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

August 30, 2015 updated by: reza kazemi, University of Tehran

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1969713663
        • Recruiting
        • Atieh Clinical Neuroscience Center (ACNC)
        • Contact:
        • Principal Investigator:
          • Reza Rostami, MD
        • Sub-Investigator:
          • Reza Kazemi, PhD
        • Sub-Investigator:
          • Sanaz Khomami, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Positive and negative syndrome scale ( PANSS )
Time Frame: Change of baseline in negative symptoms at 20 sessions
Change of baseline in negative symptoms at 20 sessions

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale (HAMD-17)
Time Frame: 3 times (Before treatment,session 10, immediately after treatment)
3 times (Before treatment,session 10, immediately after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tehran

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

November 1, 2015

Study Completion (ANTICIPATED)

January 1, 2017

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (ESTIMATE)

March 15, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 30, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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