Comparison of short and long term effects of neurofeedback and transcranial electrical stimulation on the visuomotor skill learning in healthy subjects
Comparison of short and long term effects of neurofeedback and transcranial electrical stimulation on the visuomotor skill learning in healthy subjects
Design
Randomized-parallel-single-blind clinical trial on 100 people. Balanced block randomization and Randomization.com are used for randomization.
Settings and conduct
The study will be conducted in the Rehabilitation Faculty of Tehran University of medical sciences. Participants will be randomly assigned to one of the intervention or control groups. After filling the forms and questionnaires and basic measurements with the help of SRTT software, they receive the intervention. Then he returns to the place and performs his exercises with SRTT software.
35 minutes later, the participants return to perform the short-term retention and transfer test, and 48 hours later, the participants return to perform the long-term retention and transfer test.
The researcher who performs the interventions is different from the researcher who collects data and performs the statistical analysis.
Participants/Inclusion and exclusion criteria
Healthy people (both sexes)/age 18-40 years
Having no history of neurological diseases, orthopedic or neurological or rheumatological injuries that limit the upper limbs.
Intervention groups
5 groups:transcranial direct current stimulation;sham transcranial direct current stimulation;neurofeedback;sham neurofeedback;passive control group
Main outcome variables
The main outcome variables in this study are normalized reaction time and normalized number of errors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221016056187N1
Registration date:2022-11-19, 1401/08/28
Registration timing:prospective
Last update:2022-11-19, 1401/08/28
Update count:0
Registration date
2022-11-19, 1401/08/28
Registrant information
Name
Sara Rezaei eshkalak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2241 8050
Email address
srh.rezaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of short and long term effects of neurofeedback and transcranial electrical stimulation on the visuomotor skill learning in healthy subjects
Public title
Comparison of effects of neurofeedback and transcranial electrical stimulation on motor learning in healthy subjects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy (both genders)
18-40 years old
Exclusion criteria:
having a history of neurological diseases such as epilepsy and convulsions, concussion and migraine
having an orthopedic or neurological or rheumatological injury that limits the upper limbs functions
Cognitive and memory disorders (24 ≤ (Mini-Mental State Exam
Uncorrected vision problems
Taking drugs affecting the central nervous system
The presence of mental illnesses such as anxiety and depression that are associated with drug use
Intense physical activity 2 hours before the test
A history of doing activities that require a lot of dexterity in the hands, such as playing the piano
pregnancy
sleep disorders
Intracranial implants or cardiac pacemakers
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are assigned to 5 groups (real and sham transcranial electrical stimulation, real and sham neurofeedback, and control group) by the sequence created through the randomization.com site and by the balanced block randomization method. The size of the blocks is 10. Also, for the purpose of allocation concealment, sealed and numbered envelopes are used, which are provided to the participants by the secretary.
Blinding (investigator's opinion)
Single blinded
Blinding description
The researcher who conducts interventions is different from the researcher who collects information and conducts statistical analysis.Therefore, the study is single-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabilitation - Tehran
Street address
Faculty of Rehabilitation of Tehran ofuniversity Medical sciences، Pich-e-Shemiran, Enghelab St,District 12
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.TUMS.FNM.REC.1401.100
Health conditions studied
1
Description of health condition studied
The effect of transcranial direct current stimulation and neurofeedback on motor learning
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Normalized reaction time
Timepoint
Before intervention/after training/35 minutes after training/48 hours after training
Method of measurement
Serial Reaction Time Task software
2
Description
The number of normalized errors
Timepoint
Before intervention/after training/35 minutes after training/48 hours after training
Method of measurement
Serial Reaction Time Task software
Secondary outcomes
1
Description
Hand fatigue
Timepoint
Beginning of the first session/End of the first session
Method of measurement
Visual Analogue Scale (VAS)
2
Description
Level of mental fatigue
Timepoint
Beginning of the first session/End of the first session
Method of measurement
Visual Analogue Scale (VAS)
Intervention groups
1
Description
Intervention group 1: transcranial direct current stimulation: To apply tdcs , the transcranial direct current device model neurostim 2 of Medina Tab Gostar Company is used. Before the participant arrives, all the tools, including electrodes, normal saline, stimulator, cable, elastic bands, and measuring tip, are checked to ensure that they are healthy and that there are no possible failures and damages. The participant sits in a chair, then the scalp is examined for any lesions. First, the electrodes are placed in a sponge soaked with normal saline and the skin of the stimulation site is cleaned with alcohol. The size of the electrodes is 5*4. An active electrode is placed on the primary motor area of the dominant side, which corresponds to C3 or C4 according to the international 10-20 system. The cathode electrode is also placed on the supraorbital area of the non-dominant hand. The electrodes are fixed on the head by two adhesive straps. A current with an intensity of 1 milliampere is applied for a period of 30 minutes with ram up for 30 seconds and ram down for 30 seconds.
Category
Rehabilitation
2
Description
Intervention group 2: sham transcranial direct current stimulation:In this group, all the conditions are the same as the real tdcs group. Only the current is cut off after 30 seconds of ramp up.
Category
Rehabilitation
3
Description
Intervention group 3: neurofeedback: Electroencephalography active electrodes are placed on the primary motor area of the dominant side, the reference electrode is placed on the mastoid and the ground electrode is placed on the right arm. Filters are applied so that only the alpha wave is recorded. First, the alpha wave is recorded for three minutes with the eyes open in the primary motor area to determine the basic value of the alpha wave. Then, since the goal of neurofeedback is to increase the excitability of the brain by reducing the alpha wave in the primary motor area. The settings are made in such a way that in seventy percent of the time the threshold that causes the games to be played is below the basic threshold. The participants then train with neurofeedback for 30 minutes by sitting facing the monitor and watching the game being played.When the wave reaches below our desired value, the game will continue, and when the wave rises above our desired value, the game will be stopped. So, the brain will be directed to our desired direction (decrease the alpha wave) with the help of positive feedback (playing the game). 6 games will be played for 5 minutes each to prevent fatigue and reduce cooperation due to boredom. After training, electroencephalography is recorded for 3 minutes with eyes open. During the session, the researcher records the time of rapid head movements or sneezing and coughing of the participants to determine its effects in electroencephalography.
Category
Rehabilitation
4
Description
Intervention group 4: sham neurofeedback:The conditions are like real neurofeedback. 3 minutes of electroencephalography are recorded before and after the exercise, but during the exercise, a pre-recorded video of another participant is shown.
Category
Rehabilitation
5
Description
Control group: passive control: The passive control group does not receive any intervention and spends 30 minutes in the laboratory without physical and mental activity in addition to the normal state and then completes the SRTT task with the same time intervals as the intervention groups.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences - School of Rehabilitation
Full name of responsible person
Roya Khanmohammadi
Street address
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
abcd@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotohi
Street address
Research and Technology Vice-Chancellor,6th floor,Central building of the University, corner of Quds St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 8163 3686
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Rezaei eshkalak
Position
Master degree student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Fax
Email
srh.rezaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Roya khanmohammadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Email
rkhanmohammadi@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Rezaei eshkalak
Position
Master degree student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation ، Pich-e-Shemiran, Enghelab St
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 5132
Fax
Email
srh.rezaei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this 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