A clinical trial to evaluate the safety and efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to improve cognitive flexibility and emotional self-regulation in young people with autism spectrum disorder

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ASD is characterized by: i) social deficits and ii) repetitive and restrictive patterns of behaviours and interests (RRPBIs). RRPBIs has been less researched in the scientific literature than the more salient social deficits. However, RRPBIs lead to severe impairments in cognitive flexibility skills and daily functioning. Some of the characteristics of RRPBIs include inflexible routines (e.g., not eating food that is coloured green or going outside without a favourite pair of shoes), rigid adherence to rules, resistance to change, obsessions, and difficulties adapting to new social contexts. Additionally, people with ASD showing highly rigid behaviour and thinking may persevere obsessively in a conversation topic or get very upset when their routine changes (e.g., always going to the shops the same way). These problems are intimately related to failures of emotional self-regulation, which is used to control one's behaviour, particularly when experiencing intrusive thoughts and negative emotions, and is thus essential for adaptive social interactions and daily functioning. Cognitive inflexibility and impairments in emotional self-regulation may also lead to increased levels of parental stress and negative parenting styles that decreases quality of life for both children and parents. Inflexible and perseverative behaviours can be measured using reversal learning paradigms whereas emotional self-regulation is usually measured using cognitive reappraisal tasks. These two processes are widely distributed across the brain. Recent cognitive neuroscience research has revealed that a single brain region within the frontal lobe, the ventrolateral prefrontal cortex (vlPFC) is primarily responsible for monitoring cognitive flexibility and controlling negative emotions, thoughts, and behaviours. Moreover, recent evidence from brain scanning techniques demonstrate abnormal activity within the vlPFC in ASD. Thus, the vlPFC is a clear target for neurobiological treatment of cognitive inflexibility and impairments in emotional self-regulation in ASD. 20 participants between 16–30 years with ASD will be recruited. Participants will undergo 1 day of pre-testing; 4 consecutive days of 20 minutes anodal or sham HD-tDCS stimulation (depending on order of administration); half-a-day of post-testing the day after the last stimulation session; a 2-week follow-up assessment. After a 4-week washout period, participants repeat the prior process in the opposite treatment condition they commenced with (anodal or sham HD-tDCS). The is a randomised, double-blind, crossover trial that aims to (a) investigate the safety of using HD-tDCS within ASD and (b) to investigate the efficacy of using HD-tDCS to reduce impairments in cognitive flexibility and emotional self-regulation skills among individuals with ASD. We will examine a range of clinical, neuropsychological and neurophysiological features. Participants’ experience of HD-tDCS, including any side effects will be collected.

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