Protocol summary
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Study aim
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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)
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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balance parameters
Gait spatial-temporal parameters
General information
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Reason for update
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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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Acronym
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IRCT registration information
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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
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Registration date
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2023-09-19, 1402/06/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-09-21, 1402/06/30
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Expected recruitment end date
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2024-01-20, 1402/10/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Comparing the effects of trans-cranial direct current stimulation in patients with multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-11, 1402/03/21
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1402.161
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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F06.8
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ICD-10 code description
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Other specified mental disorders due to brain damage and dysfunction and to physical disease
Primary outcomes
1
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Description
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Gait spatial-temporal parameters
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Timepoint
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Before intervention-After intervention
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Method of measurement
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Motion analyze
2
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Description
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Balance parameters
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Timepoint
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Before intervention-After intervention
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Method of measurement
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Force plate
Secondary outcomes
1
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Description
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Timepoint
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Method of measurement
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Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available