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Trial registered on ANZCTR


Registration number
ACTRN12614000555651
Ethics application status
Approved
Date submitted
20/05/2014
Date registered
23/05/2014
Date last updated
23/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neurofeedback Training in children with dysgraphia
Scientific title
In patients with dysgraphia, could neurofeedback Training, compared to placebo, reduce the theta/beta1 and theta/alpha1 ratios in C3 and C4 brain channels respectively?
Secondary ID [1] 284631 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysgraphia 291948 0
Condition category
Condition code
Mental Health 292298 292298 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention has been through neurofeedback training. Neurofeedback training (NFT) is a promising alternative or additional treatment without any reported harmful effects. It touches on the self-regulation of ongoing neuronal fluctuations recording by EEG in some frequency bands by an auditory or visual feedback, helping to normalize and/or self-regulate the brain activities.

Eligible participants were randomly allocated to one of two groups: experimental group and control group.

For both groups: an active scalp electrode, according to the standard 10-20 system, was placed at C3 or C4 channel with the ipsilateral reference and the contralateral ground electrodes on the earlobe. Signals were acquired at 256 Hz, converted by a 14-bit A/D convertor and band-filtered to extract the theta, beta1, and alpha1 components, among others. NFT was conducted over a period of five weeks (three times a week), with each participant receiving fifteen 40-minute training sessions, consisting of 4-6 4-min game periods.

For the experimental group the amplitude of theta (represented by size and speed of game) and beta1 and alpha1 (represented by brightness and speed of game) activities was fed back using an audio-visual online feedback loop.

We have examined theta/beta1 and theta/alpha1 ratios in 8 normal subjects to compare the experimental group ratios with normal ratios.
Intervention code [1] 289417 0
Treatment: Devices
Comparator / control treatment
Procedures has been identical to experimental group except that participants were provided with placebo treatment (a random feedback instead of EEG feedback).
Control group
Placebo

Outcomes
Primary outcome [1] 292165 0
Electroencephalography (EEG) measured during NFT sessions
Timepoint [1] 292165 0
During each NFT session
Primary outcome [2] 292166 0
Number of dictation errors measured by Dictation test
Timepoint [2] 292166 0
Pre-neurofeedback and post-neurofeedback for all groups
Secondary outcome [1] 308348 0
Colorado Learning Difficulties Questionnaire (CLDQ)
Timepoint [1] 308348 0
Pre-neurofeedback and post-neurofeedback for all groups
Secondary outcome [2] 308349 0
Conners Parents Rating Scale (CPRS)
Timepoint [2] 308349 0
Pre-neurofeedback and post-neurofeedback for all groups
Secondary outcome [3] 308350 0
EEG recording during Dictation test and analysis of signals
Timepoint [3] 308350 0
Pre-neurofeedback and post-neurofeedback for all groups
Secondary outcome [4] 308351 0
Common Handwriting Errors Questionnaire
Timepoint [4] 308351 0
Pre-neurofeedback and post-neurofeedback for all groups
Secondary outcome [5] 308352 0
Type Disorder Questionnaire
Timepoint [5] 308352 0
Pre-neurofeedback and post-neurofeedback for all groups

Eligibility
Key inclusion criteria
IQ>70,
Existence of a problem in writing (dysgraphia),
Be third grade student
Minimum age
8 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A personal or family history of mental illness,
The history of vision or hearing disorders,
Brain injury,
Neurological disorders,
Serious medical condition,
A family history of genetic disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A conversation was conducted with more than 30 school’s principal in Mashhad city in Sep 2012 to provide them with information about NFT. Principals asked to introduce third grade students who have serious problems in writing and dictation. With this procedure, 154 dysgraphic Iranian children from third grade were introduced to participate in this study out of more than 30 regular primary schools.

Then we held an information session for parents and asked them to fill out a questionnaire regarding the exclusion criteria (including a personal or family history of mental illness, the history of vision or hearing disorders, brain injury, neurological disorders, serious medical condition, or a family history of genetic disorders). By assessing the questionnaire, 69 students were deleted form list.

Afterwards, it was asked from the parents of remained 85 students to sign a consent form and express their permission for participating of their child in the examinations. We have received 64 approval forms. Then we examined the IQ by an IQ test and deleted other 13 students who got IQ score of <70.

From the 51 remained students, 31 individuals were boys and 20 individuals were girls. Our final goal was to select 6 boys and 6 girls randomly to participate them into neurofeedback training sessions. To achieve the goal, we assigned a number to each student based on the time they submit their consent form (the parents were not aware this role and had no force to submit their forms as soon as possible; there was one month deadline). Numbers were allocated regardless of gender. The first submitted form was allocated the first number in the sequence. Each subsequent participant was allocated the next number in the sequence. Then we separated the numbers of girls and boys and applied a fuzzy random programming for the sequence of numbers in each gender’s group. 12 numbers were selected by this way.

For dividing the selected 12 individuals into experimental group (group 1; 7 persons) and control group (group 2; 5 persons), we applied a fuzzy random forest classifier. Regardless of gender, the subjects were randomly divided into two groups.

The participants and parents were quite unaware which group the children placed and the information about the classification was kept secret till the end of sessions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
For dividing the selected 12 individuals into experimental group (group 1; 7 persons) and control group (group 2; 5 persons), we applied a fuzzy random forest classifier. It was a Simple randomization using a randomization table created by computer software. Regardless of gender, the subjects were randomly divided into two groups.

First group, the experimental (n = 7; 3 boys and 4 girls), received NFT treatment, and the second group, the control (n = 5; 3 boys and 2 girls), received a placebo treatment. One girl from the experimental group left the experiments after three NFT sessions as a result of sociocultural problems in its family.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
We have examined theta/beta1 and theta/alpha1 ratios in 8 normal subjects to compare the experimental group ratios with normal ratios. In the other words, in order to examine how much are the ratios close to the desired normal values, we randomly selected 8 students by using simple randomisation by coin-tossing from 20 normal students.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The main hypothesis for the project was: Does neurofeedback protocol improve dysgraphia? To analyse this question some variables were selected to analyzed including colorado learning difficulties questionnaire (CLDQ), conners parents rating scale (CPRS), dictation test (DT), EEG, QEEG, common handwriting errors questionnaire (CHEQ), and type of disorder questionnaire (TDQ).

The conditions tested: neurofeedback in experimental and control groups.

Time points: Pre intervention and Post intervention for all variables except EEG and QEEG which were tested in each sessions.

The variables examined between the intervention group and the controls using a paired t-test to check for differences between both groups. Significance level was set at p = 0.05.

We have determined a sample size of 12 based on clinic capacity and funding available. However, the selected sample size (12) has been quite reasonable in the area of neurofeedback particularly in learning disabilities; for example: Fernandez et al. study in 2003 (10 sample size), Walker and Norman study in 2006 (12 sample size), and Butlers study in 2011 (12 sample size).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/09/2012
Date of last participant enrolment
Anticipated
Actual
29/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 6062 0
Iran, Islamic Republic Of
State/province [1] 6062 0
Mashhad, Khorasan Razavi

Funding & Sponsors
Funding source category [1] 289259 0
University
Name [1] 289259 0
University of Isfahan
Country [1] 289259 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
University of Isfahan
Address
Biomedical Engineering Department, University of Isfahan, Azadi square, Daneshgah Street, Isfahan, Isfahan, Iran.
Postal Code: 81746-73441
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 287933 0
None
Name [1] 287933 0
Address [1] 287933 0
Country [1] 287933 0
Other collaborator category [1] 277958 0
Individual
Name [1] 277958 0
Mohammadreza Yazdchi
Address [1] 277958 0
Biomedical Engineering Department, University of Isfahan, Azadi square, Daneshgah Street, Isfahan, Isfahan, Iran.
Postal Code: 81746-73441
Country [1] 277958 0
Iran, Islamic Republic Of
Other collaborator category [2] 277959 0
Individual
Name [2] 277959 0
Majid Ghoshuni
Address [2] 277959 0
Department of Biomedical Engineering, Mashhad Branch, Islamic Azad University, Professor Yousefi Street, Mashhad, Khorasan Razavi, Iran.
Postal Code: 91871-47578
Country [2] 277959 0
Iran, Islamic Republic Of
Other collaborator category [3] 277960 0
Individual
Name [3] 277960 0
Peyman Hashemian
Address [3] 277960 0
Department of Psychiatry, Mashhad University of Medical Science, University Ave, Mashhad, Iran.
Postal Code: 91388-13944
Country [3] 277960 0
Iran, Islamic Republic Of
Other collaborator category [4] 277968 0
Individual
Name [4] 277968 0
Hamid Khayyam
Address [4] 277968 0
75 Pigdons Road, Waurn Ponds, Victoria 3216 Australia
Country [4] 277968 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291031 0
Ethics review board of Biomedical Engineering School at University of Isfahan
Ethics committee address [1] 291031 0
Ethics committee country [1] 291031 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 291031 0
Approval date [1] 291031 0
13/06/2012
Ethics approval number [1] 291031 0
891432
Ethics committee name [2] 291032 0
IAUM ethics review board of Biomedical Engineering Department
Ethics committee address [2] 291032 0
Ethics committee country [2] 291032 0
Iran, Islamic Republic Of
Date submitted for ethics approval [2] 291032 0
Approval date [2] 291032 0
04/07/2012
Ethics approval number [2] 291032 0
H385018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48542 0
Ms Mahboubeh ParastarFeizabadi
Address 48542 0
Biomedical Engineering Department, University of Isfahan, Daneshgah Street, Isfahan, Iran.
Postal Code: 81746-73441
Country 48542 0
Iran, Islamic Republic Of
Phone 48542 0
+61 435 306326
Fax 48542 0
Email 48542 0
mparastar7@gmail.com
Contact person for public queries
Name 48543 0
Mahboubeh ParastarFeizabadi
Address 48543 0
Biomedical Engineering Department, University of Isfahan, Daneshgah Street, Isfahan, Iran.
Postal Code: 81746-73441
Country 48543 0
Iran, Islamic Republic Of
Phone 48543 0
+61 435 306326
Fax 48543 0
Email 48543 0
mparastar7@gmail.com
Contact person for scientific queries
Name 48544 0
Mahboubeh ParastarFeizabadi
Address 48544 0
Biomedical Engineering Department, University of Isfahan, Daneshgah Street, Isfahan, Iran.
Postal Code: 81746-73441
Country 48544 0
Iran, Islamic Republic Of
Phone 48544 0
+61 435 306326
Fax 48544 0
Email 48544 0
mparastar7@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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