A randomized controlled trial (RCT) to explore the effect of audio-visual entrainment among psychological disorders.

BACKGROUND AND AIM: Although many mental disorders have relevant proud in neurobiological dysfunctions, most intervention approaches neglect neurophysiological features or use pharmacological intervention alone. Non-invasive Brain-Computer Interfaces (BCIs), providing natural ways of modulating mood states, can be promoted as an alternative intervention to cope with neurobiological dysfunction. METHODS: A BCI prototype was proposed to feedback a person's affective state such that a closed-loop interaction between the participant's brain responses and the musical stimuli is established. It feedbacks in real-time flickering lights matching with the individual's brain rhythms undergo to auditory stimuli. A RCT was carried out on 15 individuals of both genders (mean age = 49.27 years) with anxiety and depressive spectrum disorders randomly assigned to 2 groups (experimental vs. active control). RESULTS: Outcome measures revealed either a significant decrease in Hamilton Rating Scale for Depression (HAM-D) scores and gains in cognitive functions only for participants who undergone to the experimental treatment. Variability in HAM-D scores seems explained by the changes in beta 1, beta 2 and delta bands. Conversely, the rise in cognitive function scores appear associated with theta variations. CONCLUSIONS: Future work needs to validate the relationship proposed here between music and brain responses. Findings of the present study provided support to a range of research examining BCI brain modulation and contributes to the understanding of this technique as instruments to alternative therapies We believe that Neuro-Upper can be used as an effective new tool for investigating affective responses, and emotion regulation (www.actabiomedica.it).