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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.
Clinical trial with a control group, parallel groups, double-blind, randomization with a simple pseudo-randomization method will be on 51 patients. Treatment will be 20 min of stimulation, 1.5 mA and balance exercises.
SubjectsClinical trial with a control group, parallel groups, double-blind, randomization with a simple pseudo-randomization method will be randomly divided into three groups, DLPFC, Cerebellum tDCS and control groupon 51 patients. The treatment planTreatment will includedbe 20 minutesmin of brain stimulation with, 1.5 mA tDCS and 10 minutes of balance trainingexercises.
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.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی، دو سویه کور، تصادفی سازی با یک روش ساده شبه تصادفی سازی بر روی 51 بیمار خواهد بود. درمان شامل 20 دقیقه تحریک، 1.5 میلی آمپر و تمرینات تعادلی خواهد بود.
افراد مورد مطالعه به 3 گروهDLPFC tDCS ، Cerebellum tDCS وکارآزمایی بالینی دارای گروه کنترل بصورت، با گروه های موازی، دو سویه کور، تصادفی تقسیم خواهند شد.برنامه درمانیسازی با یک روش ساده شبه تصادفی سازی بر روی 51 بیمار خواهد بود. درمان شامل ۲۰20 دقیقه تحریک مغزی با tDCS با شدت، 1.5 میلی آمپر و ده دقیقه تمرینات تعادلی خواهد بود.
General information
Hello
Good time, In the initial study, intervention groups were considered due to time limitations and the number of referring patients. But during the study process, a number of patients were examined as a control group in order to have a better evaluation of the comparison of the results and also to examine the real effect of tDCS. On the other hand, in the control group, the device was turned off. Therefore, it is requested to add the control group, and also according to the addition of the control group, a number should be added to the sample size. Thank you for your kindness, dear colleague.
Hello,
In the design of the study, 10 minutes for balance exercises was a typing mistake and it was 20 minutes of tDCS and balance exercises, and please correct it. Thanks.
Hello Good time, In the initial study, intervention groups were considered due to time limitations and the number of referring patients. But during the study process, a number of patients were examined as a control group in order to have a better evaluationdesign of the comparison of the resultsstudy, 10 minutes for balance exercises was a typing mistake and also to examine the real effectit was 20 minutes of tDCS. On the other hand, in the control group, the device was turned off. Therefore, it is requested to add the control group and balance exercises, and also according to the addition of the control group, a number should be added to the sample sizeplease correct it. Thank you for your kindness, dear colleagueThanks.
با سلام
وقتتون بخیر، در مطالعه اولیه به دلیل محدودیت زمانی و تعداد بیماران مراجعه کننده، گروه های مداخله در نظر گرفته شد ولی در طول روند مطالعه، تعدادی از بیماران به عنوان گروه کنترل بررسی شد تا ارزیابی بهتری از مقایسه نتایج و نیز بررسی تاثیر واقعی tDCS داشته باشیم . از طرف دیگر، در گروه کنترل دستگاه خاموش بود. لذا درخواست می گردد گروه کنترل اضافه گردد و همچنین با توجه به اضافه شدن گروه کنترل، تعدادی به حجم نمونه نیز اضافه شود با تشکر از لطف شما همکار محترم.
با سلام و عرض ادب
در طراحی مطالعه، 10 دقیقه برای تمرینات تعادلی اشتباه تایپی بوده است و بصورت 20 دقیقه tDCS و تمرینات تعادلی بوده است و لطفا اصلاح شود. با تشکر
با سلام وقتتون بخیر،و عرض ادب در مطالعه اولیه به دلیل محدودیت زمانی و تعداد بیماران مراجعه کننده، گروه های مداخله در نظر گرفته شد ولی در طول روندطراحی مطالعه، تعدادی از بیماران به عنوان گروه کنترل بررسی شد تا ارزیابی بهتری از مقایسه نتایج10 دقیقه برای تمرینات تعادلی اشتباه تایپی بوده است و نیز بررسی تاثیر واقعیبصورت 20 دقیقه tDCS داشته باشیم . از طرف دیگر، در گروه کنترل دستگاه خاموش بود. لذا درخواست می گردد گروه کنترل اضافه گرددو تمرینات تعادلی بوده است و همچنین با توجه به اضافه شدن گروه کنترل، تعدادی به حجم نمونه نیز اضافهلطفا اصلاح شود. با تشکر از لطف شما همکار محترم.
Protocol summary
Study aim
Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters, balance and fatigue in patients with Multiple Sclerosis
Design
Clinical trial with a control group, parallel groups, double-blind, randomization with a simple pseudo-randomization method will be on 51 patients. Treatment will be 20 min of stimulation, 1.5 mA and balance exercises.
Settings and conduct
Men and women with MS living in Tehran who voluntarily want to participate in this study and meet the inclusion criteria, constitute the statistical population. This double-blind randomized clinical trial will be performed at Shahid Beheshti School of Rehabilitation of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of MS by a neurologist; MS type relapsing remitting and secondary progressive type; the EDSS score should be between 3.5 and 6.5; age range between 18 to 50 years.
Exclusion criteria: severe mental and cardiac patients; cognitive impairment and severe depression; orthopedic disorders.
Intervention groups
DLPFC tDCS group:
The tDCS anodal will placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region.
cerebellum tDCS group:
The tDCS anodal will placed 1-2 cm below and 3-4 cm laterally inion (right) to stimulate the right cerebellum and the reference electrode across buccinator muscle of the same side.
In control group: The “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. The electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation. The stimulator will be turned off after 30seconds of stimulation without the participant’s knowledge.
Main outcome variables
Balance; gait parameters; fatigue
General information
Reason for update
Hello,
In the design of the study, 10 minutes for balance exercises was a typing mistake and it was 20 minutes of tDCS and balance exercises, and please correct it. Thanks.
Acronym
IRCT registration information
IRCT registration number:IRCT20220111053689N1
Registration date:2022-03-03, 1400/12/12
Registration timing:prospective
Last update:2023-09-26, 1402/07/04
Update count:3
Registration date
2022-03-03, 1400/12/12
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
2022-02-09, 1400/11/20
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
2022-03-11, 1400/12/20
Actual recruitment end date
2023-01-20, 1401/10/30
Trial completion date
empty
Scientific title
Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters, balance and fatigue in patients with multiple sclerosis
Public title
Comparison of the effect of cerebellum tDCS and prefrontal 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
The EDSS score should be between 3.5 to 5
Exclusion criteria:
Severe mental and cardiac patients
Patients who experience severe cognitive impairment and depression
Orthopedic disorders that can negatively affect balance
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
51
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly will be assigned through simple pseudo-randomization procedures using computer-generated list of random numbers to one of the three groups: (1) the group will received a-tDCS over dorsolateral prefrontal cortex and balance training, (2) the group will received a-tDCS over cerebellum and balance training and (3) the control group will received sham a-tDCS and balance training. The pseudo-randomized numbers of 1, 2 and 3 will be applied by one of the researchers to assign individuals to these groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The data analyzer will be blinded to the allocation of
patients to the two groups of intervention and control,
and data collection will be done in a separate room to
the treatment department also, patients will be blinded
depending on the treatment they receive and each of
them will be treated in a separate room.
Placebo
Not 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
2021-11-07, 1400/08/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.499
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
8A40
ICD-10 code description
Multiple sclerosis or other white matter disorders
Primary outcomes
1
Description
Balance
Timepoint
Before intervention-After intervention
Method of measurement
Force plate
2
Description
Gait parameters
Timepoint
Before intervention-After intervention
Method of measurement
Motion analyze
3
Description
Balance
Timepoint
Before intervention-After intervention
Method of measurement
berg balance scale
4
Description
balance
Timepoint
Before intervention-After intervention
Method of measurement
Timed Up و Go test
5
Description
fatigue
Timepoint
Before intervention-After intervention
Method of measurement
Fatigue Severity Scale (FSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: in this group, the anodal tDCS is placed to stimulate the left dorsolateral prefrontal cortex (left DLPFC) across the F3 region and the reference electrode across the right supraorbital region.
Category
Rehabilitation
2
Description
Intervention group 2: 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 the ipsilateral muscle of the ipsilateral or supraorbital or forehead area.
Category
Rehabilitation
3
Description
Control group: “Fade-in Short stimulation Fade-out (FiSsFo) approach” will be used to maintain the blinding integrity and thus will created the assumed initial cutaneous sensations. In the sham a-tDCS group, while the electrodes will be randomly placed in the same positions for cerebellum or DLPFC stimulation, the stimulator will turned off after 30seconds of stimulation without the participant’s knowledge.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
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
Shahid Beheshti University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Dr. Afshin Zarghi
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
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
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
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
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