Protocol summary

Summary
Cognitive performance plays a critical role in everyday life of which working memory(WM) is defined as an essential part. Moreover, a number of psychiatric disorders are associated with WM impairment so that deficit in WM and response inhibition are the main elements in many developmental pathology. This study is a randomized sham-controlled trial in order to investigate the effect of repetitive transcranial magnetic stimulation(rTMS) on WM. Inclusion criteria consist of being right handed, not having psychiatric history and aged between 20 to 50 years. 20 subjects are chosen by convenience sampling and allocate to two groups equally. Then 10 Hz active and sham rTMS apply to experimental and control group, sequently, for 10 minutes, 1 section. "Reaction time" and "correct responses" as outcome variables, are recorded while completing a WM task, n-back, before and after stimulation. The data will be analyzed in order to compare the outcome between two groups. In addition, the mediative effect of task difficulty on stimulation efficacy will be evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041733488N1
Registration date: 2017-08-07, 1396/05/16
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-07, 1396/05/16
Registrant information
Name
Fahime Sadat Hosseini Baharanchi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8869 2738
Email address
f.baharan@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Tehran
Expected recruitment start date
2017-08-08, 1396/05/17
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of repetitive transcranial magnetic stimulation on cognitive improvement in healthy adult regarding to task difficulty
Public title
The effect of repetitive transcranial magnetic stimulation on cognitive improvement
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: age 20 to 50;right handed;not getting rTMS treatment before;not having psychiatric history;having the ability to understand and attend the experiment. exclusion criteria: losing the ability to understand and attend to the experiment.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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
ethics committee of University of Tehran
Street address
university of Tehran research department, university ofTehran, 16th Azar St., Tehran, Iran.
City
Tehran
Postal code
1417614411
Approval date
2017-06-24, 1396/04/03
Ethics committee reference number
ir.ut.rec.1395010

Health conditions studied

1

Description of health condition studied
healthy adult
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
reaction time
Timepoint
pre intervention - post intervention
Method of measurement
the distance between stimulus presentation and clicking by subject

2

Description
correct response
Timepoint
pre intervention - post intervention
Method of measurement
the number of correct clicking by subject

Secondary outcomes

empty

Intervention groups

1

Description
Active group - receiving rTMS - on left dorsalateral prefrontal cortex - intensity of 10 Hz - for 12 min - 1 section
Category
Treatment - Other

2

Description
Sham group - receiving sham rTMS - on left dorsalateral prefrontal cortex with deviated coil- intensity of 10 Hz - for 12 min - 1 section
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic of Atie Derakhshan Zehn
Full name of responsible person
Street address
Clinic of Atie Derakhshan Zehn, No.23, Valinejad St., Vanak Square, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Tehran
Full name of responsible person
Dr. Hadi Bahrami Ehsan
Street address
Faculty of Psychology and Educational Sciences, Kardan St., Jalal Ale-Ahmad St., Shahid Chamran highway , 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
University of Tehran
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
Name of organization / entity
University of Tehran
Full name of responsible person
Fahime Sadat Hosseini Baharanchi
Position
Student
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, Kardan St., Jalal Ale-Ahmad St., Shahid Chamran highway , Tehran, Iran.
City
Tehran
Postal code
Phone
+98 912 725 3675
Fax
Email
f.baharan@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fahime Sadat Hosseini Baharanchi
Position
student in master degree
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, Kardan St., Jalal Ale-Ahmad St., Shahid Chamran highway , Tehran, Iran.
City
Tehran
Postal code
Phone
+98 912 725 3675
Fax
Email
f.baharan@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Fahime Sadat Hosseini Baharanchi
Position
Student in master degree
Other areas of specialty/work
Street address
Faculty of Psychology and Educational Sciences, Kardan St., Jalal Ale-Ahmad St., Shahid Chamran highway , Tehran, Iran.
City
Tehran
Postal code
Phone
+98 912 725 3675
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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