Brain-Computer Interface-based Programme for the Treatment of ASD/ADHD
Condition: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorders
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This project involves creating a novel and personalised BCI training system that targets
      social and communication difficulties, and inattentive symptoms problems often found in
      ASD/ADHD children. 20 participants between the age of 8 and 12 will be recruited and they
      will undergo 24 training sessions over an 8-week period. During these sessions, the children
      will play a computer game interface specifically designed to train attention and facial and
      emotional recognition, while using our BCI device. To further reinforce the treatment, the
      training system has been enhanced with the inclusion of an eye-tracker to target the lack of
      preferential eye contact that children with ASD exhibit. The investigators hypothesize that
      participants will show improvements in social skills and attention post treatment.
    

Detailed description: 
      This pilot trial aims to improve attention levels in children with comorbid ASD/ADHD. Twenty
      participants aged 8 to 12 years with comorbid ASD/ADHD will be recruited. Most therapy
      involves at least a total of 20 sessions (4); as such, the intervention protocol includes 24
      sessions followed by a follow up one month after completion. The participants will attend 24
      brain training sessions over an 8-week period, playing computer games designed for improving
      attention, facial recognition, and emotion recognition.

      Participants will be randomized to either the Intervention or Waitlist-Control study arm
      group, where the latter proceeds with training only after a wait-time of 8 weeks. The
      investigators hypothesize that participants in the Intervention group will show improved
      symptoms compared to the Waitlist-Control group at week 8. This pilot study will provide
      preliminary data to support the efficacy of the investigators new BCI-based training
      programme and potentially pave the way for a larger randomized controlled trial.

      Children with comorbid ASD/ADHD have greater impairments in attention, social skills and eye
      gaze. The investigators believe that focusing on these symptoms might lead to potentially
      better treatment outcomes. Also, current treatments for ASD/ADHD are limited in that they are
      taxing, time-consuming, and incur side effects. If the BCI-based training programme has a
      positive impact on children diagnosed with ASD and ADHD, it can potentially be an alternative
      long-term treatment. Unlike medications and behavioural interventions, neurofeedback therapy
      has no side effects and may be more engaging for children. It has the potential to be made
      available eventually for use at the patient's own home and can therefore be administered at
      one's own time and convenience.

      In 2010, the PI and his team conducted a pilot study to investigate a novel intervention for
      treatment of ADHD. The study involved subjects 7 to 12 years of age diagnosed with either
      combined or inattentive ADHD subtypes. The subjects received 20 sessions of BCI training over
      a 10-week period. The BCI training is an innovative design integrating neurofeedback system
      using an algorithm to analyze EEG brain waves, using it to drive a computer interface by
      sustaining a certain threshold of attention. Teachers of children in the intervention group
      reported larger improvements in the ADHD inattentive score although this was not
      statistically significant. Parents also fed back that the intervention was relatively safe to
      use and free of adverse effects.

      In 2012, the team completed another study that improved upon the technology and investigated
      the feasibility of the new training programme (with a simpler headset using two dry lead
      sensors instead of an EEG cap) on 20 unmedicated ADHD children participants. The treatment
      intervention was intensified to 24 sessions over 8 weeks followed by 3 monthly booster
      training sessions. An additional component was added to the training module where
      participants were required to complete a stroop task calibration process before the training.
      This is to personalise the intervention and improve accuracy of the EEG parameters. In this
      open-label trial, parents reported statistically significant improvements in both inattentive
      and hyperactive-impulsive symptoms on the ADHD Rating Scale at 8 weeks, which further
      suggests the potential efficaciousness of the novel BCI-based training programme as a
      potentially efficacious treatment for ADHD.

      In 2013, a larger-scale randomised controlled trial began to further investigate the efficacy
      of the BCI training on treating inattentive symptoms of ADHD. The randomized study aims to
      enroll 160 children between the age of 6 to 12 who will undergo 24 sessions of BCI training
      sessions over 8 weeks followed by 3 booster sessions. ADHD symptoms will be assessed
      primarily by blinded clinicians and parents as well as based on feedback obtained from
      respective school teachers. The study is currently ongoing and is estimated to complete by
      July 2016. Therapy using non-invasive BCI system-based games may represent an alternative
      treatment for children with ADHD and ASD. If demonstrated to be efficacious, parents are
      likely to prefer this as compared to current treatment modalities of medications (with
      potentially serious side effects) and behavior management (parents generally find this
      difficult and challenging). Children themselves are also more likely to enjoy the treatment
      and hence, comply better.

      In the longer term, this approach and system may have potential for attention and cognitive
      enhancement for patients with cognitive impairment or early dementia.
    

Intervention name(s): Intervention Group; Control Group
Intervention type(s): Other; Other
Intervention description(s): Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.; Participants will wait for 8 weeks before training intervention begins.
Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.
Other intervention name(s): BCI Training; Waitlist BCI Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment