In recent years, the use of brain magnetic stimulation for cognitive rehabilitation and movement improvement in patients with different nerve system diseases has an interest.
Transcranial magnetic stimulation is a non-invasive and painless method which is used to stimulate brain cortex.
MS patients suffer from different cognitive disorder including impairment of information processing speed and working memory and they also suffer from movement disorder.
Motor imagery which is a part of high cognitive function is impaired in MS patients. There is close connection between motor imagery and movement preparing and executing regarding activated cortex sites and active duration.
It has been shown that motor imagery improvement has positive effect on movement execution. since there is no certain treatment for this disease and it has an unknown etiology , and with consideration of positive effect of rTMS, This research is supposed to make use of this technique for motor imagery and execution improvement.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013042313100N1
Registration date:2013-07-06, 1392/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-06, 1392/04/15
Registrant information
Name
Mahdieh Azin
Name of organization / entity
Neuroscience Research Center- Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1226 4196
Email address
mahdieh.azin@collegian.kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Neuroscience Research Center
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of transcranial magnetic stimulation effect on motor imagery rehabilitation and movement improvment in multiple sclerosis patients
Public title
study of transcranial magnetic stimulation effect on motor imagery rehabilitation and movement improvment in multiple sclerosis patients
Purpose
Treatment
Inclusion/Exclusion criteria
All patients (20 to 40 years old ) met the Mc Donald criteria for diagnosis of MS.All of them belong to relapsing remitting MS subgroup.
The study exclusion criteria included patients with EDSS > 3.5; new clinical attack during 3 months prior to the study; other neurological diseases (stroke, seizure, etc.); head trauma, chronic psychiatric disorder. Patients were right-handed based on the Edinburgh Handedness Inventory. Fatigue score based on Fatigue Severity Scale questionnaire should be less than 37. Depression score based on Beck Depression questionnaire should be less than 21. Mini mental state examination score should be more than 24.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Kerman University of Medical Science
Street address
Ebn Sina St.
City
Kerman
Postal code
7619813159
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
91/270/کا
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Primary outcomes
1
Description
mental rotation ability
Timepoint
befor rTMS implementation and after the 10th rTMS session
Method of measurement
Reaction time and accuracy (percent of correct response) were recorded
2
Description
upper limb imagery chronometry
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
(real performance-motor imagery)/real performance
3
Description
upper limb function
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
number of moved blocks in 1 minute
4
Description
upper limb function
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
recorded time for moving nine pegs
5
Description
lower limbs function
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
recorded time for walking 25 foots
Secondary outcomes
1
Description
PASAT score
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
total number of accurate sum
2
Description
motor and visual imagery vividness
Timepoint
before rTMS implementation
Method of measurement
kinesthetic and visual imagery questionnaire
3
Description
global cognitive function
Timepoint
before rTMS implementation
Method of measurement
mini mental state examination
4
Description
depression score
Timepoint
before rTMS implementation
Method of measurement
beck depression questionnaire
5
Description
fatigue score
Timepoint
before rTMS implementation
Method of measurement
fatigue Severity scale questionnaire
6
Description
SDMT score
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
number of correct digits in 90 second
7
Description
Brief visuospatial memory test-revised score
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
number of correct responses after 25 minutes
8
Description
judgment of line orientation score
Timepoint
before rTMS implementation and after the 10th rTMS session
Method of measurement
number of correct angles
Intervention groups
1
Description
Intervention: transcranial magnetic stimulation. Duration: 10 sessions( 5 sessions in one week and other 5 sessions in next week).
Category
Rehabilitation
2
Description
Control: no treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat clinic
Full name of responsible person
Dr. Farhad Iranmanesh
Street address
Ebn Sina St.
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman medical university-dean of research
Full name of responsible person
sedigheh khezri
Street address
Ebn Sina St.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman medical university-dean of research
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
Kerman Neuroscience Research Center
Full name of responsible person
Nasser Zangiabadi
Position
Assistant professor of neurology
Other areas of specialty/work
Street address
Ebn Sina St.
City
Kerman
Postal code
7619813159
Phone
+98 34 1226 4271
Fax
Email
nzangiabadi1@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
Nasser Zangiabadi
Position
Assistant professor of neurology
Other areas of specialty/work
Street address
Ebn Sina St.
City
Kerman
Postal code
7619813159
Phone
+98 34 1226 4271
Fax
Email
nzangiabadi1@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman Neuroscience Research Center
Full name of responsible person
Mahdieh Azin
Position
PhD student of neuroscience
Other areas of specialty/work
Street address
Ebn Sina St.
City
Kerman
Postal code
Phone
+98 34 1226 4271
Fax
Email
mahdieh.azin@gmail.com; azin.mahdieh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)