Combined analysis of dynamic changes of EEG signals and MRI images before and after performing bimanual exercises based on computer games in hemiparetic children.
Investigating the existence of a quantitative/qualitative relationship between the location and extent of damaged brain regions (determined by MRI) and changes in the energy of brain signals in the delta, theta, alpha, beta, and gamma bands in the frontal, central, parietal, and occipital regions of the brain before and after playing a computer game.
Design
In this non-randomized and unblinded interventional study, rehabilitation measures are performed for 5 children with hemiparetic cerebral palsy, and changes in the energy of brain signals (before and after an intervention) and the anatomical location of the brain lesion (from brain MRI) are investigated.
Settings and conduct
Children diagnosed with hemiparetic cerebral palsy are entering a study at Akbar Hospital in Mashhad. Brain MRI is performed to investigate the location of the lesion, and brain waves (EEG) are evaluated before and after interventions involving bimanual exercises based on computer games.
Participants/Inclusion and exclusion criteria
Age between 5 and 18
Hemiparetic cerebral palsy
Intervention groups
Implementation of training interventions for children aged 5 to 18 years with hemiparetic cerebral palsy. In this phase, each patient participates in a one-month program consisting of 10 training sessions, each lasting between 3 and 20 minutes. During each session, the child is required to play a game in which they try to maintain the position of an object on the display screen.
Main outcome variables
evaluation of energy changes in brain signals
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250624066242N2
Registration date:2025-11-07, 1404/08/16
Registration timing:registered_while_recruiting
Last update:2025-11-07, 1404/08/16
Update count:0
Registration date
2025-11-07, 1404/08/16
Registrant information
Name
Mehran Beiraghi Toosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3801 2469
Email address
beiraghitm@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-22, 1404/07/30
Expected recruitment end date
2026-04-19, 1405/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined analysis of dynamic changes of EEG signals and MRI images before and after performing bimanual exercises based on computer games in hemiparetic children.
Public title
Combined analysis of dynamic changes of EEG signals and MRI images
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cerebral palsy hemiparetic children with appropriate cooperation
Exclusion criteria:
Children with severe visual and hearing impairments and autism
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Mashhad University of Medical Sciences (Research Ethics Committee)
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Approval date
2025-04-15, 1404/01/26
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1404.061
Health conditions studied
1
Description of health condition studied
Cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
all hand movements
Timepoint
3 month
Method of measurement
Gross Motor Function Measure, Corsi block-tapping test, Fugl-Meyer
Secondary outcomes
1
Description
Before and after the intervention exercises, we will again record the children’s brain signals in order to assess the effectiveness of the motor-cognitive exercises performed using the device. These assessments are divided into two categories.The first category involves administering standardized working memory tests. The Corsi Block-Tapping Test will be used under the supervision of a psychologist.In the next stage, the relationship and correlation between changes in the power of brain signal frequency bands in the target regions and brain imaging data will be examined.Brain signal studies are typically analyzed in terms of oscillations within electrophysiological frequency bands, which are classified as delta (1–3 Hz), theta (4–8 Hz), alpha (8–13 Hz), beta (12–25 Hz), and gamma (35–100 Hz).
Timepoint
Each patient participates in 10 training sessions over a month, with each session lasting between 20 and 30 minutes.
Method of measurement
The correlation between changes in the power of frequency bands of the brain signal in the target areas and brain images is investigated.
Intervention groups
1
Description
Before and after the intervention exercises, we will again record the children’s brain signals to assess the effectiveness of the motor-cognitive exercises performed with the device. These assessments are divided into two categories.The first category involves administering standardized working memory tests. The Corsi Block-Tapping Test will be used under the supervision of a psychologist.In the next stage, the relationship and correlation between changes in the power of brain signal frequency bands in the target regions and brain imaging data will be examined. Brain signal studies are typically analyzed in terms of oscillations within electrophysiological frequency bands, which are categorized as delta (1–3 Hz), theta (4–8 Hz), alpha (8–13 Hz), beta (12–25 Hz), and gamma (35–100 Hz).In this study, there is no control group, and evaluations will be conducted by comparing pre- and post-intervention measurements within the same participants.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar Children's Hospital
Full name of responsible person
Hedieh Riazi
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9919991766
Phone
+98 51 3844 0350
Email
Hedieh.riazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Street, Ghoreishi Department
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3844 0350
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Research of Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hadiyeh Riyazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahmad Abad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3844 0350
Email
hedieh.riazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hadiyeh Riyazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3844 0350
Email
Hedieh.riazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hediyeh Riyazi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Ahmadabad Street
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3844 0350
Email
Hedieh.riazi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after individuals are made unidentifiable.
When the data will become available and for how long
The course starts 6 months after the results are published.
To whom data/document is available
Will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
It is permissible to use the data provided that the source is acknowledged.
From where data/document is obtainable
Dr. Hamidreza Kobravi
hamidrezakobravi@gmail.com
09153173567
What processes are involved for a request to access data/document
First, Dr. Kobravi will be contacted by email or phone, and if approved, the necessary information will be provided within one month.