Protocol summary
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Study aim
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the comparative effect of unilateral and bilateral anodal tDCS electrical brain stimulation of the brain's motor area with a current intensity of 1 mA on motor learning of healthy elderly people.
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Design
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A randomized and parallel-group clinical trial study on 54 patients. The randomization is simple, which was done in a block method with the help of a random table of numbers.
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Settings and conduct
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The following study has been conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences, with the voluntary participation of healthy young elderly people. It involves 3 groups, each required to complete a movement task using the Color Matching Test (CMT) software. The first group receives unilateral anodal tDCS. the second group receives bilateral tDCS in the M1 region. The third group receives a sham tDCS. The reaction times are recorded for all participants, before the application, immediately after the application, and 72 hours post-application of the current.
The participants and the evaluator are blinded to ensure objective and unbiased results.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: healthy young elderlies (60-75 years), right-handed, willing to participate after studying the conditions.
Exclusion criteria: history of neurological/psychological diseases, forgetfulness/depression symptoms, recent CNS exposure to currents in two weeks, pacemaker use, electrical stimulation contraindications.
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Intervention groups
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Group 1: anodal tDCS unilaterally for 20 minutes with an intensity of 1 milliamp.
Group 2: bilateral tDCS with the same duration and intensity as the first group.
Group 3 (Sham tDCS): random electrode placement. The current will be cut off after a certain period and the electrodes will remain without current on the respective areas for 20 minutes.
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Main outcome variables
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reaction time; Number of errors
General information
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Reason for update
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This update is intended to clarify and correct the description of the study blinding procedures. The term “double-blind” was used in the original registration; however, during the actual conduct of the study, participants, outcome assessors, and the data analyst were blinded to group allocation, whereas the researcher responsible for administering transcranial direct current stimulation (tDCS) was aware of the assigned intervention because the device had to be configured according to the allocated treatment. Therefore, this amendment is intended to describe the blinding procedures more accurately and align the trial registration with the methods actually implemented. It does not reflect a change in the study procedures.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240312061271N1
Registration date:
2024-04-02, 1403/01/14
Registration timing:
prospective
Last update:
2026-10-11, 1405/07/19
Update count:
1
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Registration date
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2024-04-02, 1403/01/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2024-04-20, 1403/02/01
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Expected recruitment end date
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2024-07-21, 1403/04/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults
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Public title
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comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Healthy young elderly people with an age range of 60-75 years.
The dominant hand of the participants should be the right hand.
Willingness to participate in the study and sign the informed consent form.
Exclusion criteria:
Reporting any history of neurological diseases such as Parkinson's, Alzheimer's, schizophrenia and dyslexia in such a way that the disease has affected the person's ability to learn.
Report any history of psychological illness
Report exposure to currents affecting the central nervous system during the last two weeks
Report on the use of any type of sedative medication during the last two days
Report any symptoms of forgetfulness and depression
Memory disorders with a score of less than 21 through the MMSE test
The presence of any symptoms of movement disorders in the upper limb of the right hand, which, according to the researcher's evaluation and diagnosis, has caused movement restrictions in the joints of the upper limb.
Observing any symptoms of radiculopathy and carpal tunnel syndrome in the right hand with the researcher's diagnosis
Report uncorrected vision and hearing impairments
Report dizziness
Pacemaker users
Contraindications to the use of electrical stimulation
Inability to understand or follow the study process
Reluctance to participate in the study
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Age
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From 60 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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For this study, a simple and easily accessible sampling method will be used. Individuals will be divided into three groups completely at random. To ensure randomization, the block method will be used along with random tables to select numbers between 1 and 6. A treatment allocation list will then be created based on each number. Boxes will be numbered in a random sequence and each box will contain either the desired intervention or a sheet with random allocation written on it. These boxes will be completely sealed and given to the administrator and researcher based on the order of arrival of the patients. Using the aforementioned items, the standard intervention and treatment group for each person will be determined.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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To minimize bias in the study, all treatment steps will be performed by the main researcher, while the evaluation steps before and after the intervention will be carried out by a research assistant who is a physiotherapist. Participants in each group will not be informed about the treatment of the other group, and the evaluator will not be aware of which group each participant belongs to.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2024-03-12, 1402/12/22
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Ethics committee reference number
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IR.SEMUMS.REC.1402.314
Health conditions studied
1
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Description of health condition studied
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Motor learning of the healthy young elderly
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Number of errors
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Timepoint
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Before, immediately after, and 72 hours post tDCS application
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Method of measurement
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Color matching test software
2
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Description
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Reaction time
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Timepoint
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Before, immediately after, and 72 hours post tDCS application
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Method of measurement
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Color matching test software
Intervention groups
1
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Description
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The first intervention group: receiving unilateral anodal tDCS. The active anode electrode is placed on the left M1 area of the brain (C3) and the cathode electrode is placed on the right side of the forehead area for 20 minutes with an intensity of 1 mA.
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Category
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Treatment - Devices
2
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Description
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The second intervention group: received bilateral tDCS. The anode electrode is placed on the left M1 area, and the cathode electrode is placed on the right M1 area for 20 minutes with an intensity of 1 mA.
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Category
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Treatment - Devices
3
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Description
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Control group: will receive a simulated electrical stimulation of the motor area of the brain, known as sham tDCS. The placement of the electrodes will be chosen randomly. The current will increase for the first 45 seconds and then remain constant for 60 seconds, before being turned off completely. Similar to the other groups, the electrodes will remain inactive for up to 20 minutes after the procedure.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Semnan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No additional information available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available