PR Newswire
- Evaluating safety and efficacy of Novostim 2 wearable device as key step towards future submission to FDA for marketing authorization
- Patients can enroll at UTHealth in Houston Texas , and soon at Mayo Clinic in Minnesota , Boston Children's Hospital, and Houston based Baylor College of Medicine and Texas Children's Hospital.
- To learn more visit Inno-sphere.com/clinical-solution
BERLIN , May 2, 2024 /PRNewswire/ - 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).
2016 data from the Centers for Disease Control and Prevention estimates 6 million children had been given diagnoses of ADHD and 62 percent were taking medication, often stimulants. Studies show these treatments can come with challenging side effects in children and adolescents like appetite challenges, increase in aggression, headaches, and gastrointestinal issues.
"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.
"Pharmaceuticals and specifically stimulants have been the standard of care in ADHD for decades, with challenging side effects well documented," says Rami Shacour, co-Founder and CEO of Innosphere. "Building on our previous successful clinical trial , we are ecstatic to provide a non-medicated option for children in need and look forward to a swift and impactful trial."
Patients can find out if they are eligible at this link .
About Innosphere
Innosphere (Tech Innosphere Engineering Ltd.) is delivering long-term ADHD relief through neurotechnology. The company's revolutionary, patented wearable Novostim system aims to give parents a medication-free option for pediatric ADHD treatment and make kids excited about their treatment, backed by collaborative research conducted with leading worldwide institutes and universities in the field of cognitive neuroscience.
Learn more at inno-sphere.com
Forward Looking Statements
This press release contains forward-looking statements regarding Innosphere Engineering Ltd. (the "Company") and its clinical trial for the Novostim 2 wearable device, aimed at treating pediatric ADHD through transcranial Random Noise Stimulation (tRNS). These forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. While existing research using this technology suggests the medical device to have an excellent safety profile and minimal side effects, there may be risks which will be fully explained during the informed consent process.
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SOURCE Innosphere Engineering Ltd
