University of Surrey-backed wearable device shows promise in treating childhood ADHD with new clinical trial seeking FDA clearance

The trial uses a wearable device – Novostim 2 – developed by Innosphere Engineering Ltd. The company anticipates FDA clearance by Q3 of 2025 and has already received approval for sales in Israel.  

The novel treatment builds upon years of research into non-invasive brain stimulation techniques led by the University of Surrey's Professor Roi Cohen Kadosh. The research team carried out multiple studies in which children with ADHD were treated with transcranial Random Noise Stimulation (tRNS) coupled with cognitive training (CT).  

tRNS is a non-invasive technique that delivers a weak and painless electrical signal to the brain to enhance activity in regions associated with attention. In the studies, children who received tRNS and CT experienced significant improvements in their ADHD symptoms, working memory, and processing speed, along with changes in their brain activity, which could be linked to the improvement of their symptoms in the long-term. 

Two clinical trials have been completed using Novostim 2 at Hadassah Medical Center in children aged 7-12, which showed significant improvement in ADHD symptoms, including a 43% reduction in ADHD symptom severity and overall symptom alleviation. 

The trial, over a two-week period, involves 20-minute treatment sessions in which Novostim 2 is used to deliver tRNS over specific regions in the brain associated with ADHD and during which participants engage in attention-based digital games.  

For more information on the latest trial, visit ADHDtrial.com