The Food and Drug Administration (FDA) recently granted the Breakthrough Device Designation to a new tool that may help children with autism. Developed By JelikaLite, the Cognilum System is designed to reduce symptoms of moderate to severe autism spectrum disorder (ASD) in pediatric patients who are 2 to 6 years of age.
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review.
Data from a pilot study suggests that Cognilum, a wearable medical device, can significantly improve the symptoms of children living with autism. If approved, it will offer families access to a home-based, easy-to-use, and cost-effective treatment for children with autism.
Past research shows that both genetic and nongenetic factors give rise to autism. Most appear to affect crucial aspects of early brain development. Some appear to affect how brain nerve cells, or neurons, communicate with each other. Others appear to affect how entire regions of the brain communicate with each other.
Symptoms of autism consist of a broad range of conditions characterized by challenges in verbal and nonverbal skills. These include spoken language, facial expressions, expressing emotions, and repetitive body movements.
Autism symptoms put extra challenges on parents and caregivers, especially in young children when parenting is a challenge in itself. JelikaLite Corp. believes that it can provide relief to patients and families by reducing children’s autism symptoms. Children will be able to better integrate into society, have more fulfilling lives, and their caregivers can be alleviated of stress. Furthermore, both insurance companies and the government will be able to reduce spending on intervention, special education, and lifelong residential care.
The Breakthrough Device Designation for Cognilum was based on the results of a double-blind, placebo-controlled clinical trial of 30 pediatric patients with moderate to severe autism. The trial demonstrated both the safety and efficacy of this technology. By combining non-invasive brain stimulation with near-infrared light, EEG sensors, and AI personalization platform, Cognilum demonstrated improvements in autism symptoms through gains in communication and daily living skills.
Dr. Eugenia Steingold is the Chief Science Officer of JelikaLite. “For some of the participants in our active condition, the positive change was so dramatic that their parents expressed their desire to continue the treatment even after the study was over,” she says in a statement. “We recognize that autism is a spectrum, and no two children are alike; our ultimate goal is to develop a personalized approach to every child based on their unique needs and challenges.”
JelikaLite’s vision is to bring Cognilum into the homes of families raising children with autism around the globe. This device is truly unique as it seeks to offer personalized treatment for each child with an integrated feedback loop for both caregivers and doctors.
Article written by Rhonda Errabelli
