Clinical Evidence

The training protocol of Mente aims to rebalance the dysfunctional EEG pattern characterized by excessive activations of Delta and Beta. Mente’s algorithm which delivers the auditory feedback was designed and implemented starting from the existing literature (see table below), where an often-used protocol for autistic individuals is to inhibit delta/theta and beta, and to increase alpha brainwaves (Kouijzer et al., 2008; Thompson, Thompson, & Reid, 2010).

Several papers review the use of neurofeedback for ASD treatment and many of them provide evidence that some of the core symptoms of autism can be improved this way (Jarusiewicz, 2002; Coben and Padolsky, 2007; Coben, 2008, 2013; Kouijzer et al., 2009; Coben and Myers, 2010; Coben et al., 2010; Sokhadze et al., 2014; Friedrich et al., 2014; Wang et al. 2016; Datko et al., 2018; Carrick et al., 2018). Structural changes in EEG towards normality were also observed after individuals underwent training to decrease slow brain wave frequency power (Scolnick, 2005; Sichel et al. 1995).

The effectiveness of Mente has been investigated in a randomized, double-blinded, sham-controlled study by Carrick and colleagues (2018) involving 34 participants diagnosed with ASD, which showed the targeted EEG pattern. The clinical study shows that Mente is effective in normalizing the EEG pattern of ASD children resulting in significant mitigation of autistic symptoms as well the promotion of pro-social behaviours, better communication, engagement and improvements in cognitive skills, as supported via a clinically validated battery of questionnaires. No problems of tolerance with Mente device or the treatment itself were highlighted in the study. No clinical adverse effects, transient or permanent, were reported during the 12-weeks treatment.

A remote monitoring program for all the users of Mente has also shown that Mente promotes the expected changes in the user’s brainwaves as captured from the EEG data. Feedback from parents reported improvements related to social skills and communication as well as more engagement at school. All the changes were reported as gradual and over time, ranging from the betterment of sleep habits and general mood to substantial improvements in verbalization, interaction (eye-contact), attention span and cognitive abilities. The qualitative feedback from the selected users highlighted no reports of negative effects as well as problems of tolerance with the training delivered by Mente.

Compliance and benefits as a wearable solution

Mente is a medical-grade system which utilizes the EEG activity to provide a home-based neurofeedback training for children with neurodevelopmental disorders. The benefit of a home-based therapy can increase the likelihood of compliance with treatment protocols as well as represent a valid complementary device to increase the effectiveness of traditional NFB therapies or other approaches because treatment can be provided daily at home—a benefit, especially to ASD patients. Treatment with Mente does not preclude other forms of treatment, such as biomedical interventions and psychopharmacological treatments.

Mente is designed as a wearable, portable and wireless EEG device which is minimizing the known limitations of using neurofeedback with ASD children. Autistic children are often averse to having wires and cables placed on their heads during neurofeedback sessions as EEG is usually collected through electrodes placed on the scalp and wet with a sticky electroconductive gel. Traditional EEG caps can also limit the patient’s movements. All this may cause discomfort to ASD patients that often do not like to be touched or constrained. Being a home-based device can also enhance the success rate of the treatment as children can experience and get familiar with the new habit in the comfort of their home and with their parents. Mente can also offer flexibility regarding sessions frequency and administration thus increasing the adherence to the therapy. This is a key aspect as it can be used whenever it might be preferable during the day and eventually the therapy can be also performed sparsely to consolidate outcomes.