Being under supervision of a psychiatrist,
5. Being able to adhere to treatment schedule,
6. 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

1. The history of rTMS treatment for any reason
2. Cardiac pacemaker
3. Drug pumps
4. Acute heart attack
5. The risk of seizure with any reasons
6. The history of epilepsy or seizure in the first relatives
7. Any metal in head
8. Brain trauma
9. Pregnancy
10. Breastfeeding
11. Drug dependency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups, including a placebo group

intermittent theta burst stimulation

Active Comparator group

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )

repetitive Transcranial Magnetic Stimulation

Active Comparator group

Treatment:

Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)

Sham TMS

Placebo Comparator group

Treatment:

Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)