Brain Hero® Neurofeedback Training (With the Device Brainhero 2019, Type 201)
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The study investigates the feasibility and the effects of training at home with personalised
      neurofeedback in children with an autism spectrum diagnosis and comorbidities. The
      personalisation relies on quantitative electroencephalography recordings performed in a
      clinic, which are also used to evaluate the efficiency of the home-based training, along with
      standardized questionnaires. The active phase is expected to last roughly 6 months, during
      which children are expected to complete multiple hours of training and complete an interim
      evaluation. Whether the training's effects are long lasting is evaluated in a follow-up
      phase, 3 months after the active phase.
    

Detailed description: 
      Autism spectrum disorders (ASD) affect one in 59 children in the developed world and are
      characterised by significant impairments in social abilities and repetitive/restrictive
      behaviours. ASD are heterogeneous in nature and manifestations, and usually come in
      conjunction with other neurodevelopmental disorders, of which attention deficit hyperactivity
      disorder (ADHD), epilepsy and intellectual disability (low Intelligence Quotient; IQ) are the
      most common. Interventions to alleviate ASD are in many instances hard to quantify in terms
      of effectiveness, leading to an inability of caregivers and practitioners to assign patients
      to an appropriate treatment approach.

      Accumulating evidence highlights the utility of electroencephalography and its mathematical
      analysis, quantitative electroencephalography (qEEG), in discriminating between ASD and
      typically developing children in early infancy and throughout development. Additionally,
      previous studies show that EEG-based neurofeedback can be used to correct brain activity
      abnormalities. This approach builds on models of brain plasticity and uses operant
      conditioning of the patient's electroencephalogram (EEG) to induce brain adaptation and
      self-regulation, which further tunes cognition, emotions and behaviour. Prior scientific
      evidence suggests impaired mirror neuron activity in ASD, which connects to mu-rhythm
      abnormalities, as recorded on an EEG. Neurofeedback-mediated training of mu-rhythm power at
      C4, a EEG electrode position, in children with ASD resulted in improved social behaviour in
      previously published research. A similar approach using the company's Brain Hero®
      neurofeedback game in ASD children with or without ADHD and/or epilepsy and irrespective of
      IQ, which participated as beta testers in a previous usability study, resulted in improved
      concentration and relaxation abilities, and improved mu-rhythm at C4.

      The objective of this feasibility study is therefore to track the efficiency of home-based
      personalised Brain Hero® neurofeedback in children with ASD and comorbidities. To identify
      whether the brain activity at other electrode positions and frequencies has been influenced
      by this neurofeedback approach and to track overall normalization of qEEG parameters in
      comparison with typically developing children, the investigators propose to engage the
      patients in a longitudinal clinical study evaluating changes in whole brain activity. To this
      end, they will employ a commercially available qEEG device to record whole scalp EEGs from
      Brain Hero® users, once before beginning neurofeedback and then again once every month over
      the course of neurofeedback. These EEGs will be analyzed using Neuroguide® (Applied
      Neurosciences) and power and coherence compared with their database of typically developing
      individuals. The points and frequencies of the neurofeedback training will be individually
      adjusted to specifically correct the EEG abnormalities detected in the patient. In comparison
      with the current C4 alpha-mu training and C4 alpha-, beta- and theta-tracking using spectral
      power measurements (available now for all Brain Hero® beta users), this approach has the
      advantage that it enables treatment personalization (e.g. training other electrode points and
      power frequencies in addition to C4 alpha-mu, as well as coherence training) and a more
      thorough tracking of treatment efficiency (by evaluating changes in spectral power and
      coherences over the entire scalp). In addition, the investigators will track changes in
      behavior using the Social Responsiveness Scale (SRS) 2 and the Behaviour Rating Inventory of
      Executive Function (BRIEF), as well as with personalized interviews, which will be completed
      by primary caregivers every three months.

      Children or adolescents, male or female, aged 6-18 years, with an ASD diagnosis according to
      the DSM-5 or ICD-10, irrespective of IQ, with or without ADHD or epilepsy will be included in
      the study. Children with a diagnosis of schizophrenia, severe generalised anxiety disorder,
      major depression, or other neurological disorders, or with a medical disorder requiring
      systemic chronic medication with confounding psychoactive effects, as well as children with
      muscle spasms affecting the facial muscles and interfering with electrode measurements will
      be excluded from the study. Because of the high heterogeneity of ASD and its extremely
      frequent association with other neurodevelopmental disorders (ADHD, epilepsy, low IQ), the
      investigators expect that data from a minimum of 30 patients will be necessary. This is also
      the sample size recommended for the case in which the differences in pre- and post- values
      are not normally distributed. Because the aim of the study is beyond statistical significance
      towards biological relevance, the investigators are aiming for an average effect size similar
      to the ones reported in previous studies. Considering that this is a longitudinal study and a
      significant number of patients might drop out (dropout rate estimated at 70% in studies
      employing two groups and involving office/clinic visits for qEEGs), the investigators aim at
      recruiting a total of 100 patients.

      The study will be conducted over 9 months, of which 6 months are active training and 3 months
      are follow-up phase, since the long-term effects of the neurofeedback training are also of
      interest. A patient undergoing all training sessions and evaluations is considered to have
      successfully completed the study.

      The study will have reached its endpoint once complete data (all four time points, all qEEGs
      and all questionnaires) will be gathered from 30 patients diagnosed with an ASD, whether or
      not associated with comorbidities.
    

Intervention name(s): Personalised Neurofeedback training at home
Intervention type(s): Device
Intervention description(s): The already available Brain Hero® EEG device will be mailed to the subject's home, along with clear video instructions regarding its use (within the app), as previously established in a beta usability study with optimal results.
All game training will take place at home, while the caregivers of patients will receive instructions either online or telephonically from the investigating team. The team is also ready with tips and tricks to keep the child motivated and facilitate the flight of the game hero in the direction of interest.
Patients will be instructed to play a minimum of 20 min for four times a week, under supervision by their caregiver(s). Patients will be provided with a training plan, including all planned months of training and advanced examinations. Instructions will also be provided, verbally and written, and the investigating team will engage in video sessions or direct meetings with the parents to make sure all instructions are properly followed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment