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

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Sponsored by
University of Tehran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atieh Clinical Neuroscience Center (ACNC)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

intermittent theta burst stimulation

repetitive Transcranial Magnetic Stimulation

Sham TMS

Arm Description

Outcomes

Primary Outcome Measures

Positive and negative syndrome scale ( PANSS )

Secondary Outcome Measures

Calgary depression for schizophrenia scale (CDSS)
The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment
Schizophrenia quality of life scale (SQLS)
The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment.
Cantab Schizophrenia Battery
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)
QEEG and LORETA is applying for assessment brain waves patterns.

Full Information

First Posted
March 14, 2011
Last Updated
August 30, 2015
Sponsor
University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT01315587
Brief Title
Repetitive Transcranial Magnetic Stimulation and Intermittent Theta Burst (iTBS) in Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tehran

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intermittent theta burst stimulation
Arm Type
Active Comparator
Arm Title
repetitive Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Title
Sham TMS
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
Other Intervention Name(s)
TMS, rTMS, TBS, iTBS
Intervention Description
3 pulses at 50Hz repeated each 200 ms for 2 seconds 80% MT 20 days treatment
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
Other Intervention Name(s)
TMS, rTMS
Intervention Description
LDLPFC 110% MT 15 Hz 20 days
Intervention Type
Device
Intervention Name(s)
repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Intervention Description
Placebo treatment: Sham coil
Primary Outcome Measure Information:
Title
Positive and negative syndrome scale ( PANSS )
Time Frame
Change of baseline in negative symptoms at 20 sessions
Secondary Outcome Measure Information:
Title
Calgary depression for schizophrenia scale (CDSS)
Description
The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment
Time Frame
3 times (Before treatment, session 10, immediately after treatment)
Title
Schizophrenia quality of life scale (SQLS)
Description
The SQLS is administered for apprising of quality of life before treatment, session 10, immediately after treatment.
Time Frame
3 times (Before treatment, session 10, immediately after treatment)
Title
Cantab Schizophrenia Battery
Description
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)
Time Frame
3 times (Before treatment, session 10, immediately after treatment)
Title
QEEG and low resolution brain electromagnetic tomography (LORETA)
Description
QEEG and LORETA is applying for assessment brain waves patterns.
Time Frame
3 times (Before treatment,session 10, immediately after treatment)
Other Pre-specified Outcome Measures:
Title
Hamilton Depression Rating Scale (HAMD-17)
Time Frame
3 times (Before treatment,session 10, immediately after treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients male and female with the range of 18-50 years of age The diagnosis of schizophrenia according to DSM-IV-TR Completion of consent form Being under supervision of a psychiatrist, Being able to adhere to treatment schedule, 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: The history of rTMS treatment for any reason Cardiac pacemaker Drug pumps Acute heart attack The risk of seizure with any reasons The history of epilepsy or seizure in the first relatives Any metal in head Brain trauma Pregnancy Breastfeeding Drug dependency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reza kazemi, PhD
Phone
009802184012128
Email
rezakazemi@ut.ac.ir
Facility Information:
Facility Name
Atieh Clinical Neuroscience Center (ACNC)
City
Tehran
ZIP/Postal Code
1969713663
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reza Rostami, MD
Phone
009802184012101
Email
rrostami@ut.ac.ir
First Name & Middle Initial & Last Name & Degree
Reza Rostami, MD
First Name & Middle Initial & Last Name & Degree
Reza Kazemi, PhD
First Name & Middle Initial & Last Name & Degree
Sanaz Khomami, PhD

12. IPD Sharing Statement

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

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