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IRCT20211220053459N3 IRCT 2025-09-26 Semnan University of Medical Sciences The Effectiveness of Comorbid Transcranial Direct Current Stimulation and Upper Limb Occupational Therapy in People with Multiple Sclerosis The Effectiveness of Comorbid Transcranial Direct Current Stimulation and Upper Limb Occupational Therapy on Occupational Performance and Fine Motor Movement in People with Multiple Sclerosis: A Randomized Controlled Trial 2025-09-23 anticipated 40 Complete https://irct.ir/trial/85942 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be divided into two groups of intervention and control by Stratified Balanced Block Randomization with an equal block method. Out of a maximum of 20 modes for the six blocks, three will be in the intervention group or A, and three in the control group will be created using the RANDBETWEEN (1,20) command in Excel software. Participants will be divided equally into two groups according to the random sequence created, Blinding description: In this study, blinding will be implemented as follows: Participants: Individuals enrolled in the study will remain unaware of their assignment to either the intervention or control group. It should be noted that prior to enrollment, all participants will receive the necessary information within the framework of informed consent; however, the specific details of the intervention they will receive will not be disclosed. Outcome assessors: Those responsible for data collection and evaluation of the primary outcomes will be blinded to group allocation in order to minimize the risk of bias in recording and analyzing data. Other members of the research team (including the principal investigator and study staff) will be aware of group allocation due to the nature of the intervention; however, every effort will be made to ensure that this knowledge does not influence the conduct of the study or the interpretation of its results. N/A Multiple sclerosis. Intervention 1: Intervention group: In this study, the therapeutic intervention will consist of anodal transcranial direct current stimulation (tDCS) combined with specialized upper limb occupational therapy exercises. The aim of this combined intervention is to improve work performance and fine motor skills in patients with multiple sclerosis.Transcranial direct current stimulation (tDCS) (25)During each session, transcranial direct current stimulation will be performed using a validated tDCS device. The current intensity in this intervention will be 2 mA and the duration will be 20 min. The anodal electrode will be placed over the left primary motor cortex (area C3 in the international 10–20 EEG system) and the cathodal electrode over the right frontopolar region (area Fp2). Stimulation will be delivered with gradual ramp-up and ramp-down to minimize burning sensation. Upper limb occupational therapy exercises (27). Concurrently, participants undergo 30 minutes of specialized occupational therapy. These exercises consist of three categories of activities: Fundamental motor exercises (e.g., finger opening and closing, wrist and finger flexion/extension, forearm rotation)Fine motor exercises (e.g., bead picking, play dough, coin picking, buttoning and unbuttoning)Functional exercises related to daily living (e.g., folding a towel, picking up a glass, writing, tapping with a finger, drawing a circle)The exercises are based on the principles of Activity-Based Rehabilitation and are selected as meaningful exercises to help promote the individual’s participation in daily life (28). The intensity and level of the exercises are adjusted and modified by a trained occupational therapist according to the participant’s ability level. Intervention The above interventions are delivered in the form of 10 in-person therapy sessions over 2 weeks (5 sessions per week). Each session consists of 20 minutes of tDCS and 30 minutes of occupational therapy exercises. Intervention 2: Control group: In the control group, the device is turned on for only a short time (30 seconds) and then turned off, without the participant or the assessor being aware of the type of stimulation (double-blind).Upper limb occupational therapy exercises (27)Concurrently, participants undergo 30 minutes of specialized occupational therapy exercises. These exercises consist of three categories of activities:Fundamental motor exercises (e.g., finger opening and closing, wrist and finger flexion/extension, forearm rotation)Targeted fine motor exercises (e.g., bead picking, play with play dough, coin grasping and moving, buttoning and unbuttoning)Functional exercises related to daily living (e.g., folding a towel, picking up a glass, writing, tapping with a finger, drawing a circle)The exercises are based on the principles of Activity-Based Rehabilitation and are selected as meaningful exercises to help promote the individual’s participation in daily life (28). The intensity and level of exercises are adjusted and modified by a trained occupational therapist according to the participant’s ability level.Intervention ScheduleThe above interventions are delivered in the form of 10 in-person therapy sessions over 2 weeks (5 sessions per week). Each session consists of 20 minutes of tDCS and 30 minutes of occupational therapy exercises. Yes - There is a plan to make this available What will be shared: . When: . To whom: . Conditions: . Where to obtain: . How to obtain: . Comments:
public Fatemeh Motaharinezhad
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
Semnan Iran (Islamic Republic of) 3514617121 +98 912 453 1870 fatemeh.motahari@semums.ac.ir Semnan University of Medical Sciences scientific Fatemeh Motaharinezhad
Famili Rehabilitation Clinic, Ayatollah Madani Blvd, Famili St., Semnan, Iran
Semnan Iran (Islamic Republic of) 3514617121 +98 912 453 1870 motahari201227@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of multiple sclerosis according to the McDonald criteria Age between 18 and 65 years Right-handedness Score between 2 and 5 on the Expanded Disability Status Scale (EDSS) No similar treatments in the past three months Presence of impairment in fine hand movements Score higher than 22 on the Mini-Memory Cognitive Assessment (MMSE) 18 years 65 years Both Presence of other neurological diseases or severe cognitive impairment Pregnancy Having metal devices (such as pacemakers) that interfere with TDCS Uncooperative in performing exercises G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: In this study, the therapeutic intervention will consist of anodal transcranial direct current stimulation (tDCS) combined with specialized upper limb occupational therapy exercises. The aim of this combined intervention is to improve work performance and fine motor skills in patients with multiple sclerosis.Transcranial direct current stimulation (tDCS) (25)During each session, transcranial direct current stimulation will be performed using a validated tDCS device. The current intensity in this intervention will be 2 mA and the duration will be 20 min. The anodal electrode will be placed over the left primary motor cortex (area C3 in the international 10–20 EEG system) and the cathodal electrode over the right frontopolar region (area Fp2). Stimulation will be delivered with gradual ramp-up and ramp-down to minimize burning sensation. Upper limb occupational therapy exercises (27). Concurrently, participants undergo 30 minutes of specialized occupational therapy. These exercises consist of three categories of activities: Fundamental motor exercises (e.g., finger opening and closing, wrist and finger flexion/extension, forearm rotation)Fine motor exercises (e.g., bead picking, play dough, coin picking, buttoning and unbuttoning)Functional exercises related to daily living (e.g., folding a towel, picking up a glass, writing, tapping with a finger, drawing a circle)The exercises are based on the principles of Activity-Based Rehabilitation and are selected as meaningful exercises to help promote the individual’s participation in daily life (28). The intensity and level of the exercises are adjusted and modified by a trained occupational therapist according to the participant’s ability level. Intervention The above interventions are delivered in the form of 10 in-person therapy sessions over 2 weeks (5 sessions per week). Each session consists of 20 minutes of tDCS and 30 minutes of occupational therapy exercises. Control group: In the control group, the device is turned on for only a short time (30 seconds) and then turned off, without the participant or the assessor being aware of the type of stimulation (double-blind).Upper limb occupational therapy exercises (27)Concurrently, participants undergo 30 minutes of specialized occupational therapy exercises. These exercises consist of three categories of activities:Fundamental motor exercises (e.g., finger opening and closing, wrist and finger flexion/extension, forearm rotation)Targeted fine motor exercises (e.g., bead picking, play with play dough, coin grasping and moving, buttoning and unbuttoning)Functional exercises related to daily living (e.g., folding a towel, picking up a glass, writing, tapping with a finger, drawing a circle)The exercises are based on the principles of Activity-Based Rehabilitation and are selected as meaningful exercises to help promote the individual’s participation in daily life (28). The intensity and level of exercises are adjusted and modified by a trained occupational therapist according to the participant’s ability level.Intervention ScheduleThe above interventions are delivered in the form of 10 in-person therapy sessions over 2 weeks (5 sessions per week). Each session consists of 20 minutes of tDCS and 30 minutes of occupational therapy exercises. Occupational performance. Timepoint: Before, after and one month after the intervention. Method of measurement: Canadian Occupational Performance Measurement. Hand Function. Timepoint: Before, after and one month after the intervention. Method of measurement: The Jebsen-Taylor Manual Function Test. Hand skill. Timepoint: Before, after and one month after the intervention. Method of measurement: Nine-hole peg test. Semnan University of Medical Sciences Approved 2025-07-21 Ethics Committee of Semnan University of Medical Sciences Headquarter of Semnan University of Medical Sciences and Health Services, Bassij Blvd, Semnan, Iran. Semnan Semnan Iran (Islamic Republic of)