The effect of neuro-feedback on the concentration of the 12-18 years of old individual with autism spectrum disorder in comparison with typically developing individuals
Effect of neurofeedback on the concentration of ASD samples (12-18 years of old)
Effect of neurofeedback on the communication skills of ASD samples (12-18 years of old)
Design
a case-control, non-randomized, one-blinded study design, 20 cases in each group, with age and sex matched control samples.
Settings and conduct
32-channel 10-20 recording system for neurofeedback study, an special game displayed on a monitor for four minutes, analyzing EEG parameters and change the game specification accordingly.
Participants/Inclusion and exclusion criteria
inclusion: cases diagnosed with ASD (DSM-V criteria)
ASD in level 1 or 2 (High function cases)
exclusion: hearing loss, poor eyesight, bilingual, neurologic disorder, brain structural damaged cases
Intervention groups
Intervention group: ASD cases in 12-18 years of old range, resident of Hamadan
Control: normal developing age- and sex match samples.
Intervention: 10 session of neurofeedback according to the EEG recording and analysis
Main outcome variables
Selective attention and communication skills of children with autism spectrum
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221012056157N1
Registration date:2023-01-24, 1401/11/04
Registration timing:registered_while_recruiting
Last update:2023-01-24, 1401/11/04
Update count:0
Registration date
2023-01-24, 1401/11/04
Registrant information
Name
Sajjad Farashi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 850 1055
Email address
farashi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuro-feedback on the concentration of the 12-18 years of old individual with autism spectrum disorder in comparison with typically developing individuals
Public title
Neurofeedback effect on 12-18 years of old ASD samples
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Autism spectrum disorder subjects diagnosed with DSM-V criteria
Without neurological disorders
Age range of 12-18
Family satisfaction
Exclusion criteria:
Hearing loss, poor eyesight, Bilingual
Neurological disorder such as schizophrenia, epilepsy, Brain tumor
Age
From 12 years old to 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
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
دانشگاه علوم پزشکی همدان (کمیته اخلاق در پژوهش)
Street address
Shahih Fahmideh Street
City
Hamadan
Province
Hamadan
Postal code
6517838736
Approval date
2022-03-22, 1401/01/02
Ethics committee reference number
IR.UMSHA.REC.1401.036
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorders
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
concentration
Timepoint
Before neurofeedback intervention, After 10 session neurofeedback intervention
Method of measurement
EEG analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: ASD samples in 12-18 years of old range
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Autism spectrum disorder research center, Hamadan University of Medical Sciences
Full name of responsible person
Sajjad Farashi
Street address
Shahid Fahmideh Street, Hamadan university of medical sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 850 1055
Email
sajjad_farashi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Vice chancellor for research and technology, Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Street, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 850 1055
Email
sajjad_farashi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Sajjad Farashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 850 1055
Email
sajjad_farashi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajjad Farashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 850 1055
Email
sajjad_farashi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Sajjad Farashi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Fahmideh street, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 918 850 1055
Email
sajjad_farashi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Most of participants were disagree with data sharing statement.
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
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The EEG data and demographical data can be shared, provided that the data be deidentified.
When the data will become available and for how long
After the study is completed and the research questions were answered, data will be deposited in data sharing repositories.
To whom data/document is available
Everyone
Under which criteria data/document could be used
Citation to the original work
From where data/document is obtainable
for example, Figshare
What processes are involved for a request to access data/document