Protocol summary
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Study aim
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Comparison of the effect of Cerebellum tDCS and Prefrontal tDCS on gait parameters, balance and fatigue in patients with Multiple Sclerosis
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Design
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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.
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Settings and conduct
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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.
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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; 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.
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Intervention groups
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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.
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Main outcome variables
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Balance; gait parameters; fatigue
General information
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-03-03, 1400/12/12
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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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2022-02-09, 1400/11/20
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Expected recruitment end date
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2022-06-20, 1401/03/30
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Actual recruitment start date
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2022-03-11, 1400/12/20
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Actual recruitment end date
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2023-01-20, 1401/10/30
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Trial completion date
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empty
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Scientific title
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Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters, balance and fatigue in patients with multiple sclerosis
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Public title
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Comparison of the effect of cerebellum tDCS and prefrontal 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
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
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Age
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From 18 years old to 50 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
- Data analyser
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Sample size
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Target sample size:
51
Actual sample size reached:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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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 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.
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Placebo
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Not 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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2021-11-07, 1400/08/16
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1400.499
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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8A40
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ICD-10 code description
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Multiple sclerosis or other white matter disorders
Primary outcomes
1
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Description
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Balance
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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
2
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Description
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Gait 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
3
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Description
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Balance
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Timepoint
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Before intervention-After intervention
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Method of measurement
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berg balance scale
4
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Description
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balance
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Timepoint
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Before intervention-After intervention
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Method of measurement
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Timed Up و Go test
5
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Description
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fatigue
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Timepoint
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Before intervention-After intervention
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Method of measurement
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Fatigue Severity Scale (FSS)
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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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.
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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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Shahid Beheshti University of Medical Sciences
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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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No
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Title of funding source
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Dr. Afshin Zarghi
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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