7 Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on depression severity, response inhibition, cognitive flexibility and visuo-spatial memory in patients with Depressive Disorder
investigating the effect of two types of repetitive transcranial magnetic stimulation protocols in the severity of depression, cognitive flexibility, response inhibition, and visual-spatial memory in patients with depressive disorder.
Design
A) Before presenting the independent variable, 55 patients will be selected in the available method. They will then be initially assessed by the Beck Scoring Index and the Wisconsin, Corsi, and Go-Nogo Cognitive Tasks.
B) In the Independent variable implementation stage, the subject will receive 10 sessions of treatment during 2 weeks. Sham's group will receive only artificial stimuli.
Settings and conduct
This study will be performed at َthe Azarbaijan Shahid Madani University. The subjects will not be explained whether they will be in the stimulus or sham group, and the individuals and their type of stimulus will be defined with a specific code.
Participants/Inclusion and exclusion criteria
Being right-hand
Having physical health
No trauma or seizures in the individual or family
Not having other psychological disorders
No dependence on psychotropic substances
Not being pregnant
No metal, prosthesis, implant, or pacemaker
Intervention groups
The first group with unilateral stimulation of DLPFC in patients with depressive disorder
The second group with bilateral stimulation of DLPFC in patients with depressive disorder
The third group with sham stimulation in patients with depressive disorder
Main outcome variables
Reducing the severity of depression; Improving patients' cognitive functions (improving cognitive flexibility; improving visual-spatial memory; improving response inhibition)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210211050329N1
Registration date:2021-03-02, 1399/12/12
Registration timing:prospective
Last update:2021-03-02, 1399/12/12
Update count:0
Registration date
2021-03-02, 1399/12/12
Registrant information
Name
Fatemeh Asgharian asl
Name of organization / entity
Azarbaijan Shahid Madani University
Country
Iran (Islamic Republic of)
Phone
+98 41 3145 2406
Email address
fatemeh.asgharian@azaruniv.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-05, 1399/12/15
Expected recruitment end date
2021-04-04, 1400/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
7 Effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on depression severity, response inhibition, cognitive flexibility and visuo-spatial memory in patients with Depressive Disorder
Public title
Effect of rTMS on Cognitive Function of Depressive Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being right-hand
Age between 25-45
Having physical health
Exclusion criteria:
Being pregnant
Having metal, prosthesis, implant or pacemaker
Dependence on psychotropic substances
History of Trauma or seizures in the individual or family
Having other psychological disorders
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple
Randomization unit: individual
Randomization tool: In separate sheets, we will write the names of all the participants in the study and will put them in a container, and then randomly will pick the names and will add the first one to the list of the unilateral stimulation group, the second to the list of the bilateral stimulation group, and the third to the control group list. We will continue this until the last person.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will not be explained whether they are in the intervention group or in the control group (blinding takes place), but due to the difference in stimulation areas in the two intervention groups, blinding between intervention groups is not possible for participants.
Due to the difference in stimulation areas in the intervention groups and the difference in the stimulation angle in the control group and the intervention groups, blinding is impossible for the researcher. However, the data analyzer will be blind because he will receive only the list of data specified by a different code. And the person does not know which code is for which group—for example, the number 25 for a unilateral group. The number 35 will be assigned to the control group and the number 15 to the bilateral group, which in data analysis, the analyst will not be aware of the allocation of these numbers to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Abresan. Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.TBZMED.REC.1398.1248
Health conditions studied
1
Description of health condition studied
Depressive Disorder
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
Primary outcomes
1
Description
Depression score in Beck questionnaire and clients' performance in cognitive functions of response inhibition, cognitive flexibility, and visual-spatial memory
Timepoint
Before the intervention and after two weeks
Method of measurement
By Beck Depression questionnaire and Clients' Performance in Cognitive Tasks of Go-Go, Corsi, and Wisconsin
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The unilateral group will receive stimulation of Left DLPFC (20Hz, 5s in each train, 2100 pulses, and 85% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp.
Category
Treatment - Other
2
Description
Intervention group 2: Stimulation will be performed by using a Magstim super-rapid magnetic stimulator (Wales, UK). The bilateral group will receive stimulation of left DLPFC (20Hz, 5s in each train, 1400 pulses, and 85% of Motor Threshold), followed by Right DLPFC stimulation (1Hz, 10s in each train, 700 pulses, and 110% of Motor Threshold) for 10 sessions during 2 weeks( 5 sessions each week). The coil will be placed at a 45-degree angle on the patient's scalp.
Category
Treatment - Other
3
Description
Control group: In the control group, we will perform artificial stimulation and for 10 sessions for 2 weeks( 5 sessions each week), but the coil will be placed at a 90-degree angle on the patient's scalp. So they will not receive any stimulation.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Azarbaijan Shahid Madani University
Full name of responsible person
Ladan Vaghef
Street address
Tabriz, East Azarbaijan Province 35 km. of، Maragheh Hwy
City
Tabriz
Province
East Azarbaijan
Postal code
5375171379
Phone
+98 41 3432 7500
Email
l.vaghef@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Ali Ajami
Street address
Tabriz, East Azarbaijan Province 35 km. of، Maragheh Hwy