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

Phase 2

• Conditions: Schizophrenia
• Interventions: Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2); Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 ); Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)

• Registration Number: NCT01315587
• Lead Sponsor: University of Tehran

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-30
• Last Update Posted: 2015-09-01
• Primary Completion: 2015-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TMS	repetitive Transcranial Magnetic Stimulation(Magstim rapid2)	-
intermittent theta burst stimulation	repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )	-
repetitive Transcranial Magnetic Stimulation	repetitive Transcranial Magnetic Stimulation (Magstim rapid2)	-

Primary Outcome Measures

Name	Time	Method
Positive and negative syndrome scale ( PANSS )	Change of baseline in negative symptoms at 20 sessions

Secondary Outcome Measures

Name	Time	Method
Calgary depression for schizophrenia scale (CDSS)	3 times (Before treatment, session 10, immediately after treatment)	The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment
Schizophrenia quality of life scale (SQLS)	3 times (Before treatment, session 10, immediately after treatment)	The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment.
Cantab Schizophrenia Battery	3 times (Before treatment, session 10, immediately after treatment)	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)
QEEG and low resolution brain electromagnetic tomography (LORETA)	3 times (Before treatment,session 10, immediately after treatment)	QEEG and LORETA is applying for assessment brain waves patterns.

Trial Locations

Locations (1)

Atieh Clinical Neuroscience Center (ACNC); 🇮🇷 Tehran, Iran, Islamic Republic of