NeuroSigma, a leading medical technology company, has recently received clearance from the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System as a treatment for pediatric Attention Deficit Hyperactivity Disorder (ADHD). This groundbreaking development offers new hope for children and adolescents struggling with ADHD, providing a non-drug alternative that is safe and effective.
ADHD is a neurodevelopmental disorder that affects millions of children worldwide. It is characterized by symptoms such as inattention, hyperactivity, and impulsivity, which can significantly impact a child’s academic performance, social interactions, and overall quality of life. While medication has traditionally been the primary treatment option for ADHD, it is not without its limitations and potential side effects.
The Monarch eTNS System represents a significant advancement in the field of ADHD treatment. It is a non-invasive device that delivers mild electrical pulses to the trigeminal nerve, which is located near the surface of the forehead. These pulses then travel to specific areas of the brain involved in ADHD symptoms, helping to regulate neural activity and improve attention and impulse control.
The first-generation Monarch eTNS System was approved by the FDA in 2019 for the treatment of pediatric ADHD. However, NeuroSigma’s second-generation device offers several enhancements that further improve its usability and effectiveness. The new system features a more streamlined design, making it easier to use and more comfortable for patients. It also includes advanced software algorithms that optimize the delivery of electrical pulses, ensuring precise targeting of the brain regions involved in ADHD.
One of the key advantages of the Monarch eTNS System is its safety profile. Unlike medication, which can have various side effects ranging from appetite suppression to sleep disturbances, the eTNS system has demonstrated minimal adverse effects. Clinical trials have shown that the most common side effects are mild and transient, including skin irritation at the site of electrode placement and headache. This makes it an attractive option for parents who are concerned about the potential risks associated with medication.
The FDA clearance for the second-generation Monarch eTNS System is based on robust clinical evidence. NeuroSigma conducted a randomized, double-blind, sham-controlled study involving 62 children aged 8 to 12 years with moderate to severe ADHD. The results showed that those who received active treatment with the eTNS system experienced significant improvement in ADHD symptoms compared to those who received sham treatment. The study also demonstrated that the benefits of eTNS treatment were sustained over a 4-week period.
The availability of a non-drug treatment option for pediatric ADHD is a significant development in the field of child psychiatry. Many parents and healthcare professionals have expressed concerns about the long-term effects of medication on children’s developing brains. The Monarch eTNS System offers a safe and effective alternative that can be used as a standalone treatment or in combination with other therapies.
NeuroSigma’s second-generation Monarch eTNS System has the potential to revolutionize the way ADHD is managed in children and adolescents. Its non-invasive nature, minimal side effects, and proven efficacy make it an attractive option for families seeking alternative treatments. As more healthcare providers become aware of this innovative technology, it is expected to become an integral part of the comprehensive care approach for pediatric ADHD.
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- Source: Plato Data Intelligence.
- Source Link: https://platohealth.ai/neurosigma-announces-fda-clearance-of-its-second-generation-monarch-etns-system-for-treating-pediatric-adhd-biospace/
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