What are the effects of Mila
on children with Specific Learning Disorders?

This is a type of scientific study in which we evaluate the performance of a therapeutic device. A study is subject to a set of standards and constraints to ensure above all the safety of the patient. In our case, we are talking about a randomized study with a control arm, i.e. one group of children will be given Mila and the other group will be given a game that will act as a placebo.

The placebo effect has been known since antiquity [1]: it is the positive effect that can be observed after any therapeutic act, independently of the effectiveness of the act itself. For example, to treat pain, the administration of a perfectly neutral substance such as sugar or water causes an improvement. This is not due to the effect of the substance itself, but to various non-specific psycho-physiological effects induced by the treatment. This effect has been widely observed in medicine, on subjective manifestations such as nausea or pain, but also on observable clinical and biological signs [3] (blood pressure, dopamine release in the brain, etc.). What we do know is that the placebo effect is attributable, at least in part, to the care situation itself, to the context. The placebo effect thus varies according to the relationship between the doctor and the patient, or according to the patient's expectations [6]. For example, the placebo effect is greater if the treatment is known to be expensive [7]. In any case, it is a very robust effect, observed not only in patients awaiting treatment but also in healthy volunteers with no particular problem [8].

Conclusion: even if a device has no efficacy of its own, it can have a positive effect on the person, simply because of the therapeutic situation that surrounds it. For this reason, if we wish to determine the efficacy of a device, it is essential to compare its effects with those produced by a device that is known to be neutral, but which is offered in the same situation as the treatment. This neutral treatment is called a placebo, and is referred to as a controlled trial, because the 'test' group is compared with a control group that receives the placebo.

[1] Patrick Lemoine, Le mystère du placebo (1996) aux éditions Odile Jacob

[2] De la Fuente-Fernández et al(2001). Expectation and dopamine release: mechanism of the placebo effect in Parkinson's disease. Science, 293(5532), 1164-1166).

[3] Stone, D. A et al, (2005). Patient expectations in placebo‐controlled randomized clinical trials. Journal of evaluation in clinical practice, 11(1), 77-84.

[4] Espay, A. J. et al. (2015). Placebo effect of medication cost in Parkinson disease: a randomized double-blind study. Neurology, 84(8), 794-802.

[5] Rosenzweig, P. et al. (1995). The placebo effect in healthy volunteers: influence of experimental conditions on physiological parameters during phase I studies. British journal of clinical pharmacology, 39(6), 657-664.

The main objective is to examine the effect of a musical training in the form of a video game, Mila, on the reading abilities of children with specific specific learning disorders.

In order to obtain sufficient training time to observe an effect and a low risk of abandonment, the protocol will consist, for 8 weeks, of 5 training sessions per week of approximately 25 minutes each

Although the study is highly dependent on its completion by the participants, your safety will always come first and your wishes will obviously be respected if you were to discontinue your participation in the research.

Please note that the study protocol will be explained to you beforehand by a doctor and you will have a withdrawal period. A team will also be available at all times in case of technical problems or questions regarding the study.