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IRCT20220111053689N1 IRCT 2022-03-03 Shahid Beheshti University of Medical Sciences Comparison of the effect of cerebellum tDCS and prefrontal in patients with multiple sclerosis Comparison of the effect of cerebellum tDCS and prefrontal on gait parameters, balance and fatigue in patients with multiple sclerosis 2022-02-09 anticipated 51 Complete https://irct.ir/trial/61409 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Multiple sclerosis. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet.
public Narges Jahantigh Akbari
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 8496 n.jahantigh.akbari@gmail.com Shahid Beheshti University of Medical Sciences scientific Narges Jahantigh Akbari
Shahid Beheshti University of Medical Sciences, next to Taleghani Hospital, Yemen Street, Shahid Chamran Highway
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 8496 n.jahantigh.akbari@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of MS by a neurologist Relapsing Remitting MS and secondary progressive MS The EDSS score should be between 3.5 to 5 18 years 50 years Both Severe mental and cardiac patients Patients who experience severe cognitive impairment and depression Orthopedic disorders that can negatively affect balance 8A40 Multiple sclerosis or other white matter disorders Rehabilitation Rehabilitation Rehabilitation 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. 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. 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. Balance. Timepoint: Before intervention-After intervention. Method of measurement: Force plate. Gait parameters. Timepoint: Before intervention-After intervention. Method of measurement: Motion analyze. Balance. Timepoint: Before intervention-After intervention. Method of measurement: berg balance scale. Balance. Timepoint: Before intervention-After intervention. Method of measurement: Timed Up و Go test. Fatigue. Timepoint: Before intervention-After intervention. Method of measurement: Fatigue Severity Scale (FSS). Dr. Afshin Zarghi Approved 2021-11-07 Ethics Committee of Shahid Beheshti University of Medical Sciences Imam Hossein Square, Damavand St. (New Tehran), in front of Bouali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)