The Comparison of effectiveness of repetitive TMS and iTBS on negative Symptoms and Cognition in Patients with Schizophrenia:a study randomized and double blind
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 (10th session), and after the treatment (post test).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903254191N1
Registration date:2011-01-09, 1389/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-09, 1389/10/19
Registrant information
Name
Reza Kazemi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8401 2128
Email address
rezakazemi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Atieh comprehensive psyche and nerve center
Expected recruitment start date
2011-01-05, 1389/10/15
Expected recruitment end date
2011-07-21, 1390/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of effectiveness of repetitive TMS and iTBS on negative Symptoms and Cognition in Patients with Schizophrenia:a study randomized and double blind
Public title
Repetitive transcranial magnetic stimulation and intermittent theta burst stimulation in schizophrenia
Purpose
Treatment
Inclusion/Exclusion 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, Intracranial Implant and other ferromagnetic materials close to the head, Cardiac Pacemaker, drug Pumps, acute heart attack, the risk of Seizure with any reasons, high Intracranial pressure, The history of epilepsy or Seizure in the first relatives, any metal in Head, brain trauma, history of loss of consciousness for more than 5 minutes, pregnancy, breastfeeding, drug dependency, high risk of Suicide, significant positive symptoms
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social wellfare and rehabilitation sciences
Street address
University of Social Wellfare and Rehabilitation Sciences, Kodakyar St, Evin, Tehran, Iran.
City
Tehran
Postal code
1985713834
Approval date
2010-11-07, 1389/08/16
Ethics committee reference number
801/4/89/1786
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
negative symptoms
Timepoint
Session One,Session ten, Session twenty
Method of measurement
Positive and negative symptom scale
2
Description
Cognitive functioning
Timepoint
Sessions One, ten, and twenty
Method of measurement
Neuropsychology Battery Tests
Secondary outcomes
1
Description
Depression
Timepoint
Session One,Session ten, Session twenty
Method of measurement
Calgary depression for schizophrenia scale (CDSS)
2
Description
Quality of life
Timepoint
Session One,Session ten, Session twenty
Method of measurement
Schizophrenia quality of life scale (SQLS)
3
Description
Social Functioning
Timepoint
Sessions One, ten, and twenty
Method of measurement
Social and occupational functioning Assessment scale (SOFAS)
Intervention groups
1
Description
15 Hz rTMS are applied during 20 to 30 minutes in 20 sessions
Category
Treatment - Devices
2
Description
50Hz theta burst ia applied during 5 to 10 minutes in 20 sessions
Category
Treatment - Devices
3
Description
Sham coil in 20 sessions
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
razi psychiatric hospital
Full name of responsible person
Dr.mohammad reza khodaei
Street address
Razi Psychiatric Hospital, University of Social Welfare and Rehabilitation Sciences, Amin Abad, Shahre Rey, Tehran, Iran
City
tehran
2
Recruitment center
Name of recruitment center
Atieh comprehensive psyche and nerve center
Full name of responsible person
Dr. Reza Rostami
Street address
23 No., Vali nezhad St., Vali asr Ave., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Atieh comprehensive psyche and nerve center
Full name of responsible person
Dr.reza rostami
Street address
23 No., Vali nezhad St., Vali asr Ave., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Atieh comprehensive psyche and nerve center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Kazemi
Position
Master of science in clinical psychology
Other areas of specialty/work
Street address
Faculty of Psychology & Education University of Tehran Jalal Al-e-Ahmad Ave. Tehran, Iran,P.O. Box 11455/6456
City
tehran
Postal code
Phone
+98 21 8401 2128
Fax
Email
rezakazemi@ut.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Reza Kazemi
Position
Master of Science in clinical psychology
Other areas of specialty/work
Street address
Faculty of Psychology & Education University of Tehran Jalal Al-e-Ahmad Ave. Tehran, Iran,P.O. Box 11455/6456
City
Tehran
Postal code
Phone
+98 21 8401 2128
Fax
Email
rezakazemi@ut.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)