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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01315587
• Other study ID #: 23456
• Status: Recruiting
• Phase: Phase 2
• First received: March 14, 2011
• Last updated: August 30, 2015
• Start date: January 2011
• Est. completion date: January 2017

Study information

• Verified date: August 2015
• Source: University of Tehran
• Contact: Reza kazemi, PhD
• Phone: 009802184012128
• Email: rezakazemi[@]ut.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2017
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )
3 pulses at 50Hz repeated each 200 ms for 2 seconds 80% MT 20 days treatment
• repetitive Transcranial Magnetic Stimulation (Magstim rapid2)
LDLPFC 110% MT 15 Hz 20 days
• repetitive Transcranial Magnetic Stimulation(Magstim rapid2)
Placebo treatment: Sham coil

Locations

Country	Name	City	State
Iran, Islamic Republic of	Atieh Clinical Neuroscience Center (ACNC)	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
University of Tehran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hamilton Depression Rating Scale (HAMD-17)		3 times (Before treatment,session 10, immediately after treatment)	No
Primary	Positive and negative syndrome scale ( PANSS )		Change of baseline in negative symptoms at 20 sessions	No
Secondary	Calgary depression for schizophrenia scale (CDSS)	The CDSS is administered for measuring of depression before treatment, session 10, immediately after treatment	3 times (Before treatment, session 10, immediately after treatment)	No
Secondary	Schizophrenia quality of life scale (SQLS)	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)	No
Secondary	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)	3 times (Before treatment, session 10, immediately after treatment)	No
Secondary	QEEG and low resolution brain electromagnetic tomography (LORETA)	QEEG and LORETA is applying for assessment brain waves patterns.	3 times (Before treatment,session 10, immediately after treatment)	No