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IRCT20221106056413N2 IRCT 2023-06-12 Shiraz University of Medical Sciences Effects of direct current stimulation on hand function. tDCS Evaluating the efficiency of transcranial direct current stimulation on hand motor function in healthy individuals. 2023-06-22 anticipated 54 Complete https://irct.ir/trial/68179 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible candidates to enter the study were assigned by random allocation using block randomization method. The recruited individuals were randomly assigned to one of the two groups of (intervention with tDCS) and a control group (sham tDCS), which will use block randomization with different block sizes. The size of the blocks will be a multiple of 2 and a divisor of 54 (2, 4, and 6). Initially, the block sizes are chosen randomly. Then for each block, different permutations are randomly determined by the Randomization Allocation Software. In each block, the number of people in the groups is equal, and blinding is used to not reveal the permutations in the last people of each block, Blinding description: A direct current stimulator (Neurostim2., Medina Teb, Iran) was used to deliver anodal tdcs in accordance with the current safety limitations with the same protocol and a stimulation intensity of 1-2 mA based on the volunteers tolerance. The volunteers will be assigned to the intervention and control groups through given numbers 0001 to 0054. Also, the placement of the electrodes, the intervention time, the session intervals, and the sensation caused by the stimulation, which is in the form of itching or burning in the stimulated area (the device will not stimulate muscle twitching), will be the same in the two intervention and control groups. In this study, the person who will perform the statistical analysis will be unaware of how the candidates are grouped. (two-way blinded). N/A Hand function. Intervention 1: Intervention group: The intervention group includes 27 people with stimulation protocol (anodal) transcranial stimulation with direct current on the non-dominant primary motor cortex in 20-minute sessions, 5 sessions, three sessions per week for volunteers. In this case, the cathode will be placed on the (M1) supraorbital area of ​​the opposite side. Each session includes 20 minutes of transcranial direct current stimulation. Immediately before the start of the first session and immediately after the fifth treatment session, the grip strength of the hand will be measured by a dynamometer, as well as the force measurement of the hand by the pegboard test as the results of the study. Intervention 2: Control group:Including 27 people, which sham protocol with a maximum current of 2 m/A that will be applied to the patient's head for 30 seconds. Electrodes on the non-dominant primary cortex will be performed in 20-minute sessions, 5 sessions, three sessions per week, and then the current will be halted. Electrodes on the non-dominant primary cortex will be done for them in three sessions a week. In this case, the cathode will be placed on the supraorbital area of ​​the opposite side. Immediately before the start of the first session and immediately after the fifth therapeutic session, the grip strength of the hand will be measured by a dynamometer, as well as the strength of the hand the hand dexterity will be measured by the purdue pegboard test as the results of the study. 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 Tayebeh Sadat Salehi Rihani
No. 2, 14th East Ave., Sabari Blvd., Aghdasieh street., Tehran
Tehran Iran (Islamic Republic of) 1956819173 0098 26452587 tayebe.sadat.s.r@gmail.com Shiraz University of Medical Sciences scientific Tayebeh Sadat Salehi Rihani
No. 2, East 14th Ave., Sabari Blvd., Aghdasieh Street., Tehran
Tehran Iran (Islamic Republic of) 1956819173 +98 21 2645 2587 tayebe.sadat.s.r@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Healthy individuals in the age range of 20-45 years 20 years 45 years Both persistent and severe migraine headaches. Chronic skin problems. presence of metal plates on the head. the use of any stimulators or implants. history of epilepsy or serious or recent head trauma. any musculoskeletal or nerve disease affecting the hand function. Rehabilitation Rehabilitation Intervention group: The intervention group includes 27 people with stimulation protocol (anodal) transcranial stimulation with direct current on the non-dominant primary motor cortex in 20-minute sessions, 5 sessions, three sessions per week for volunteers. In this case, the cathode will be placed on the (M1) supraorbital area of ​​the opposite side. Each session includes 20 minutes of transcranial direct current stimulation. Immediately before the start of the first session and immediately after the fifth treatment session, the grip strength of the hand will be measured by a dynamometer, as well as the force measurement of the hand by the pegboard test as the results of the study. Control group:Including 27 people, which sham protocol with a maximum current of 2 m/A that will be applied to the patient's head for 30 seconds. Electrodes on the non-dominant primary cortex will be performed in 20-minute sessions, 5 sessions, three sessions per week, and then the current will be halted. Electrodes on the non-dominant primary cortex will be done for them in three sessions a week. In this case, the cathode will be placed on the supraorbital area of ​​the opposite side. Immediately before the start of the first session and immediately after the fifth therapeutic session, the grip strength of the hand will be measured by a dynamometer, as well as the strength of the hand the hand dexterity will be measured by the purdue pegboard test as the results of the study. Hand grip. Timepoint: Before the intervention and at the end of the intervention. Method of measurement: dynamometer. Hand dexterity. Timepoint: Before and after the intervention. Method of measurement: Purdue Pegboard test. Shiraz University of Medical Sciences Approved 2023-06-10 Ethics committee of Shiraz University of Medical Sciences Department of Physical & Rehabilitation Medicine, Faghihi Hospital, Zand Street Tehran Tehran Iran (Islamic Republic of)