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

March 14, 2011
August 27, 2013
January 2011
November 2015   (final data collection date for primary outcome measure)
Positive and negative syndrome scale ( PANSS ) [ Time Frame: Change of baseline in negative symptoms at 20 sessions ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01315587 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia
A Double-blind Placebo Controlled Trial the Comparison of Effectiveness of Repetitive TMS and iTBS on Negative Symptoms and Cognition in Patients With Schizophrenia

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
    LDLPFC 110% MT 15 Hz 20 days
    Other Names:
    • TMS
    • rTMS
  • Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
    Placebo treatment: Sham coil
  • Active Comparator: intermittent theta burst stimulation
    Intervention: Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
  • Active Comparator: repetitive Transcranial Magnetic Stimulation
    Intervention: Device: repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
  • Placebo Comparator: Sham TMS
    Intervention: Device: repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
January 2017
November 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact: Reza kazemi, MA 009802184012128 rezakazemi@ut.ac.ir
Iran, Islamic Republic of
 
NCT01315587
23456
Yes
reza kazemi, University of Tehran
University of Tehran
Not Provided
Not Provided
University of Tehran
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP