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IRCT20220803055606N3 IRCT 2025-09-20 Shahid Beheshti University of Medical Sciences Comparison of Transcranial Direct Current Stimulation (tDCS) Alone and Combined with Cognitive Rehabilitation on Improving Attention, Memory, and Inhibitory Control in Patients with Multiple Sclerosis MS-NEURO The Effect of Trans-cranial Direct Current Stimulation and Cognitive Rehabilitation on Cognitive Functions and Neuronal plasticity in Patients with Multiple Sclerosis: A Randomized Controlled Trial 2025-09-23 anticipated 45 Complete https://irct.ir/trial/85374 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a randomized, double-blind, parallel-group clinical trial. Patients with multiple sclerosis will be randomly assigned to three groups (transcranial direct current stimulation, transcranial direct current stimulation combined with cognitive rehabilitation, and sham). The unique feature of this trial is the simultaneous use of a non-pharmacological intervention (tDCS) combined with cognitive rehabilitation, along with the assessment of neuroplasticity biomarkers (BDNF and DTI), Randomization description: Randomization will be performed using permuted block randomization. The unit of randomization is individual. Block sizes will be randomly varied and patients will be allocated to three groups (tDCS, tDCS+Rehacom, Sham). The random sequence will be generated using statistical software. Allocation concealment will be ensured using opaque sealed envelopes that are opened only at the time of patient enrollment. The referring neurologist, the patient, and the cognitive assessor will all be blinded to the group assignments, Blinding description: In this study, patients are blinded to their allocation to the active or sham stimulation groups (participant blinding). The clinicians and staff responsible for administering tDCS sessions are blinded by using preprogrammed devices with random codes that conceal whether the stimulation is active or sham (care provider blinding). The principal investigator remains unaware of patient allocation throughout the data collection process due to the use of coded randomization and sealed opaque envelopes (investigator blinding). Outcome assessors who conduct neurocognitive tests and questionnaires are blinded to patient group assignment (outcome assessor blinding). Data analysts receive coded datasets and perform statistical analyses without knowledge of group allocation (data analyst blinding). No independent Data Safety and Monitoring Committee (DSMC) has been established for this study. N/A Multiple Sclerosis. Intervention 1: First intervention group: Patients will undergo ten sessions of transcranial direct current stimulation (tDCS). Each session lasts 30 minutes over two weeks (five sessions per week). The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3 according to the 10-20 system) and the cathodal electrode over the right shoulder. Stimulation intensity is 2 mA. Intervention 2: Second intervention group: Intervention group 2: Patients will receive ten sessions of transcranial direct current stimulation (tDCS) as in group 1, combined with cognitive rehabilitation using Rehacom software. Training modules focus on attention, memory, and inhibitory control during the same two-week period. Intervention 3: Control group: Control group: Patients will undergo ten sessions of sham transcranial direct current stimulation. Electrodes are placed in the same positions as in the intervention groups, but the current is delivered only for the initial 30 seconds and then switched off, producing no physiological effect. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical considerations, patient confidentiality, and restrictions related to privacy protection, individual participant data will not be shared. No further information is available.
public Dr. Mehrdad Roozbeh
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 mehrdadroozbeh@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Mehrdad Roozbeh
Loqman Hakim Hospital, Kamali Street, Lashgar Crossroads
Tehran Iran (Islamic Republic of) 1333635445 +98 21 5541 9005 mehrdadroozbeh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Diagnosis of relapsing remitting multiple sclerosis (RRMS) by a neurologist Age between 18 and 50 years Mild disability with EDSS less than 5 Presence of cognitive impairment based on neurocognitive tests (more than 2 SD below the mean in attention or inhibitory control) Willingness and informed consent to participate in the study 18 years 50 years Both Presence of psychiatric disorder requiring antipsychotic treatment History of seizure or epilepsy Left handed individuals Recent MS relapse in the past month requiring steroid therapy Pregnancy History of brain surgery or intracranial metallic clip Unwillingness or inability to complete intervention sessions G35 Multiple sclerosis Treatment - Devices Treatment - Devices Placebo First intervention group: Patients will undergo ten sessions of transcranial direct current stimulation (tDCS). Each session lasts 30 minutes over two weeks (five sessions per week). The anodal electrode is placed over the left dorsolateral prefrontal cortex (F3 according to the 10-20 system) and the cathodal electrode over the right shoulder. Stimulation intensity is 2 mA. Second intervention group: Intervention group 2: Patients will receive ten sessions of transcranial direct current stimulation (tDCS) as in group 1, combined with cognitive rehabilitation using Rehacom software. Training modules focus on attention, memory, and inhibitory control during the same two-week period. Control group: Control group: Patients will undergo ten sessions of sham transcranial direct current stimulation. Electrodes are placed in the same positions as in the intervention groups, but the current is delivered only for the initial 30 seconds and then switched off, producing no physiological effect. Change in attention score on the Integrated Visual and Auditory Continuous Performance Test in patients with multiple sclerosis. Timepoint: At baseline before starting the intervention; and immediately after completion of ten intervention sessions over two weeks. Method of measurement: Administration of the Integrated Visual and Auditory Continuous Performance Test using the standard computerized procedure, recording attention scores according to the official test manual. Change in serum level of brain derived neurotrophic factor in patients with multiple sclerosis. Timepoint: At baseline before starting the intervention; and immediately after completion of ten intervention sessions over two weeks. Method of measurement: Measurement of serum brain derived neurotrophic factor level using enzyme linked immunosorbent assay according to the manufacturer’s instructions. Shahid Beheshti University of Medical Sciences Approved 2024-01-02 Ethics Committee of Faculty of Medicine, Shahid Beheshti University of Medical Sciences, Tehran Next to Ayatollah Taleghani Hospital, Shahid Arabi St, Yemen St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)