Comparative effect of Dorso lateral prefrontal cortex Transcranial Direct Current Stimulation and Primary Motor Cortex Transcranial Direct Current Stimulation on fatigue in the patients with multiple sclerosis
A Comparative Study of the Effect of Brain Electric Stimulation on Two area motor and DLPFC Fields on Fatigue and Quality of Life in Multiple Sclerosis Patients
Design
Randomized double blind clinical trial parallel group
Settings and conduct
By referring to the Neurological Rehabilitation Research Center and with the completion of satisfaction and fatigue and quality of life and disability questionnaires divided to motor , dorso lateral pre frontal and sham groups, and patients and therapists are not aware of the type of intervention.
Participants/Inclusion and exclusion criteria
inclusion criteria"
1- Age between 18 to 40 years
2-According to Mc Donald 2010 Revision criteria, their multiple sclerosis detected
3-Have received steady medical therapies since the last 6 months.
4-Have experienced fatigue for at least 6 months and have Fatigue Severity Scale more than 5
5-Their extended disability Status Scale is less than 4
exclusion criteria:
1-Multiple sclerosis that has had relaps during the last two months
2 are based on a BECK DEPRESSION INVENTORY scale have depression of more than 19
4. daily sleep rate of EPWORTH of more than 11
5. severe vision defects ,Severe weakness in limb movemen ,Other neurological and neurological diseases
Intervention groups
Transcranial Direct Current Stimulation applied to the DLPFC
Transcranial Direct Current Stimulation applied on the motor area
Sham group by applying Transcranial Direct Current Stimulation Unreal
Main outcome variables
Fatigue, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150302021294N7
Registration date:2018-03-22, 1397/01/02
Registration timing:prospective
Last update:2018-03-22, 1397/01/02
Update count:0
Registration date
2018-03-22, 1397/01/02
Registrant information
Name
Fatemeh Ehsani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
f.ehsani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-07-23, 1397/05/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2018-07-23, 1397/05/01
Trial completion date
empty
Scientific title
Comparative effect of Dorso lateral prefrontal cortex Transcranial Direct Current Stimulation and Primary Motor Cortex Transcranial Direct Current Stimulation on fatigue in the patients with multiple sclerosis
Public title
effect of Transcranial Direct current Stimulation on fatigue and quality of life in multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18-40
FSS>5 at least for 6 month ago
EDSS<4
constant drug therapy at least 6 month ago
diagnosis of multiple sclerosis according to M C DONALD CRITERIA revision 2010
Exclusion criteria:
MULTIPLE SCLEROSIS with relaps period at least 2 month ago
According to BDI have depression>19
according to EPWORTH have sleepness >11
deficit in visual view
deficit in muscle power according to Medical research council score for muscle Power 12/20
Age
From 18 years old to 40 years old
Gender
Both
Phase
0
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization,individual,random number table,randomized permutation blocks(block3), using excel software to generate random number tables
Blinding (investigator's opinion)
Double blinded
Blinding description
All of participants are blind to type of intervention and assessors are blind to type of intervention and experimental conditions
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Semnan Medical University
Street address
Deputy of Research and Technology of Semnan University of Medical Sciences.,After Amir kabir Bridge
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-03-16, 1396/12/25
Ethics committee reference number
ir.semums.rec.1396.219
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G37.8
ICD-10 code description
Other specified demyelinating diseases of central nervous system
Primary outcomes
1
Description
scale of fatigue in FSS
Timepoint
BEFORE OF INTERVENTION,immediate after ,on month after intervention
Method of measurement
questionaree of FSS
2
Description
QUALITY OF LIFE IN MSQOL SCALE
Timepoint
Before of intervention,immediate after,one month after intervention
Method of measurement
QUESTIONAREEOF MSQOL
Secondary outcomes
1
Description
QUALITY OF LIFE MSQOL
Timepoint
Before intervention,immediate after, one month after
Method of measurement
questionaree of MSQOL
Intervention groups
1
Description
Intervention group:First intervention group: transcranial direct current stimulation on dorsolateral prefrontal group with 20 min Exposure duration 1.5 mA
Category
Rehabilitation
2
Description
Intervention group:Direct electrical stimulation of motor area for 20 minutes with an intensity of 1.5 mA
Category
Rehabilitation
3
Description
Control group: The sham group was placed by placing the electrode on the motor or perforontal region by randomly actuating 30 seconds at the beginning of the treatment and being off until the end of the 20 minute treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Next to Nemat Ice Cream., Blvd Ghods., Mashahir Square.,Neuromuscular Rehabilitation Research Center,
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Fax
Email
f.ehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Asgari
Street address
SemnanHeadquarters., Medical Semnan University.,After Amir Kabir Bridge,
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1021
Email
Aasgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Sponsor: country of origin
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damghan Sreet ., Semnan Medical Uneversity,
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1021
Email
fatemehehsani59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Damghan Street.,Semnan Medical University,
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3344 1021
Email
fatemehehsani59@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marzieh Mortezanejad
Position
Stuff
Latest degree
Bachelor
Other areas of specialty/work
Rehabilitation management
Street address
Neuromuscular Rehabilitation Research Center.,Next to Nemat Ice Cream., Ghods Blvd.,Mashahir Square,
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3322 8502
Email
mmortezanejad98@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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