Comparing the effects of multi-session anodal trans-cranial direct current stimulation of cerebellum and dorsolateral prefrontal cortices on balance and gait spatial-temporal parameters in patients with multiple sclerosis
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Protocol summary
Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will included 20 minutes of brain stimulation with 1.5 mA tDCS and 10 minutes of balance training.
Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will be included 20 minutes of brain stimulation with 1.5 mA tDCS and balance training.
Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will be included 20 minutes of brain stimulation with 1.5 mA tDCS and 10 minutes of balance training.
افراد مورد مطالعه به 3 گروهDLPFC tDCS ، Cerebellum tDCS و گروه کنترل بصورت تصادفی تقسیم خواهند شد.برنامه درمانی شامل ۲۰ دقیقه تحریک مغزی با tDCS با شدت 1.5 میلی آمپر و ده دقیقه تمرینات تعادلی خواهد بود.
افراد مورد مطالعه به 3 گروهDLPFC tDCS ، Cerebellum tDCS و گروه کنترل بصورت تصادفی تقسیم خواهند شد.برنامه درمانی شامل ۲۰ دقیقه تحریک مغزی با tDCS با شدت 1.5 میلی آمپر و تمرینات تعادلی خواهد بود.
افراد مورد مطالعه به 3 گروهDLPFC tDCS ، Cerebellum tDCS و گروه کنترل بصورت تصادفی تقسیم خواهند شد.برنامه درمانی شامل ۲۰ دقیقه تحریک مغزی با tDCS با شدت 1.5 میلی آمپر و ده دقیقه تمرینات تعادلی خواهد بود.
General information
empty
10 minutes for balance exercises was a typing and writing mistake and it was corrected to 20 minutes of tDCS and balance exercises.
10 minutes for balance exercises was a typing and writing mistake and it was corrected to 20 minutes of tDCS and balance exercises.
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10 دقیقه برای تمرینات تعادلی اشتباه تایپی و نوشتاری بوده است و بصورت 20 دقیقه tDCS و تمرینات تعادلی بوده اصلاح شد.
10 دقیقه برای تمرینات تعادلی اشتباه تایپی و نوشتاری بوده است و بصورت 20 دقیقه tDCS و تمرینات تعادلی بوده اصلاح شد.
Protocol summary
Study aim
Comparing the effects of multi-session anodal trans-cranial direct current stimulation (tDCS) of cerebellum and dorsolateral prefrontal cortices (DLPFC) on balance and gait spatial-temporal parameters in patients with multiple sclerosis (MS)
Design
Subjects will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control group. The treatment plan will be included 20 minutes of brain stimulation with 1.5 mA tDCS and balance training.
Settings and conduct
Multiple sclerosis (MS) patients in Tehran will participate. This double-blind randomized controlled trial (RCT) will be conducted in Shahid Beheshti University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
diagnosis of MS by a neurologist; MS type relapsing remitting and secondary progressive type; age range between 18 to 60 years. Exclusion criteria: patients who experience cognitive impairment and severe depression; orthopedic disorders that can negatively affect balance.
Intervention groups
DLPFC tDCS group: electrode is placed to stimulate the DLPFC and the reference electrode across the right supraorbital region. Cerebellum tDCS group: electrode is placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across supraorbital.
In the sham or control tDCS group: the “Fade-in Short stimulation Fade-out (FiSsFo) approach” was used to maintain the blinding integrity and thus create the assumed initial cutaneous sensations. In the sham a-tDCS group, while the electrodes were randomly placed in the same positions for cerebellum or DLPFC stimulation, the stimulator was turned off after 30seconds of stimulation without the participant’s knowledge.
10 minutes for balance exercises was a typing and writing mistake and it was corrected to 20 minutes of tDCS and balance exercises.
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053689N2
Registration date:2023-09-19, 1402/06/28
Registration timing:prospective
Last update:2024-03-14, 1402/12/24
Update count:1
Registration date
2023-09-19, 1402/06/28
Registrant information
Name
narges jahantigh akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7754 8496
Email address
n.jahantigh.akbari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of multi-session anodal trans-cranial direct current stimulation of cerebellum and dorsolateral prefrontal cortices on balance and gait spatial-temporal parameters in patients with multiple sclerosis
Public title
Comparing the effects of trans-cranial direct current stimulation in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of MS by a neurologist
Relapsing Remitting MS and secondary progressive MS
EDSS score should be between 3.5 to 5
Ability to stand for 30 seconds and walk 10 meters with or without an aid
Exclusion criteria:
Patients with mental disorders
Patients with orthopedic problems
cardiovascular patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the permuted block randomization technique with a block size of 3 will be used in such a way that patients are first divided into homogeneous groups according to important background factors, and in each class, 3 samples per block will be included. A total of 16 blocks of 3 will be randomly assigned to each of the groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyst will be blinded to the allocation of patients to three groups. Data collection will be done in a separate environment from the treatment environment. Also, the patients will be blinded in three intervention and control groups, and each of them will be treated in separate rooms.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Imam Hossein Square, Damavand St. (New Tehran), in front of Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1616913111
Approval date
2023-06-11, 1402/03/21
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.161
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
F06.8
ICD-10 code description
Other specified mental disorders due to brain damage and dysfunction and to physical disease
Primary outcomes
1
Description
Gait spatial-temporal parameters
Timepoint
Before intervention-After intervention
Method of measurement
Motion analyze
2
Description
Balance parameters
Timepoint
Before intervention-After intervention
Method of measurement
Force plate
Secondary outcomes
1
Description
Timepoint
Method of measurement
Intervention groups
1
Description
Intervention group: DLPFC tDCS group: In this group, the tDCS anodal will place to stimulate the left dorsolateral prefrontal cortex (left DLPFC), using the international system of 10-20 electroencephalography throughout the F3 area and the reference electrode across the right supraorbital region. The anode electrode in the size of 5 x 5 cm and the reference electrode in the size of 5 x 5 cm will be immersed in the isotonic sodium chloride solution and will be placed in the desired areas using the international 10-20 electroencephalography system.
Category
Rehabilitation
2
Description
Intervention group: cerebellum tDCS group: In this group, the tDCS anodal is placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across supraorbital area. Anode electrode in size 5 x 5 cm and reference electrode in size 5 x 7 cm are immersed in isotonic sodium chloride solution and will be placed in the desired areas using the international 10-20 electroencephalography system.
Category
Rehabilitation
3
Description
Control group: In the sham or control tDCS group: the “Fade-in Short stimulation Fade-out (FiSsFo) approach” was used to maintain the blinding integrity and thus create the assumed initial cutaneous sensations. In the sham a-tDCS group, while the electrodes were randomly placed in the same positions for cerebellum or DLPFC stimulation, the stimulator was turned off after 30seconds of stimulation without the participant’s knowledge.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of rehabilitation of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Street address
Imam Hossein Hospital, at the beginning of Shahid Madani Street, Imam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand street, Emam Hossein square, Tehran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand street, Emam Hossein square, Tehran.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Jahantigh Akbari
Position
researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 8496
Email
n.jahantigh.akbari@gmail.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