Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001022853
Ethics application status
Not yet submitted
Date submitted
21/09/2012
Date registered
21/09/2012
Date last updated
21/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the Efficacy of Neurotherapy as a Treatment for Dyslexia.
Scientific title
A randomised controlled trial to evaluate the effect of neurotherapy on literacy skills in people with dyslexia aged 7-15 years
Secondary ID [1] 281252 0
Nil
Universal Trial Number (UTN)
U1111-1134-9425
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental Dyslexia 287485 0
Condition category
Condition code
Mental Health 287816 287816 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be randomly allocated to one of three groups - Arm 1 (Waitlist control), Arm 2 (DC-Stim) or Arm 3 (Neurofeedback). Those in the Waitlist control group will also be randomly allocated to receive Neurofeedback or DC-Stim following the wait period.

Arm 1: waitlist control group

Arm 2 - DC-Stim group. This is a non-invasive and safe method of brain stimulation, also called transcranial direct current stimulation (tDCS), involving the application of a weak electrical current (less than 2mA overall and less than 0.07 ma per sq cm) to focal areas of the cortex via surface electrodes placed on the scalp. This intervention has been shown to modulate cortical excitability (i.e., the rate of spontaneous action potential firing) in the brain region under the electrode.

Each member of this group will complete up to 20 sessions of DC-Stim therapy (up to 60 minutes per treatment session, 3 times per week) in which one or a number of the cortical regions identified as functionally abnormal during QEEG pre-assessment will be targeted. During DC-Stim treatment, which is a passive activity, the participant is kept occupied with computer based exercises.

QEEG pre-assessment identifies the spatial coordinates of the cortical locations of potential target regions based on the Montreal Neurological Institute reference brain using the LORETA software program. The final selection of region(s) for neurotherapy will be based on clinical judgment by Professor Clark and Dr Hill, drawing on their knowledge of the dyslexia literature, including its known functional anatomy based on the presentation of their QEEG mapping.

Arm 3- Neurofeedback Group. During Neurofeedback training, subjects will complete computer exercises. In preparation, sensors are placed on the scalp to detect, amplify and record brain activity identified during assessment as dysregulated. The brain regions’ electrical activity (or brainwaves) is measured by the computer software. The computer then gives positive video and audio feedback (games and imagery) when the activation level is within the desired range. The reinforcement parameters are controlled by the therapist, who monitors the corresponding real-time measures of brain activity.

Each member of this group will complete up to 20 sessions of Neurofeedback therapy (up to 60 minutes per session, 3 times per week) in which one or a number of the cortical regions identified as functionally abnormal during QEEG assessment will be targeted.

QEEG pre-assessment is able to identify the spatial coordinates of the cortical locations of potential target regions based on the Montreal Neurological Institute reference brain using the LORETA software program. The final selection of region(s) will be based on clinical judgment by Professor Clark and Dr Hill, drawing on their knowledge of the dyslexia literature, including its known functional anatomy.
Intervention code [1] 285716 0
Treatment: Devices
Comparator / control treatment
Arm 1. Waitlist Control Group - This serves the purpose of providing an untreated comparison for the active treatment groups. Participants in the Waitlist group will be required to wait seven weeks before commencing treatment
Control group
Active

Outcomes
Primary outcome [1] 288037 0
Broad Reading Ability: assessed using a selection of the Woodcock-Johnson Tests of Achievement (WJ III ACH), including Letter-Word Identification, Reading Fluency, Passage Comprehension, the York Assessment of Reading for Comprehension (Form A) Australian Edition [YARC-Australian] and Spelling as assessed by the WJ III ACH in Spelling.
Timepoint [1] 288037 0
Pre-intervention and post-intervention for all groups. Also post waitlist period for the Waitlist group.
Primary outcome [2] 288038 0
Phonological processing: assessed using the WJ III ACH subtest (Word Attack, Sound Awareness), subtest of the Differential Ability Scale Test of Word Reading Efficiency II.
Timepoint [2] 288038 0
Pre-intervention and post-intervention for all groups. Also post waitlist period for the Waitlist group.
Primary outcome [3] 288039 0
Brain functional activity measured by the electroencephalogram (EEG ) and event-related electrical potentials (ERPs).
Timepoint [3] 288039 0
Pre-intervention and post-intervention for all groups. Also post waitlist period for the Waitlist group.
Secondary outcome [1] 299326 0
Nil
Timepoint [1] 299326 0
Nil

Eligibility
Key inclusion criteria
First language – English
Discrepancy criteria – Reading ability must be significantly lower than expected based on IQ (i.e.>1 SD difference)
Age range: 7 – 15 years
Remedial reading instruction
Minimum age
7 Years
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Deficits in hearing or visual acuity
Oral language impairment
IQ < 80
Motor impairment
Personal history of neurological, psychiatric or specified psychological impairment (e.g. epilepsy, traumatic brain injury, chronic ill health)
Psychoactive medication

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)
Children and adolescents are being recruited through an email sent by the Clinical Director of SPELD SA (Specific Learning Difficulties Association of South Australia) to all adult members of SPELD, followed by information sessions.

Enrolment of participants in the study will follow the provision of written informed consent and subsequent screening relevant to inclusion/exclusion criteria.

Participants will be allocated to treatment arm using a randomly constructed sequence of arm numbers (1 to 3). This sequence will be kept under lock and key by a nominated person who will not be involved in the screening, assessment or treatment process and will ensure that it is not accessible by anyone involved in the screening, assessment or treatment process.

The nominated person will then be responsible for allocating participants to treatment arm using the following procedure.

The first enrolled participant will be allocated the first number in the sequence. Each subsequent participant will be allocated the next number in the sequence, except that when 15 of a particular number have already been allocated to previously enrolled participants, this number will be designated as exhausted and the subsequent participant allocated the next available number in the sequence not equal to an exhausted number. This procedure will continue until all anticipated 45 participants are enrolled in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A long sequence of integers in the range 1 to 3 will be created using the RANDBETWEEN function in Microsoft Excel, with the integers 1, 2 and 3 representing the three arms of the study.

RANDBETWEEN returns a random number between the smallest and largest integer specified, which will be 1 and 3 respectively.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286026 0
University
Name [1] 286026 0
Flinders University
Country [1] 286026 0
Australia
Funding source category [2] 286049 0
Commercial sector/Industry
Name [2] 286049 0
Brain Health Clinics
Country [2] 286049 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
PO Box 2100
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 284863 0
None
Name [1] 284863 0
Address [1] 284863 0
Country [1] 284863 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288075 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 288075 0
Ethics committee country [1] 288075 0
Australia
Date submitted for ethics approval [1] 288075 0
14/09/2012
Approval date [1] 288075 0
Ethics approval number [1] 288075 0
294.12 Clark

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

Contacts
Principal investigator
Name 34726 0
Address 34726 0
Country 34726 0
Phone 34726 0
Fax 34726 0
Email 34726 0
Contact person for public queries
Name 17973 0
Mrs Robbie Hill
Address 17973 0
Brain Health Clinics
PO Box 6121 Halifax St
Adelaide, SA, 5000
Country 17973 0
Australia
Phone 17973 0
+61 8 84106500
Fax 17973 0
Email 17973 0
[email protected]
Contact person for scientific queries
Name 8901 0
Professor Richard Clark
Address 8901 0
Faculty of Social and Behavioural Sciences
School of Psychology,
Flinders University
PO Box 2100
Adelaide SA 5000
Country 8901 0
Australia
Phone 8901 0
+61 8 84106500
Fax 8901 0
Email 8901 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.