NeuroSigma has received US Food and Drug Administration (FDA) approval for its second-generation Monarch external trigeminal nerve stimulation (eTNS) system to treat paediatric attention deficit hyperactivity disorder (ADHD).  

Monarch eTNS 2.0 works by delivering mild electrical impulses to the trigeminal nerve, a major cranial nerve involved in various sensory functions.  

The device is designed to provide an alternative treatment for children aged seven to 12 who are not using prescription medications to treat their ADHD.  

NeuroSigma is finalising enrolment of subjects in two double-blind, multicentre trials across the US and the UK in H2 2024. The trials, which commenced in November 2022, are investigating eTNS technology in paediatric and adolescent subjects with ADHD. 

The Phase I ADHD-GEMS trial (NCT05374187) will enrol 225 children between UCLA and Seattle children’s hospital in a four-week double-blinded phase followed by one year of open-label follow up. The trial is sponsored by the National Institutes of Mental Health (NIMH). 

The Phase II trial sponsored by UK’s National Institute for Health Research, named the ATTENS project, will enrol up to 150 children and adolescents at King’s College London and the University of Southampton. This study will collect functional magnetic resonance imaging (fMRI) data in up to 50 patients on the underlying mechanism of action of eTNS. 

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NeuroSigma submitted the 510(k) submission to the FDA for Monarch eTNS 2.0 in November 2023.  

According to a report on GlobalData’s Medical Intelligence Center, wearable technology is forecast to become a huge $291bn industry by 2030, with healthcare identified as a key market for wearable devices over the next three years. 

GlobalData is the parent company of Clinical Trials Arena.

In the announcement accompanying the approval, director of NeuroSigma Thomas Paschall said: “Monarch 2.0 is a scalable device platform that will facilitate rapid commercialization not just in the United States, but also in China, Singapore, Korea and ultimately throughout the world.  

“We anticipate NeuroSigma announcing additional global partnerships and continuing to build a world class dataset for ADHD and other indications, such as drug resistant epilepsy and autism spectrum disorder.”