Comparison the effect of transcranial direct current stimulation between unihemispheric concurrent dual site and primary motor cortex on motor learning in healthy individuals
The aim of study is to determine the effect of unihemispheric concurrent dual site transcranial direct current stimulation (tDCS) on motor learning of serial reaction time task in young healthy individuals. This clinical trial phase 2 is single center and single blind. Individuals are randomly divided to three groups; Simultaneous stimulation on primary motor and dorsolateral prefrontal cortices, stimulation on primary motor cortex and sham stimulation. Subjects are blind regarding the tDCS intervention. Sample size is 16 cases in each group with power of 80% and 95% confidence interval. In this study, individuals practice 8 blocks of serial reaction time task during 3 consecutive days.
Transcranial direct current stimulation is applied during the whole course of the motor training. Stimulation is applied on mentioned areas with 1mA current, 0.16 mA/cm2 current density for 20 minutes during 3 consecutive days.
In sham stimulation, same current is applied only for the first 30 s and in the remained time, the current is turned off without the awareness of person. Individuals do not have any disability in the upper extremity and memory problems. Every 3 days and in each 8 blocks, reaction time and number of errors are recorded. Changes of reaction time and number of errors in the last block than first block is indicative of motor learning.
General information
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT2016071028808N2
Registration date:2016-11-02, 1395/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-02, 1395/08/12
Registrant information
Name
Ailin Talimkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 1857
Email address
ai.talimkhani@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research University of Social Welfare and Rehabilitation Sciences, Investigator
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of transcranial direct current stimulation between unihemispheric concurrent dual site and primary motor cortex on motor learning in healthy individuals
Public title
The effect of transcranial direct current stimulation on motor learning
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The healthy young participants who are 18 to 35 year old; The participants who are right handed; The participants who have no history of neurological or psychiatric diseases; The participants who have no serious memory deficits; The participants who have no skin problems on the head; The participants who have no disability in upper extremity.
Exclusion criteria: Several factors that stop software; The participants who leave test for any reason; Severe fatigue.
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Method of grouping is Consecutive random assignment by block.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2015-09-21, 1394/06/30
Ethics committee reference number
IR.USWR.REC.1394.222
Health conditions studied
1
Description of health condition studied
Motor learning
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Reaction time in each block
Timepoint
3 consecutive days
Method of measurement
In millisecond and using Superlab5 software
Secondary outcomes
1
Description
Number of errors in each block
Timepoint
3 consecutive days
Method of measurement
Based on the number and using Superlab5 software
Intervention groups
1
Description
Unihemispheric concurrent dual site transcranial direct current stimulation(tDCS UCDS) of primary motor and dorsolateral prefrontal cortices، 1 milliampere current intensity, 0.16 milliampere/ square centimeter current density, 20 minutes time of stimulation, Three consecutive days
Category
Rehabilitation
2
Description
Transcranial direct current stimulation of primary motor cortex (tDCSm1), 1 milliampere current intensity, 0.16 milliampere/square centimeter current density, 20 minutes time of stimulation, Three consecutive days.
Category
Rehabilitation
3
Description
Transcranial direct current stimulation, Sham stimulation, 1 milliampere current intensity only for the first 30 s, Turned off current for remained 20 minutes time of stimulation, Three consecutive days.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Ailin Talimkhani
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Ailin Talimkhani
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences