Innosphere Engineering Ltd (Innosphere or the Company), a medical device company developing non-pharmaceutical treatments for ADHD, is pleased to announce the launch of recruitment for a randomized, sham-controlled, double-blind clinical trial examining the safety and effectiveness of Novostim 2 transcranial Random Noise Stimulation (tRNS) on ADHD symptoms in pediatric patients (7 – 12 years).
„Novostim 2 uses a non-invasive technique where a weak signal is applied to the brain, subtly enhancing brain activity. 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,“ says Dr. Cesar A. Soutullo, MD, PhD, Vice Chair and Chief, Child & Adolescent Psychiatry and Director of the ADHD Outpatient Program at McGovern Medical School, UTHealth Houston.
„Following positive and encouraging results from small trials, we are testing its efficacy, safety and tolerability in a larger sample eventually seeking FDA clearance.“
Subjects will undergo either tRNS or sham treatment for 10 days during a two-week period in a clinic, with the entire trial lasting around two months. Each treatment session is 20 minutes, during which their attention will be maintained using a digital engagement game.
