The effect of M1 transcranial direct current stimulation on implicit motor learning in the patients with multiple sclerosis
Design
Non-random(Days of the Week (Even and odd)), without placebo . The sample size of this study is 100 individuals: divided into 2 groups of 50 people.
Settings and conduct
Neuromuscular Rehabilitation Research Center Semnan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
100 patients with Multiple Sclerosis diagnosis.
Inclusion criteria: the age range of 18 to 45 years old; MS patients is detected according to guidelines; have received steady medical and physical therapies since the last 6 months; most are right-handed.
Exclusion criteria: Multiple Sclerosis relapses during the last two months; existence severe visual defect on visual examination; existence severe weakness in limbs movement; other neurological and neurological diseases.
Intervention groups
Control group: In this group, the brain will receive electrical stimulation for twenty minutes, which will increase in intensity for the first 30 seconds, and then will decrease until the patient feels that there is current and will remain the same until the end of treatment.
Intervention group (Brain electrical stimulation): In the intervention group, the active anode electrode is placed on the left side of the brain (C3) and the cathode electrode on the right side of the forearm to stimulate the brain area of the brain. Then an electrical stimulation of 2 mA with a gradual gradient for 20 minutes is applied according to the protocol. Response time is recorded for the task sequences before the intervention, 35 minutes after the intervention and 2 days after the intervention.
Main outcome variables
Brain electrical stimulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N32
Registration date:2018-07-14, 1397/04/23
Registration timing:retrospective
Last update:2018-07-14, 1397/04/23
Update count:0
Registration date
2018-07-14, 1397/04/23
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-02, 1396/09/11
Expected recruitment end date
2018-05-31, 1397/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of M1 transcranial direct current stimulation on implicit motor learning in the patients with multiple sclerosis
Public title
The effect of M1 transcranial direct current stimulation on implicit motor learning in the patients with multiple sclerosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of 18 to 45 years old
MS patients is detected according to guidelines
Have received steady medical and physical therapies since the last 6 months
Most are right-handed
Exclusion criteria:
Multiple Sclerosis relapses during the last two months
Existence severe visual defect on visual examination
Existence severe weakness in limbs movement
Other neurological and neurological diseases
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-12-02, 1396/09/11
Ethics committee reference number
IR.SEMUMS.REC.1396.269
Health conditions studied
1
Description of health condition studied
Multiple sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Brain electrical stimulation
Timepoint
48 and 72 hours after the intervention
Method of measurement
Transcranial Direct Current Stimulation (TDCS)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, the brain will receive electrical stimulation for twenty minutes, which will increase in intensity for the first 30 seconds, and then will decrease until the patient feels that there is current and will remain the same until the end of treatment.
Category
Diagnosis
2
Description
Intervention group (Brain electrical stimulation): In the intervention group, the active anode electrode is placed on the left side of the brain (C3) and the cathode electrode on the right side of the forearm to stimulate the brain area of the brain. Then an electrical stimulation of 2 mA with a gradual gradient for 20 minutes is applied according to the protocol. Response time is recorded for the task sequences before the intervention, 35 minutes after the intervention and 2 days after the intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@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
empty
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 33654180
Email
fatemehehsani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ziba Nazari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Ghods Blvd.
+98 9191310755
What processes are involved for a request to access data/document