Evaluation of the therapeutic effect of repetitive Transcranial Magnetic Stimulation (rTMS) on the negative symptoms of schizophrenia
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Schizophrenic patients referred to Shahid Beheshti Hospital, Zanjan in rTMS ward received active or sham stimulation. The patient and the therapist do not know the type of stimulation. Only rTMS operator is aware of the type of stimulation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with schizophrenia with negative symptoms, Be treated with antipsychotics, The patient is in the maintenance phase.
Criteria for not entering: The patient is pregnant, has depression, has a history of seizures.
Intervention groups
Schizophrenic patients with negative symptoms are divided into two groups of 33 people. The intervention group receives real stimulation. The control group receives sham stimulation.
Main outcome variables
Negative symptoms of schizophrenic patients like poverty of speech, apathy, social withdrawal
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211029052909N1
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Elham Jandaghi Meybodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3346 1574
Email address
el.jandaghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2023-04-04, 1402/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of repetitive transcranial magnetic stimulation on negative symptoms in schizophrenic patients
Public title
Evaluation of the therapeutic effect of rTMS on negative symptoms in schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with schizophrenia with negative symptoms
Be treated with antipsychotics
The patient is in the maintenance phase
Exclusion criteria:
Depression
Seizure
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. 66 patients will be selected to participate in the study by being available and passing the admission conditions. But assigning them to each treatment group will be simple randomization. For randomization with the help of Excel software by generating binomial distribution and 50% probability for n = 66 we produce codes 0 and 1. In this way, 33 codes 0 and 33 codes 1 are generated equally. Each participant gets a 0 or 1 code completely randomly and with a 50% probability. Code 0 is considered as the control group and code 1 is considered as the intervention group. In this way, the type of treatment for each person before entering the study and observation is determined by each member of the research team.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double blind. This means that the researcher and the patient do not know the type of treatment. Due to the fact that the treatment can be performed on the patient by the rTMS operator, the double blind condition can be applied accurately. It is noteworthy that due to the double blind of the study, only the rTMS operator and the statistician know how to codify and assign patients. Patients have already read and signed the informed consent form. All patients are connected to the rTMS device and the cap of the device is placed on their head. No patient is aware of the type of stimulation (active or sham). The rTMS operator knows the type of stimulation. For patients receiving active stimulation, the device is set to 10 Hz. For patients receiving sham stimulation, the device is set to 0 Hz.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Darvazeh Arg
City
Zanjan
Province
Zanjan
Postal code
4513615788
Approval date
2021-09-21, 1400/06/30
Ethics committee reference number
IR.ZUMS.REC.1400.265
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 in schizophrenic patients like poverty of speech, apathy, social withdrawal
Timepoint
One day before starting treatment، One day after the end of treatment, Three weeks after the end of treatment
Method of measurement
The Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
1
Description
Score obtained from Positive and Negative Syndrome Scale
Timepoint
One day before starting treatment،, One day after the end of treatment, Three weeks after the end of treatment
Method of measurement
PANSS
Intervention groups
1
Description
Intervention group: Patients were treated with active rTMS. 15 active rTMS sessions with a frequency of 10 Hz, 3 times a week for 5 consecutive weeks. The cap of the device is placed on the patient's head and they receive stimulation in the lateral dorsolateral prefrontal cortex.
Category
Treatment - Other
2
Description
Control group: Patients were treate with sham. Patients connect to the rTMS device and the cap of the device is placed on the patients' heads, but they receive sham stimulation. 15 sham rTMS session with a frequency of 0 Hz, 3 times a week for 5 consecutive weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Zanjan
Full name of responsible person
Parisa Entezari
Street address
Besat street
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
beheshti@zums.ac.ir
Web page address
http://beheshti.zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Vice chancellor for research,Zanjan University of Medical Sciences.Dr.Alereza Shoghli
Street address
Besat street
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Fax
+98 24 3354 2403
Email
beheshti@zums.ac.ir
Web page address
http://beheshti.zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham Faghihzadeh
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Mahdavi blv
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 912 608 0676
Email
e.faghihzadeh@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Ahmad Zolghadriha
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Darvazeh Arg
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
ahmad_zolghadriha@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elham Jandaghi Meybodi
Position
assistant
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Darvazeh Arg
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 4001
Email
el.jandaghi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data can be published after the individuals are not identified
When the data will become available and for how long
When publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For scientific research
From where data/document is obtainable
Library of Zanjan University of Medical Sciences
What processes are involved for a request to access data/document