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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Tehran
Sponsor:
Information provided by (Responsible Party):
reza kazemi, University of Tehran
ClinicalTrials.gov Identifier:
NCT01315587
First received: March 14, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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
Schizophrenia
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.

  • Social and occupational functioning Assessment scale (SOFAS) [ Time Frame: 3 times(Before treatment, session 10, immediately after treatment) ] [ Designated as safety issue: No ]
    The SOFAS is measured for social functioning and is administered before treatment, session 10, immediately after treatment.

  • Neuropsychology battery test [ Time Frame: 3 times (Before treatment, session 10, immediately after treatment) ] [ Designated as safety issue: No ]

    Neuropsychology battery test is included eight tests, which is measuring for cognitive function. The cognitive function includes working memory, executive function, cognitive flexibility, attention, verbal learning. These scales:

    1. Digit Span in WAIS (Wechsler Adult Intelligence Scale)
    2. Rey Auditory Verbal-learning Test
    3. Stroop
    4. Iowa Gambling Task
    5. Trail Making Test A/B
    6. Verbal (word) Fluency Test
    7. WCST (Wisconsin Card Sorting Test)
    8. Wechsler Memory Scale(R-III)

  • QEEG and low resolution brain electromagnetic tomography (LORETA) [ Time Frame: 2 times (Before treatment, immediately after treatment) ] [ Designated as safety issue: No ]
    QEEG and LORETA is applying for assessment brain waves patterns.


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

  Eligibility

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

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. Intracranial implant and other ferromagnetic materials close to the head
  3. Cardiac pacemaker
  4. Drug pumps
  5. Acute heart attack
  6. The risk of seizure with any reasons
  7. High intracranial pressure
  8. The history of epilepsy or seizure in the first relatives
  9. Any metal in head
  10. Brain trauma
  11. History of loss of consciousness for more than 5 minutes
  12. Pregnancy
  13. Breastfeeding
  14. Drug dependency
  15. High risk of suicide
  16. Significant positive symptoms
  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 ClinicalTrials.gov identifier: NCT01315587

Contacts
Contact: Reza kazemi, MA 009802184012128 rezakazemi@ut.ac.ir

Locations
Iran, Islamic Republic of
Atieh comprehensive psyche and nerve center Recruiting
Tehran, Iran, Islamic Republic of, 1969713663
Contact: Reza Rostami, MD    009802184012101    rrostami@ut.ac.ir   
Principal Investigator: Reza kazemi, MA         
Sub-Investigator: sanaz khomami, MA         
Sponsors and Collaborators
University of Tehran
  More Information

No publications provided

Responsible Party: reza kazemi, Researcher, University of Tehran
ClinicalTrials.gov Identifier: NCT01315587     History of Changes
Other Study ID Numbers: 23456
Study First Received: March 14, 2011
Last Updated: August 27, 2013
Health Authority: Iran: Ethics Committee

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014