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

Sponsor
University of Tehran (Other)
Overall Status
Unknown status
CT.gov ID
NCT01315587
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
72
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment 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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, 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
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Nov 1, 2015
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. Positive and negative syndrome scale ( PANSS ) [Change of baseline in negative symptoms at 20 sessions]

    Secondary Outcome Measures

    1. 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

    2. 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.

    3. 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)

    4. 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.

    Other Outcome Measures

    1. Hamilton Depression Rating Scale (HAMD-17) [3 times (Before treatment,session 10, immediately after treatment)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Atieh Clinical Neuroscience Center (ACNC) Tehran Iran, Islamic Republic of 1969713663

    Sponsors and Collaborators

    • University of Tehran

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    reza kazemi, Researcher, University of Tehran
    ClinicalTrials.gov Identifier:
    NCT01315587
    Other Study ID Numbers:
    • 23456
    First Posted:
    Mar 15, 2011
    Last Update Posted:
    Sep 1, 2015
    Last Verified:
    Aug 1, 2015
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Sep 1, 2015