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

NCT ID: NCT01315587

Last Updated: 2015-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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intermittent theta burst stimulation

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )

Intervention Type DEVICE

* 3 pulses at 50Hz repeated each 200 ms for 2 seconds
* 80% MT
* 20 days treatment

repetitive Transcranial Magnetic Stimulation

Group Type ACTIVE_COMPARATOR

repetitive Transcranial Magnetic Stimulation (Magstim rapid2)

Intervention Type DEVICE

LDLPFC 110% MT 15 Hz 20 days

Sham TMS

Group Type PLACEBO_COMPARATOR

repetitive Transcranial Magnetic Stimulation(Magstim rapid2)

Intervention Type DEVICE

Placebo treatment: Sham coil

Interventions

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repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )

* 3 pulses at 50Hz repeated each 200 ms for 2 seconds
* 80% MT
* 20 days treatment

Intervention Type DEVICE

repetitive Transcranial Magnetic Stimulation (Magstim rapid2)

LDLPFC 110% MT 15 Hz 20 days

Intervention Type DEVICE

repetitive Transcranial Magnetic Stimulation(Magstim rapid2)

Placebo treatment: Sham coil

Intervention Type DEVICE

Other Intervention Names

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TMS rTMS TBS iTBS TMS rTMS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tehran

OTHER

Sponsor Role lead

Responsible Party

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reza kazemi

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Atieh Clinical Neuroscience Center (ACNC)

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Reza kazemi, PhD

Role: CONTACT

009802184012128

Facility Contacts

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Reza Rostami, MD

Role: primary

009802184012101

Other Identifiers

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23456

Identifier Type: -

Identifier Source: org_study_id

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