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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

Protocol summary

Study aim
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.
Design
A randomized, double-blind, 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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
Main outcome variables
reaction time; Number of errors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240312061271N1
Registration date: 2024-04-02, 1403/01/14
Registration timing: prospective

Last update: 2024-04-02, 1403/01/14
Update count: 0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
yaghoubali shourvarzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4225 7369
Email address
shourvarziy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-07-21, 1403/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults
Public title
comparative effects of bilateral and unilateral transcranial direct current stimulation (tDCS) over the motor cortex on motor learning in healthy older adults
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 60 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
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. Thus, this study is designed as a double-blind study to ensure impartiality.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences and Health Services Headquarters, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3519618375
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.SEMUMS.REC.1402.314

Health conditions studied

1

Description of health condition studied
Motor learning of the healthy young elderly
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of errors
Timepoint
Before, immediately after, and 72 hours post tDCS application
Method of measurement
Color matching test software

2

Description
Reaction time
Timepoint
Before, immediately after, and 72 hours post tDCS application
Method of measurement
Color matching test software

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Devices

2

Description
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.
Category
Treatment - Devices

3

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Semnan University of Medical Sciences, Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Tabatabai Clinic, Quds Boulevard, Mashahir Square
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
shourvarziy@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Kokhaei
Street address
University of Medical Sciences and Health Services Headquarters, Basij Blvd., Semnan
City
Semnan
Province
Semnan
Postal code
35147999442
Phone
+98 23 3344 8998
Fax
+98 23 3344 8998
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Yaghoubali Shourvarzi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
No. 1, Sub-section 17, Quds St.
City
Semnan
Province
Semnan
Postal code
3515771979
Phone
+98 51 4225 7369
Fax
Email
shourvarziy@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
science Committee
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Tabatabai Clinic, Quds Boulevard, Mashahir Square
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
fatemehehsani59@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Kimia Alvand
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Physiotherapy
Street address
Bostan dormitory, Semnan University of Medical Sciences, 5 km from Semnan to Damghan highway, Semnan
City
Semnan
Province
Semnan
Postal code
3518793151
Phone
+98 23 3365 4195
Email
knkimia@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No additional information available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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