Evaluation of the effects of repetitive transcranial magnetic stimulation on working memory performance in patients with multiple sclerosis by source localization with EEG and MRI
Evaluation of the effects of repetitive transcranial magnetic stimulation on working memory performance in patients with multiple sclerosis by source localization with EEG and MRI
Design
Phase 2-3 clinical trials are performed on 60 patients in parallel groups to evaluate the effect of repetitive brain stimulation on working memory.
Settings and conduct
This study is performed in Kashani Hospital. Patients with MS will be treated for brain stimulation in two ways, and the amount of working memory before and after treatment will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of MS by a neurologist, age 18 to 65 years, informed consent to participate in the study and have a minimum literacy
Exclusion criteria: Existence of serious suicide plan or thoughts, use of anti-depressant and anti-anxiety drugs, pregnancy or breastfeeding, and contraindications to using the device
Intervention groups
Intervention group 1: Patients in this group undergo brain waves and brain anatomy in areas related to working memory before interventions. They will then undergo 5 sessions of treatment by repeated transcranial magnetic stimulation with routine location (method 10-20). Intervention group 2: Patients in this group undergo brain waves and brain anatomy in areas related to working memory before interventions. They will then undergo 5 therapeutic sessions by repeated transcranial magnetic stimulation using location-based mapping. At the end of the last session, the MRI and MRI will be re-examined, and the brain waves and anatomy of the working memory-related areas will be examined. Control group: In this group, only healthy people will be examined by MRI and brain anatomy by MRI, and brain waves and anatomy of areas related to their working memory will be examined.
Main outcome variables
Electroencephalogram signals, brain anatomy in memory-related areas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210614051574N11
Registration date:2022-04-27, 1401/02/07
Registration timing:prospective
Last update:2022-04-27, 1401/02/07
Update count:0
Registration date
2022-04-27, 1401/02/07
Registrant information
Name
Ghasem Mohammadsharifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4005
Email address
mohammadsharifi.ghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-07-20, 1401/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of repetitive transcranial magnetic stimulation on working memory performance in patients with multiple sclerosis by source localization with EEG and MRI
Public title
Repetitive transcranial magnetic stimulation and working memory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS by a neurologist
Age 18 to 65 years
Informed consent to participate in the study
Have a minimum literacy
Exclusion criteria:
Existence of a suicidal plan or serious thoughts
Taking antidepressants and anti-anxiety drugs
Pregnancy or breastfeeding
Contraindications to the use of the device
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences, Hezar Jarib Ave., Esfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-05-20, 1400/02/30
Ethics committee reference number
IR.MUI.MED.REC.1400.126
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Electroencephalogram signals
Timepoint
Before starting treatment and after the last session of brain stimulation
Method of measurement
By electroencephalogram
2
Description
Anatomy of the brain in areas related to memory
Timepoint
Before starting treatment and after the last session of brain stimulation
Method of measurement
MRI machine
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients in this group undergo brain waves and brain anatomy in areas related to working memory before interventions. They will then undergo 5 sessions of treatment by repeated transcranial magnetic stimulation with routine location (method 10-20). After the last session, they will be re-examined on MRI and MRI and brain waves and anatomy Work memory related will be examined.
Category
Treatment - Devices
2
Description
Intervention group 2: Patients in this group undergo brain waves and brain anatomy in areas related to working memory before interventions. They will then undergo 5 therapeutic sessions by repeated transcranial magnetic stimulation using location-based mapping. At the end of the last session, the MRI and MRI will be re-examined, and the brain waves and anatomy of the working memory-related areas will be examined.
Category
Treatment - Other
3
Description
Control group: In this group, only healthy people will be examined by MRI and brain anatomy by MRI, and brain waves and anatomy of areas related to their working memory will be examined.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Majid Barakatin
Street address
No. 22, Roshd Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0042
Email
parsa.alinezhad85@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave,. Daneshgah Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673118
Phone
+98 31 3668 0048
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Majid Barakatin
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Barakatin
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Majid Barakatin
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No. 7, Hezar Jarib Ave., Daneshgah Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3729 4005
Fax
Email
mohammadsharifi.ghasem@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after people have requested.
When the data will become available and for how long
Six months after publishing the results.
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Scientific uses
From where data/document is obtainable
Website of the Research Committee of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Clear request on the site to access the data by the individual and then review the request by the research assistant within 2 weeks and then allow access to the data.