Evaluating the effectiveness of transcranial light therapy method on number sense, computation, visuospatial memory, phonological processing, academic progress, electrophysiological function, and brain map of children with a math learning disorder
This research intends to evaluate the effectiveness of transcranial light therapy on children with math learning disorders.
Design
A controlled, single-blind
Settings and conduct
20 students will be selected from the special centers for children with specific learning disabilities in Tabriz city based on the entry/exit criteria, using a diagnostic interview and viewing academic records.
Participants in the experimental group will undergo transcranial phototherapy intervention. On the other hand, the participants in the control group will not receive any amount of the energy density received by the experimental group by placing a metal filter on the laser radiation site.
The present research will be conducted in the Faculty of Modern Sciences and Rehabilitation of Tabriz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Eligibility criteria:
• Normal IQ
• Age range from 8 to 13 years
Criteria for not entering the study:
• History of seizures, epilepsy, or family history
• Taking medicine or special medicines affecting the nervous system
• Presence of other neuropsychological diseases
• Non-cooperation in meetings
• Absence of more than two sessions
Intervention groups
Participants in the experimental group will undergo transcranial phototherapy intervention. On the other hand, the participants in the control group will not receive any amount of the energy density received by the experimental group by placing a metal filter on the laser radiation site.
Evaluating the effectiveness of transcranial light therapy method on number sense, computation, visuospatial memory, phonological processing, academic progress, electrophysiological function, and brain map of children with a math learning disorder
Public title
Evaluating the effectiveness of transcranial light therapy method on children with a math learning disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a math learning disorder
Age range 8 to 13 years
Normal IQ
Exclusion criteria:
History of seizures, epilepsy or its family history
Taking medicine or special medicines affecting the nervous system
Presence of other neuropsychological diseases
Non-cooperation in sessions
Absence of more than two sessions
Age
From 8 years old to 13 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the participants will know whether they are in the intervention or control group. Participants in the intervention group will undergo transcranial light therapy through laser radiation. On the other hand, the participants in the control group will not receive any amount of laser by placing a metal filter on the place of laser radiation as an obstacle. More precisely, none of the participants will know whether they have been exposed to laser radiation or not.
Placebo
Used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Single or multi-digit calculations (addition, subtraction, multiplication, and division)
3
Description
Visual-spatial memory
Timepoint
Before and after the intervention
Method of measurement
Corsi Block
4
Description
Phonological processing
Timepoint
Before and after the intervention
Method of measurement
Wechsler intelligence test supplementary scale 5 (naming speed)
5
Description
Achievement
Timepoint
Before and after the intervention
Method of measurement
Educational reports of the child
6
Description
Electrophysiological function
Timepoint
Before and after the intervention
Method of measurement
Event-related potentials (ERPs)
7
Description
brain map
Timepoint
Before and after the intervention
Method of measurement
Quantitative electroencephalography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the transcranial light therapy intervention, light will be emitted by the Lumix 3 laser device, with a wavelength of 1064 nm, continuously, with a power density of 250 mW/cm2 and an energy density of 60 J/cm2. The source of light production in this projector will be light diodes. The desired wavelength will be irradiated bilaterally in the intraparietal sulcus (IPS) for 10 minutes. The number of transcranial light therapy sessions will be 1 session and the cumulative dose will be 600 mW/cm2.
Category
Treatment - Devices
2
Description
Control group: The participants in the control group will not receive any amount of the energy density received by the experimental group by placing a metal filter on the laser radiation site.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences, Faculty of Rehabilitation
Full name of responsible person
Maryam Moghadam Salimi
Street address
Faculty of Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5138837311
Phone
+98 914 224 6164
Email
leyla.rastgar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abbas Ebrahimi Kalan
Street address
Faculty of Modern Medical Sciences, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5138837311
Phone
+98 41 3554 0447
Email
leyla.rastgar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Abbas Ebrahimi Kalan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Neurosciences and Cognition, Faculty of Advanced Medical Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5138837311
Phone
+98 41 3335 5788
Email
abbasebra@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nazari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Neuroscience Iran University of Medical Sciences, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
5138837311
Phone
+98 41 3554 0447
Email
nazaripsycho@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leyla Rastgar Farajzadeh
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Neuroscience
Street address
Department of Neurosciences and Cognition, Faculty of Advanced Medical Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.
City
Tabriz
Province
East Azarbaijan
Postal code
5138837311
Phone
+98 41 3554 0447
Email
leyla.rastgar@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