Protocol summary

Study aim
A Comparative Study on the Comparison of the Effectiveness of Acupuncture,excitement training , and TACS, and Methyl Fundit in the Treatment of Hyperactivity Disorder Symptoms.
Design
children will be randomly assigned to acupuncture, TACS, drugs, and excitement training. Before the intervention first of each questionnaire CSI (parent's form) CSI-4 test IVA (pre-test) is used after therapeutic intervention is carried out. After the intervention of any post-IVA comes in at the end, 30 patients pharmacological intervention (for 8 weeks) treatment protocol Ritalin: children under 30 kg the first week of morning, 1/4 tablet, noon 1/4 tablets, the second week until the eighth morning, 1/2 tablet, noon 1/2 tablets, 30 kg of the first week of morning, 1/4 tablet noon 1/4 tablets, the second week of the third morning, 1/2 tablet, noon 1/2 tablets, week, quarter to eight in the morning a tablet, noon a tablet, 0 3 interventional therapy ear acupuncture (8 weeks, every day two times, each time for each point a Minutes Medium equitability on glue ear (ear seed) on a five-point on auricle, Brain, Excitement, Prefrontal Cortex, Shen Men, and Tranquilizar given, 30 were under treatment intervention with TACS (8 weeks and weeks three days ) in the treatment of alternating current to the anode and cathode supplant. Gets colon on the anode F3 (dorsolateral frontal left) pad small cathode (dorsolateral frontal right-F4 mini pad to lack of anodes C3 iPad mini cathode C4 mini pad to hyperactivity Impulsivity use It will be. 1-Stream is set to 1 mA. 2-Rise-Fall is set to 30 seconds. 3- Frequency is set to 10 Hz for lack of attention and 13 Hz for hyperactivity-impulsivity for 10-15 minutes.), And 0 3 for therapeutic intervention. Were compared (Therapeutic Therapy Training Course included: 8 sessions and each session was trained for one and half hours.
Settings and conduct
were randomly selected from patients referred to the psychiatric clinic of children and adolescents after the diagnosis of psychiatry in children and adolescents.
Participants/Inclusion and exclusion criteria
Inclusion: children aged 12-8 years with ADHD exclusion: autism spectrum disorder-IQ<90
Intervention groups
to acupuncture, TACS, drugs, and excitement training
Main outcome variables
Use of other non-pharmacological and psychotherapy, such as acupuncture, TACS, and excitement training that have less-complicated to treat attention deficit disorder / hyperactivity. attention and concentration subscales include (Auditory Vigilance, auditory focus, auditory speed, visual vigilance, visual focus, visual speed, sustaind attention auditory and sustaind attention visual)and areas of inhibition subscales include (response control auditory prudence, response control auditory consistency, response control visual prudence, , response control visual consistency, response control visual stamina. ‏‫ ‬‬‬

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150803023478N3
Registration date: 2018-01-02, 1396/10/12
Registration timing: registered_while_recruiting

Last update: 2018-01-02, 1396/10/12
Update count: 0
Registration date
2018-01-02, 1396/10/12
Registrant information
Name
Mohammadreza Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 2001
Email address
mohammadimr@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare of Effects of emoution regulation,acupuncture.TACS with retalin on attention deficit disorder / hyperactivity
Public title
Effects of emoution regulation, acupuncture.TACS with retalin on attention deficit disorder / hyperactivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children aged 12-8 years with ADHD- IQ>90
Exclusion criteria:
autism spectrum disorder IQ<90
Age
From 8 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 4
Randomization (investigator's opinion)
Randomized
Randomization description
simple : 120 children aged 12-8 years with ADHD were randomly selected from patients referred to the psychiatric clinic of children and adolescents after the diagnosis of psychiatry in children and adolescents. This people have been randomly assigned to draw lots in four groups with code. children will be randomly assigned to acupuncture, TACS, drugs, and excitement training.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Enghelab Square,south kargar Avenue,Roozbeh Hospital, psychiatry Research center
City
Tehran
Province
Tehran
Postal code
1333715914
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4105

Health conditions studied

1

Description of health condition studied
attention deficit disorder / hyperactivity
ICD-10 code
F90.2
ICD-10 code description
Attention-deficit hyperactivity disorder, combined type

Primary outcomes

1

Description
attention, their impulsivity, and their active involvement
Timepoint
Before and after intervention
Method of measurement
questionnaire CSI (parent's form) CSI-4 test IVA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: pharmacological intervention (for 8 weeks) treatment protocol Ritalin: children under 30 kg the first week of morning, 1/4 tablet, noon 1/4 tablets, the second week until the eighth morning, 1/2 tablet, noon 1/2 tablets, 30 kg of the first week of morning, 1/4 tablet noon 1/4 tablets, the second week of the third morning, 1/2 tablet, noon 1/2 tablets, week, quarter to eight in the morning a tablet, noon a tablet
Category
Treatment - Drugs

2

Description
Intervention group: interventional therapy ear acupuncture (8 weeks, every day two times, each time for each point a Minutes Medium equitability on glue ear (ear seed) on a five-point on auricle, Brain, Excitement, Prefrontal Cortex, Shen Men, and Tranquilizar given
Category
Treatment - Other

3

Description
Intervention group: 30 were under treatment intervention with TACS (8 weeks and weeks three days ) in the treatment of alternating current to the anode and cathode supplant. Gets colon on the anode F3 (dorsolateral frontal left) pad small cathode (dorsolateral frontal right-F4 mini pad to lack of anodes C3 iPad mini cathode C4 mini pad to hyperactivity Impulsivity use It will be. 1-Stream is set to 1 mA. 2-Rise-Fall is set to 30 seconds. 3- Frequency is set to 10 Hz for lack of attention and 13 Hz for hyperactivity-impulsivity for 10-15 minutes
Category
Treatment - Other

4

Description
Intervention group: Therapeutic Therapy Training Course included: 8 sessions and each session was trained for one and half hours
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ruzbeh hospital
Full name of responsible person
Farideh farrokhzadi
Street address
Enghelab Square.South Kargar Avenue -Ruzbeh hospital
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 1959
Fax
+98 21 5542 1959
Email
PPRCT@TUMS.AC.IR

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Psychiatry and psychology research center
Full name of responsible person
Dr. mohammadreza Mohammadi
Street address
Enghelab Square - South Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 1959
Email
PPRCT@TUMS.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Psychiatry and psychology research center
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
Gorgan University of Medical Sciences
Full name of responsible person
Farideh farrokhzadi
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Neurology
Street address
Enghelab Square - South Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 1959
Email
Farokhzadi.f@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Mohammadi
Position
Professor
Latest degree
Master
Other areas of specialty/work
Psychiatrics
Street address
Enghelab Square.South Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5541 3540
Email
Mohammadimr@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ameneh ahmadi
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Enghelab Square. South Kargar Avenue
City
Tehran
Province
Tehran
Postal code
1333795914
Phone
+98 21 5542 1959
Email
Ameneh.ahmadi.1988@gmail.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
Because of the ethical issues, individual data is not identifiable.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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
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