Investigating the effectiveness of transcranial direct electrical stimulation cognitive functions in children with attention deficit hyperactivity disorder
Determining the effect of transcranial direct electrical stimulation on cognitive function in children with attention deficit hyperactivity disorder
Design
Clinical trial with control group with two groups only without blinding randomized on 37 patients. Randomized by a table of random numbers
Settings and conduct
This study will be conducted as a clinical trial in 22 Bahman clinic in 2023. Each of the members of the two groups will be individually pre-tested using the Swanson-Nolan and Pelham questionnaire, the audio-visual continuous assessment software (IVA-2).The method of applying stimulation in tDCS will be in such a way that the sponge pad, which is actually the covering of the electrodes, will be soaked with 3% sodium chloride and the electrodes will be placed inside it. Anode tDCS stimulation with an intensity of 2 mA for 21 minutes and in ten sessions will be performed on the experimental group. One group received standard treatment and the other group received tdcs in addition to standard treatment, and the post-test will be performed on all participants.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Children under 12 years old
3- Willingness to study
Conditions of non-entry of participants:
1- Unwillingness to participate in the study
2-Suffering from another psychiatric disorder
3- The presence of metal parts in the body
4- Seizure history
Intervention groups
This study will be conducted as a clinical trial on children with attention deficit hyperactivity disorder. One group will receive the standard treatment and one group will receive the tdcs method in addition to the standard treatment
Main outcome variables
Short term memory; Visual and spatial skills; Executive functions; Attention and concentration; Language; Awareness of time and place; Direct electrical stimulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231030059908N1
Registration date:2023-11-21, 1402/08/30
Registration timing:prospective
Last update:2023-11-21, 1402/08/30
Update count:1
Registration date
2023-11-21, 1402/08/30
Registrant information
Name
Fateme Mollazade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5523 4944
Email address
f.mollazade1159@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-01, 1402/09/10
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of transcranial direct electrical stimulation cognitive functions in children with attention deficit hyperactivity disorder
Public title
Investigation the Effect of transcranial Direct Current Stimulation (TDCS) in attention-deficit, hyperactivity disorder (ADHD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ADHD
Exclusion criteria:
Unwilling to participate in the study
Having another psychiatric disorder
The presence of metal grafts in the body
History of seizures
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
37
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is using a table of random numbers that are selected through a random number computer.
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
Disruption Committee of Mashhad Azad University of Medical Sciences
Street address
no8 after alale ave. pirouzi blv. Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Approval date
2023-07-19, 1402/04/28
Ethics committee reference number
IR.IAU.MSHD.REC.1402.045
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of Swanson-Nolan and Pelham questionnaire (SNAP_4)
Timepoint
The beginning of the study 30 days after the start of the study
Method of measurement
Swanson-Nolan and Pelham questionnaire
2
Description
Cognitive assessment
Timepoint
The first day before the start, the tenth day.
Method of measurement
IVA-2 cognitive assessment software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: receiving transcranial direct stimulation for 21 minutes in 10 sessions
Category
Treatment - Devices
2
Description
Intervention group: In addition to the standard treatment, the new treatment receives transcranial direct electrical stimulation
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
22Bahman hospital clinic
Full name of responsible person
Mansoura Mirzade
Street address
no8. alale ave. pirouzi 2/1 blv. mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 5523 4944
Email
f.mollazade1159@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
دکتر تورج زندباف
Street address
No8. alale ave. pirouzi blv. mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 3225 0041
Email
f.mollazade1159@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Psychiatrics
Street address
No. 8, Alale Ave, Pirozi Blv, Mashhad town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
005155234944
Email
F.mollazade1159@GMAIL.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mansoure Mirzade
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
No. 8, Aref street, Mashhad town.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176982756
Phone
+98 51 3848 9800
Email
mirzadeh.mansoureh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fateme Mollazade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Psychiatrics
Street address
No.8, Alaleh Ave, Pirouzi Blvd, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9193798666
Phone
+98 51 5523 4944
Fax
Email
f.mollazade1159@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