Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Multiple sclerosis Patients with Depression Symptoms in Sina Farshchian Hospital in Hamadan city
Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Multiple sclerosis Patients with Depression Symptoms
Design
A controlled clinical trial with parallel groups, phase 2-3 randomized, on 40 patients with multiple sclerosis with depression. Random blocks were used for randomization
Settings and conduct
This study is performed in Farshchian Hospital in Hamadan. Due to the fact that patients do not know about the assignment of the group, so a one-way blind study is performed. Patients receive 10-minute direct-current electrical stimulation of the brain with a current of 2 mA, and in the control group receive 10 inactive 20-minute sessions with the same device.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study,Patient with multiple sclerosis of any type and with moderate and high depression,Not receive repeated trans cranial magnetic stimulation and electroconvulsive therapy in the past two month.
Exclusion criteria:Having a shunt and any other metal object near the head
Interferon consumption,Pregnant or lactating women,Patients at risk of suicide,Patients with other psychiatric disorders such as bipolar disorder
Intervention groups
20 patients with multiple sclerosis of any type and with moderate to high depression receive direct current electrical stimulation of the brain for 10 sessions of 20 minutes with a current of 2 mA and in the control group receive 10 sessions of inactive 20 minutes with the same device.
Main outcome variables
The score of Montgomery-Asberg Depression Inventory, severity of disability and cognitive function in the two groups of intervention and control before the intervention and after the tenth session are compared.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160523028008N11
Registration date:2021-02-20, 1399/12/02
Registration timing:prospective
Last update:2021-02-20, 1399/12/02
Update count:0
Registration date
2021-02-20, 1399/12/02
Registrant information
Name
Mohammad Faryadras
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3428 9706
Email address
m.faryadras@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Repetitive Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Multiple sclerosis Patients with Depression Symptoms in Sina Farshchian Hospital in Hamadan city
Public title
Transcranial Magnetic Stimulation ( rTMS ) add-on therapy to Standard treatment in Multiple sclerosis Patients with Depression Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Patient with multiple sclerosis of any type and with moderate and high depression
Not receive repeated transcranial magnetic stimulation and electroconvulsive therapy in the past two months
Exclusion criteria:
Having a shunt and any other metal object near the head
Interferon consumption
Pregnant or lactating women
Patients at risk of suicide
Patients with other psychiatric disorders such as bipolar disorder
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to the intervention, patients do not know about the assignment of the group, so a one-way blind study is performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-01-30, 1399/11/11
Ethics committee reference number
IR.UMSHA.REC.1399.925
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Depression rate
Timepoint
before and after 10 sessions of intervention
Method of measurement
Montgomery-Asberg Depression Rating Scale (MADRS)
2
Description
Fatigue severity test
Timepoint
before and after 10 sessions of intervention
Method of measurement
Fatigue Severity Scale
3
Description
Expanded Disability Status Scale
Timepoint
before and after 10 sessions of intervention
Method of measurement
Expanded Disability Status Scale
4
Description
Cognitive Assessment
Timepoint
before and after 10 sessions of intervention
Method of measurement
Montreal Cognitive Assessment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 session of 20 minute of trans cranial direct current stimulation by 2 ma
Category
Treatment - Other
2
Description
Control group: 10 inactive session of 20 minutes by the same deviceCategoryOther
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Amir Keshavarzi
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 1828 5015
Email
drkeshavarzi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadn
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Keshavarzi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81182851015
Email
drkeshavarzi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD