Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001332415
Ethics application status
Approved
Date submitted
20/09/2016
Date registered
23/09/2016
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Date results provided
27/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
NeuroFeedback to treat young people with ADHD and Tics.
Scientific title
Neurofeedback as a non-pharmacological and non-invasive alternative to treat young patients with ADHD and co-morbid tic symptoms – A pilot study in a community setting.
Secondary ID [1] 290186 0
Nil known
Universal Trial Number (UTN)
U1111-1187-8288
Trial acronym
NFAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Deficit (ADHD) 300330 0
Tics 300331 0
Condition category
Condition code
Mental Health 300195 300195 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Current evidence suggests that the treatment of attention deficit hyperactivity disorder (ADHD) in minors should comprise a multimodal treatment approach, including stimulant medications. However, many children with ADHD also suffer from co-morbid tics, which can create significant impairments. Moreover, stimulants (which are frequently prescribed to children with ADHD) can make tics even worse. In this project we will use EEG (electroencephalography or brain wave)-based neurofeedback (NF) as a non-pharmacological approach to treat ADHD and tic symptoms in children, with the aim of avoiding stimulant medication.

During a NF session, sensors (so-called electrodes) will be placed on the subjects scalp to detect brainwaves in order to see their brain in action (this is a so-called electroencephalography or EEG). These signals are presented to the subject in real time on a computer screen. This will be done by presenting a correlate of this brain activity and not by showing the real brain waves outlined before. Your subject will have the task to up or down regulate brain activity that is related to attentional processes, motor activity and concentration. A computer compares their real-time brain activity to targets or goals for them to reach (that means to successfully up or down regulate). Images on a computer screen can tell them immediately when their brain reaches their goal and when not - when they are activating or deactivating the mentioned brain activity. 

Through this simple method, the subject can learn how to quiet brainwaves associated with low attentional performance, and increase brainwaves associated with better attentional and cognitive control. Very much like physical exercises strengthen and develop specific muscles, the more your brain is exercised into reaching a more efficient way of working, the better and stronger it gets at it. Like any new skill, it requires feedback and practice.

There will be three sequential phases to the study. The first phase will consist of a week for pre-assessment of exclusion criteria and related symptomatology (urine drug test, behavioural / psychological assessments, cognitive testing battery). EEG-based neurofeedback will be administered in the second phase to participants (N = 10 subjects) over two weeks within daily one-hour sessions on weekdays (5 sessions per week, 10 sessions per subject). If possible, each participant will be allocated a regular daily training time with the same neurofeedback trainer. Phase three will involve completion of the post-assessments (behavioural / psychological assessments, cognitive testing battery) over a week period.

The NF intervention will be delivered by researchers that have undergone a recognised NF training course. All NF trainers have university degrees.

The subject will have a participant diary card that will provide a record of all study appointments / commitments which will help encourage compliance.
Intervention code [1] 295942 0
Behaviour
Intervention code [2] 295969 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299680 0
Changes in cognitive / attentional performance (ADHD Conners 3rd Edition Scale; Cantab ADHD battery) at baseline and post neurofeedback intervention.
Timepoint [1] 299680 0
In the week following the 2 week intervention.
Primary outcome [2] 299696 0
Changes in tics (Global Tic Severity Scale) at baseline and post neurofeedback intervention.
Timepoint [2] 299696 0
In the week following the 2 week intervention.
Secondary outcome [1] 327821 0
Changes in the Child Behaviour Checklist (CBCL) at baseline and post neurofeedback intervention.
Timepoint [1] 327821 0
In the week following the 2 week neurofeedback intervention.

Eligibility
Key inclusion criteria
Confirmed diagnosis of ADHD and with co-morbid tics / Tourette’s syndrome (ICD-10 /DSM-V).
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Organic psychiatric syndromes
2. Psychotic disorders
3. Current or recent abuse of alcohol and current or recent abuse of illicit substances or dependence (recent = within the past 12 months).
4. Epilepsy
5. History of severe migraine
6. Acute medical illness that could interfere with study participation
7. Treatment with psychotropic medication

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Parametric / non-parametric statistical comparisons (i.e. such as pre / post-intervention / follow-up comparisons) will be conducted, and to quantify the efficacy of the proposed intervention strategy within this pilot sample. Although the present study involves a small number of patients (as it needs to be completed with the funds provided as well as in the 14-month timeline), the data obtained can be used to calculate sample sizes for future large- scale research, and can serve as pilot data for future grant applications (NHMRC, NIMH, ARC, DFG, etc.).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/09/2016
Date of last participant enrolment
Anticipated
25/09/2016
Actual
2/03/2017
Date of last data collection
Anticipated
7/10/2016
Actual
23/03/2017
Sample size
Target
10
Accrual to date
Final
4
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 294547 0
Charities/Societies/Foundations
Name [1] 294547 0
Telethon Kids Institute (TKI)
Country [1] 294547 0
Australia
Funding source category [2] 294548 0
Charities/Societies/Foundations
Name [2] 294548 0
Princess Margaret Hospital Foundation (PMHF)
Country [2] 294548 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
Roberts Rd, Subiaco WA 6008.
Country
Australia
Secondary sponsor category [1] 293418 0
None
Name [1] 293418 0
Address [1] 293418 0
Country [1] 293418 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295986 0
Princess Margaret Hospital Ethics Committee
Ethics committee address [1] 295986 0
Ethics committee country [1] 295986 0
Australia
Date submitted for ethics approval [1] 295986 0
05/02/2016
Approval date [1] 295986 0
31/05/2016
Ethics approval number [1] 295986 0
2016021EP

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

Contacts
Principal investigator
Name 69150 0
Prof Florian Zepf
Address 69150 0
Princess Margaret Hospital
Roberts Road, Subiaco
WA 6008
Country 69150 0
Australia
Phone 69150 0
+61 8 9340 8222
Fax 69150 0
Email 69150 0
[email protected]
Contact person for public queries
Name 69151 0
Richard Stewart
Address 69151 0
Bentley Health Service
PO Box 158
Bentley WA 6982
Country 69151 0
Australia
Phone 69151 0
+61 8 9416 3800
Fax 69151 0
Email 69151 0
[email protected]
Contact person for scientific queries
Name 69152 0
Zepf
Address 69152 0
Princess Margaret Hospital
Roberts Road, Subiaco
WA 6008
Country 69152 0
Australia
Phone 69152 0
+61 8 9340 8222
Fax 69152 0
Email 69152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data was collected for exclusive use for the study only.


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.