Innosphere starts non-drug ADHD trial at leading research hospitals for children

Innosphere Engineering Ltd., a medical device company specializing in non-pharmaceutical treatments for ADHD, has announced the initiation of participant recruitment for a new clinical trial. The trial aims to evaluate the safety and efficacy of the Novostim 2 wearable device, which uses transcranial Random Noise Stimulation (tRNS) to manage ADHD symptoms in children aged 7 to 12. This crucial step is expected to lead to future FDA marketing authorization.

The recruitment process will initially take place at UTHealth in Houston, Texas, with additional enrollment sites soon opening at Mayo Clinic in Minnesota, Boston Children's Hospital, and Houston-based Baylor College of Medicine and Texas Children's Hospital.

The Centers for Disease Control and Prevention reported in 2016 that approximately 6 million children had been diagnosed with ADHD, with 62% of these children on medication, typically stimulants. These medications, while effective, often come with significant side effects such as appetite issues, aggression, headaches, and gastrointestinal problems.

Dr. Cesar A. Soutullo, a prominent figure in child and adolescent psychiatry and the Director of the ADHD Outpatient Program at McGovern Medical School at UTHealth Houston, highlighted the unique approach of Novostim 2. "The device employs a non-invasive method by delivering a weak electrical signal to the brain, enhancing brain activity. It creates a sensation akin to a gentle buzzing, potentially activating regions responsible for attention by optimizing the brain's natural functions," explained Dr. Soutullo. Following promising outcomes from smaller trials, the current study aims to test the device’s efficacy, safety, and tolerability in a larger sample size, with the ultimate goal of obtaining FDA clearance.

Participants in the study will receive either the tRNS or a sham treatment for 10 days over a two-week period at a clinical setting. The entire duration of the trial is planned to be around two months. Each treatment session will last 20 minutes, during which patients' attention will be engaged through a digital game.

Commenting on the reliance on pharmaceutical interventions in ADHD treatment, Rami Shacour, co-founder and CEO of Innosphere, noted the well-documented side effects of stimulant medications. "We are thrilled to offer an alternative, non-medicated option for children in need. We anticipate a swift and significant trial based on our previous successful clinical studies," Shacour stated.

Innosphere is advancing the long-term management of ADHD through neurotechnology with the development of the Novostim system, a patented wearable device. This innovative solution aims to provide a medication-free treatment option for pediatric ADHD, making the treatment process more appealing to children. The company's technology has garnered support through collaborative research with leading global institutes and universities specializing in cognitive neuroscience.

As Innosphere embarks on this new clinical trial, participants and their families can learn more about eligibility and the study’s process. This step marks a significant move towards providing a novel ADHD treatment that could reduce reliance on traditional medications and their associated side effects.

The company acknowledges that while current research indicates a strong safety profile for the Novostim 2 device, there are inherent risks in any clinical trial. These risks will be thoroughly communicated to participants during the consent process.

Innosphere Engineering Ltd. remains committed to revolutionizing ADHD treatment through innovative neurotechnological solutions, hoping to offer long-term relief and improved quality of life for children affected by ADHD.