A digital treatment for attention deficit hyperactivity disorder (ADHD) has become the first of its kind to receive CE Class IIa certification (medium/low risk) to address a mental health condition. Thanks to this the device will be available under prescription and medical supervision.
According to the company Sincrolab, which developed the system, “this treatment is aimed at improve children’s cognitive and behavioral functionsadolescents and adults wiht ADHD, combining the power of artificial intelligence with an engaging and stimulating video game experience. “The digital medical device aims to offer a non-pharmacological, effective and evidence-based solution for people who need to improve impulsiveness control and ability to concentrate.”
“There are improvements in symptoms and abilities”
As detailed in 20 minutes the CEO of Sincrolab and neurologist Ignacio de Ramón, the device is composed “a digital processing platform designed for mental health and neurorehabilitation. Through our patented artificial intelligence, practitioners can prescribe a series of activities and tasks meticulously tailored to each patient’s needs.”
In the specific treatment for ADHD,he specifies,”children complete a personalized combination of approximately 200 gamified tasks that enhance their attention and executive functions. After four months of this interactive journey, patients show notable improvements in symptoms and in the cognitive abilities that had previously eluded them.
This process requires the supervision of a doctor: “Professional supervision is the beacon that guides the patient, ensuring that the treatment is followed correctly and that every step taken is firm and safe. Our treatment does not present serious potential risks, therefore it is classified as a safe medical device; but the effectiveness of the treatment depends on the patient’s adherence.”
“As for contraindications,” he says, “The only exception is patients with epilepsydue to the use of screens in treatment. Outside of this particular case, there are no restrictions, opening the door to a wide range of people who can benefit from our platform.”
“A convenient option”
Furthermore, he adds, “the professional interprets progressanalyzing the results that our platform reports. “This monitoring allows us to quickly identify those who benefit most from treatment and adjust the course when necessary, ensuring that every effort leads to real and lasting improvement.”
For the neurologist, the main advantages of the system lie in “its accessibility, efficiency and objectivity. This platform guarantees daily and recurring access to care. Currently, approximately 70% of patients with ADHD do not receive adequate treatment that combines therapy and pharmacology. Only 30% receive only drugs and 20% receive no treatment.”
“Customary combined care can cost up to 4,000 euros a year, without being covered by insurance or social security,” he continues. “The Sincrolab offers a convenient alternative which combines effectiveness and objectivity,supported by statistical data on evolution and effectiveness.
“Controlling impulsiveness is essential”
De Ramón describes in detail some of the results achieved by the video game: “We observed a 45% improvement in impulsiveness control in patients who use Sincrolab in general. “In patients with ADHD, the percentage of improvement exceeds 15% in just 3 months of treatment.”
“Control of impulsivity is critical for these patients,” he continues. “These findings come from real-world data, outside of laboratories and clinical trials. Families who complete the treatment regimen share with us how their children organize their homework better, improve academically or receive praise from their teachers”
He adds: “I’m a combination of palpable changes day by day and objective data that show us the effectiveness of our interventions.
“The horizon of ADHD is full of possibilities”
“Our certified ADHD treatment is designed for children ages 7 to 12, but our mission goes beyond that. We also offer personalized treatments for those who face non-specific difficulties, problems with learning, attention or executive functions,” he clarifies. “We have suitable activities to stimulate the cognitive processes that need to be strengthened.”
De Ramón believes that these types of solutions illustrate a transformation we are experiencing in the approach to ADHD consequently of the emergence of a series of new technologies. “The horizon of ADHD treatment It is designed full of possibilitieswhere technology and pharmacology are intertwined with cognitive-behavioral therapy (CBT) to offer more effective solutions”, begins the neurologist.
“Significant progress is being made in areas such as low-intensity electrical stimulation (tDCS), digital treatments based on cognitive stimulation and CBT, neurofeedback and development of digital biomarkers. “These tools will allow us to identify and predict the evolution of patients with greater precision.”
“In the field of pharmacology,” he adds, “they are creating safer drugswith fewer side effects and longer-lasting action as well as research in the field of genetics that coudl create personalized drugs.
“The big challenge here,” he believes, “is to find the perfect combination between technology, pharmacology and therapy, where the I think artificial intelligence will be key. As 2015, when we began designing our own AI, I have argued that AI would revolutionize mental health treatments, and today, nearly ten years later, I say that time has come.”
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What is CE Class IIa certification and why is it important for digital treatments for ADHD?
Interview between Time.news Editor and Ignacio de Ramón, CEO of Sincrolab
Time.news Editor: Welcome, Ignacio! It’s great to have you here. Your association, Sincrolab, has made headlines recently with your digital treatment for ADHD, which is the first of its kind to receive CE Class IIa certification. can you tell us what this certification means and its importance for people dealing with ADHD?
Ignacio de Ramón: Thank you for having me! The CE class IIa certification indicates that our digital medical device has been assessed and deemed safe and effective for addressing a mental health condition like ADHD. This certification is a notable milestone because it means that our treatment can now be prescribed and monitored under medical supervision,opening up new possibilities for patients who may not have access to traditional treatment options.
Time.news Editor: Interesting! The idea of using artificial intelligence combined with a gamified experience to treat ADHD is innovative. Can you elaborate on how this technology works to improve cognitive and behavioral functions?
Ignacio de Ramón: Absolutely. Our platform utilizes patented artificial intelligence to create a personalized treatment plan for each patient. After the initial assessment, children engage in around 200 gamified tasks that are specifically designed to enhance attention and executive functions. Over a four-month interactive journey, we’ve noted remarkable improvements in symptoms and cognitive skills that were previously challenging for them.
Time.news Editor: That’s impressive! How crucial is the role of medical supervision throughout this process?
Ignacio de Ramón: Medical supervision is vital. The doctor acts as a guide, ensuring that the treatment is followed correctly. While our device is classified as a safe medical device with minimal risks—mainly excluding patients with epilepsy due to screen use—the effectiveness hinges largely on how well patients adhere to the prescribed activities. This professional guidance not only fosters compliance but also allows us to monitor progress and make adjustments as necessary for optimal outcomes.
Time.news Editor: Speaking of accessibility, you mentioned that around 70% of ADHD patients don’t receive adequate treatment. How does your platform address this issue?
Ignacio de Ramón: That’s a crucial point. Traditional combined care can be prohibitively expensive, costing up to 4,000 euros a year—often without insurance coverage. Our platform provides an accessible alternative that blends efficiency and objectivity, allowing patients to receive effective care more conveniently. We have data supporting our treatment’s effectiveness, which can lead to better outcomes for those who have been underserved in the past.
Time.news Editor: And how do you ensure the treatment remains engaging for users, particularly for children who may struggle with attention?
Ignacio de Ramón: Engagement is at the core of our design. The gamified tasks are not only fun but also structured in a way that progressively challenges the child’s attention and cognitive skills. By combining play with therapeutic tasks, we create an engaging experience that keeps patients motivated and involved throughout their treatment journey.
Time.news Editor: That sounds like a game-changer! What kind of improvements have you seen from patients who have completed the treatment?
Ignacio de Ramón: We’ve documented notable improvements in symptoms like impulsiveness and the ability to concentrate. Parents report significant behavioral changes as well, which in turn positively impacts the child’s social interactions and academic performance. Our objective data also shows that these improvements can be statistically significant after the treatment period.
Time.news Editor: It’s incredible to see non-pharmacological treatments making strides in mental health care. Where do you see the future of digital treatments for ADHD heading?
Ignacio de Ramón: I beleive the future is shining. As awareness grows and technology advances,digital treatments will play a pivotal role in mental health care. We may see more integrations with healthcare systems, increased personalization thru AI, and perhaps even expansion into othre mental health conditions.Our aim is to lead this change and provide effective, accessible solutions for those in need.
Time.news Editor: exciting times ahead! Thank you so much, Ignacio, for sharing your insights and the impactful work being done by Sincrolab. We look forward to seeing how your treatment evolves!
Ignacio de Ramón: thank you! It’s been a pleasure discussing this vital topic with you.