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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by University of Tehran
Information provided by (Responsible Party):
reza kazemi, University of Tehran Identifier:
First received: March 14, 2011
Last updated: August 30, 2015
Last verified: August 2015

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.

Condition Intervention Phase
Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia

Resource links provided by NLM:

Further study details as provided by University of Tehran:

Primary Outcome Measures:
  • Positive and negative syndrome scale ( PANSS ) [ Time Frame: Change of baseline in negative symptoms at 20 sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Calgary depression for schizophrenia scale (CDSS) [ Time Frame: 3 times (Before treatment, session 10, immediately after treatment) ] [ Designated as safety issue: No ]
    The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment

  • Schizophrenia quality of life scale (SQLS) [ Time Frame: 3 times (Before treatment, session 10, immediately after treatment) ] [ Designated as safety issue: No ]
    The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment.

  • Cantab Schizophrenia Battery [ Time Frame: 3 times (Before treatment, session 10, immediately after treatment) ] [ Designated as safety issue: No ]

    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) [ Time Frame: 3 times (Before treatment,session 10, immediately after treatment) ] [ Designated as safety issue: No ]
    QEEG and LORETA is applying for assessment brain waves patterns.

Other Outcome Measures:
  • Hamilton Depression Rating Scale (HAMD-17) [ Time Frame: 3 times (Before treatment,session 10, immediately after treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intermittent theta burst stimulation Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
  • 3 pulses at 50Hz repeated each 200 ms for 2 seconds
  • 80% MT
  • 20 days treatment
Other Names:
  • TMS
  • rTMS
  • TBS
  • iTBS
Active Comparator: repetitive Transcranial Magnetic Stimulation Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
LDLPFC 110% MT 15 Hz 20 days
Other Names:
  • TMS
  • rTMS
Placebo Comparator: Sham TMS Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Placebo treatment: Sham coil


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01315587

Contact: Reza kazemi, PhD 009802184012128

Iran, Islamic Republic of
Atieh Clinical Neuroscience Center (ACNC) Recruiting
Tehran, Iran, Islamic Republic of, 1969713663
Contact: Reza Rostami, MD    009802184012101   
Principal Investigator: Reza Rostami, MD         
Sub-Investigator: Reza Kazemi, PhD         
Sub-Investigator: Sanaz Khomami, PhD         
Sponsors and Collaborators
University of Tehran
  More Information

No publications provided

Responsible Party: reza kazemi, Researcher, University of Tehran Identifier: NCT01315587     History of Changes
Other Study ID Numbers: 23456
Study First Received: March 14, 2011
Last Updated: August 30, 2015
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on October 07, 2015