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IRCT20200125046249N2 IRCT 2025-05-01 Shahid Beheshti University of Medical Sciences Comparison of the effect of using simultaneous or single anodal tDCS on the dorsolateral pre frontal cortex area( DLPFC) and cerebellum on brain neuromodulatation, balance and gait in people with multiple sclerosis tDCS Comparison of the effect of using simultaneous or single anodal tDCS on the dorsolateral pre frontal cortex area( DLPFC) and cerebellum on neuromodulation, balance and gait in people with relapsing-remitting multiple sclerosis: a double-blind clinical study 2025-05-22 anticipated 60 Complete https://irct.ir/trial/76382 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible cases will be randomly assigned to three tDCS groups of cerebellum and dorsolateral prefrontal cortex or cerebellum and dorsolateral prefrontal cortex, each one alone with block randomization. A block size of four will be used for randomization, and sequences will be calculated by random assignment software version 2.0. Coordinators will have exclusive access to the numbered and sealed envelopes that will indicate each patient's treatment assignment, Blinding description: Patients do not know which group they are in and what intervention they are receiving. Also, the outcome assessor and data analyst do not know about the allocation of groups. N/A Multiple sclerosis(MS). Intervention 1: Intervention group: Task-oriented training + anodal tDCS cerebellum and DLPFC. Intervention 2: Intervention group: Task-oriented training + anodal tDCS cerebellum. Intervention 3: Intervention group: DLPFC anodal tDCS. 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 There is no further information.
public Minoo khalkhali Zavieh
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 minoo_kh@yahoo.com Shahid Beheshti University of Medical Sciences scientific minoo khalkhali zavieh
Imam Hossein (AS) Square, Damavand Street (New Tehran), in front of Bo Ali Hospital, Faculty of Rehabilitation Sciences, Shahid Beheshti University of Medical Sciences
Tehran Iran (Islamic Republic of) 1616913111 +98 21 7754 2057 faezeh_abaschian@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age between 20-55 years old Presence of relapsing-remitting MS The average level of disability is between 2 and 5 in EDSS Having at least third middle school education in order to fill out the questionnaires Receiving stable drug treatments in the last 6 months Having a balance disorder based on the timed up and go test Absence of fixed contract not suffering from other neurological disorders Absence of obvious postural disorders in the spine No history of lower limb surgery Absence of cardiovascular diseases and diabetes Absence of any intracranial metal implants or other implanted devices such as pacemakers, cochlear implants Inability to stand or walk with or without the use of an assistive device 20 years 55 years Both Multiple sclerosis attack within the last month Not being in the stable phase of MS pregnancy Dissatisfaction with treatment Inability to stand or walk with or without the use of an assistive device G35 Multiple sclerosis Rehabilitation Rehabilitation Rehabilitation Intervention group: Task-oriented training + anodal tDCS cerebellum and DLPFC Intervention group: Task-oriented training + anodal tDCS cerebellum Intervention group: DLPFC anodal tDCS Balance score in Timed up and go test. Timepoint: Balance measurement at the beginning of the study (before the start of the intervention) and after 4 weeks and one month after the last treatment session. Method of measurement: Timed up and go test (TUG). Investigating static balance along with cognitive work through pressure point fluctuations on the force plate. Timepoint: Measuring static balance along with cognitive work at the beginning of the study (before the start of the intervention) and 4 weeks after the treatment and one month after the last treatment session. Method of measurement: Force plate. Investigating spasticity by modified Ashworth questionnaire. Timepoint: Assessment of spasticity at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session. Method of measurement: Modified Ashworth scale. Assessment of gait by 12-item gait scale in multiple sclerosis (12-MSWS). Timepoint: Assessment of walking at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session. Method of measurement: 12-item walking scale in people with multiple sclerosis(12-MSWS). Assessment of neuromodulation by somatosensory evoked potentials. Timepoint: Evaluation of neuromodulation at the beginning of the study (before the start of the intervention), 4 weeks after the treatment and one month after the last treatment session. Method of measurement: Somatosensory evoked potential apparatus. Examining the level of fatigue using the modified MS fatigue questionnaire(MFIS). Timepoint: Evaluation of fatigue at the beginning of the study (before the intervention), 4 weeks after the treatment and one month after the last treatment session. Method of measurement: Modified fatigue impact scale(MFIS). Shahid Beheshti University of Medical Sciences Approved 2024-12-14 Ethics committee of Shahid Beheshti University of Medical Sciences Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences Tehran Tehran Iran (Islamic Republic of)