Protocol summary

Summary
The purpose of the present study was to investigate the efficacy of trans-cranial direct current stimulation (TDCS) application over the motor cortex compared to the cerebellum region on the implicit motor learning in the healthy individuals. This study has clinical trial design. Participants will be randomly allocated in to three groups included; Group I who received 20 minutes TDCS over the motor cortex, Group II who received 20 minutes TDCS over the cerebellum region and Group III who served as placebo group (mounted TDCS electrodes over the motor cortex and cerebellum region randomly without any TDCS currents for 2 minutes). The healthy participants with 18-35 years with right dominant hand will be included. Participants who have history of neurological diseases or musculoskeletal disorders, severe perceptual and memorial problems, brain diseases, visual and auditory problems, upper extremity pathology and range of motion limitation will be excluded. All participants will be asked to perform a serial reaction time task (SRTT) during experiment. The SRTT will be repeated for 35 minutes and then two days after applying TDCS. Decreasing reaction time of the SRTT in the first session will be considered as the online learning and in the second session as the offline learning. Accordingly, the obtained data will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015030221294N1
Registration date: 2015-05-28, 1394/03/07
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-28, 1394/03/07
Registrant information
Name
Fatemeh Ehsani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
f.ehsani@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences, Semnan, Iran
Expected recruitment start date
2015-04-01, 1394/01/12
Expected recruitment end date
2015-10-01, 1394/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of motor cortex and cerebellum regions trans cranial direct current stimulation on implicit motor learning in healthy individuals; a comparative study
Public title
The effect of motor cortex and cerebellum regions trans-cranial direct current stimulation on implicit motor learning in healthy individuals; a comparative study
Purpose
Basic scienece
Inclusion/Exclusion criteria
The main conditions of inclusion criteria: Participants (male or female) who have mean age of 18-35 years; Participants are right dominant hand. The main conditions of exclusion criteria: Participants who have a history of neurological diseases or musculoskeletal disorders; Participants with severe perceptual and memorial problems that based on mini mental status examination (MMSE) have scale less than 21; Having a history of brain diseases, especially Parkinson and Alzheimer's; Having visual and auditory problems; Having upper extremity pathology and range of motion limitations.
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitie of Semnan university of medical science
Street address
Semnan, 5 kilometer in Damghan Road
City
Semnan
Postal code
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
94/25/583

Health conditions studied

1

Description of health condition studied
Healthy individual
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Reaction time
Timepoint
Before, 35 minute and two days after intervention
Method of measurement
Color Matching Test Software

Secondary outcomes

1

Description
Error meaning
Timepoint
Before, 35 minute and two days after intervention
Method of measurement
Color Matching Test Software

Intervention groups

1

Description
Before using TDCS, the participants will be asked to do SRT task containing 2 blocks. Then, anodal and cathodal electrodes will be positioned on motor cortex and contra-lateral buccinator muscle, respectively. Stimulation will be used with 2 Mili Ampere intensity for 20 minutes. The participants concurrently will be asked to do SRT task containing 8 blocks. 35 minute and two days after test, the participants will be asked to repeat doing SRT task containing 2 blocks.
Category
Treatment - Other

2

Description
Before using TDCS, the participants will be asked to do SRT task containing 2 blocks. Then, anodal and cathodal electrodes will be positioned on cerebellum and ipsi-lateral buccinator muscle, respectively. Stimulation will be used with 2 Mili Ampere intensity for 20 minutes. The participants concurrently will be asked to do SRT task containing 8 blocks. 35 minute and two days after test, the participants will be asked to repeat doing SRT task containing 2 blocks.
Category
Other

3

Description
Before using sham TDCS, the participants will be asked to do SRT task containing 2 blocks. Then, electrodes will be positioned randomly on motor cortex and cerebellum of any participant. Stimulation will be used with 2 Mili Ampere intensity for 2 second. The participants concurrently will be asked to do SRT task containing 8 blocks. 35 minute and two days after test, the participants will be asked to repeat doing SRT task containing 2 blocks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Mashahir Square, Blvd. Ghods
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Asghary
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Blvd. Basigh, Semnan, Iran
City
Semnan
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, Semnan University of Medical Sciences
Proportion provided by this source
100
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
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Position
Ph.D. student of Physical Therapy, Faculty scholarship
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 233340867
Fax
+233 340867
Email
f.ehsani@semums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Ph.D. Student in physical Therapy, Facalty Scholarships
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 233340867
Fax
+233 340867
Email
f.ehsani@semums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Ph.D. student of Physical Therapy, Facalty Scholarships
Other areas of specialty/work
Street address
Blvd. Ghods, Mashahir Square, Semnan, Iran
City
Semnan
Postal code
Phone
+98 233340867
Fax
+233 340867
Email
f.ehsani@semums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...