Medical Device Network

Innosphere starts paediatric clinical trial for Novostim ADHD device

The Novostim 2 device uses transcranial random noise stimulation (tRNS), a non-invasive electrical stimulation, to abate symptoms of ADHD.

German device company Innosphere Engineering has started recruitment for the clinical trial for its attention deficit hyperactivity disorder (ADHD) device, Novostim 2.

The randomised, sham-controlled trial will evaluate the Novostim 2 device in children with ADHD aged 7-12 years. The data from the study will be used to seek clearance from the US Food and Drug Administration (FDA).

The Novostim treatment will be administered over 20 minutes, where patient attention will be maintained using a “digital engagement game”. The study will last for two months, and the participants will receive treatment for ten days for two weeks.

Novostim 2 is a transcranial random noise stimulation (tRNS) device. "Novostim 2 uses a non-invasive technique where a weak signal is applied to the brain, subtly enhancing brain activity,” said Dr Cesar A Soutullo, director of the ADHD Outpatient Program at McGovern Medical School, UTHealth Houston.

“It is like a buzzing sensation to the brain that may activate some regions important for attention by making your brain's natural activities change or become more efficient."

GlobalData has identified digital therapeutics as a growing sector in healthcare. The US digital therapeutics is projected to grow at a compound annual growth rate (CAGR) of 25% from 2022 to 2030. However, reimbursement of these therapies is expected to slow the adoption of these therapies, as per a GlobalData report.

Multiple companies are developing devices for relieving symptoms of ADHD. Akili has developed a digital therapeutic gaming therapy for ADHD, EndeavorRx. The therapy was approved by the FDA for improving attentional functioning in paediatric patients (aged 8-17 years) with ADHD, in 2020.

NeuroSigma is developing an external trigeminal nerve stimulation (eTNS) system, Monarch, to treat paediatric ADHD. The system delivers mild electrical impulses to the trigeminal nerve, a major cranial nerve involved in various sensory functions.

It is designed to provide an alternative treatment for children aged seven to 12 who are not using prescription medications to treat their ADHD. In January 2024, NeuroSigma received approval from the FDA to start clinical trials for the device.