NeuroSigma Announces MHRA Approval to Commence Largest Clinical Trial of eTNS for Pediatric ADHD








NeuroSigma Announces King’s College London Team Receives MHRA Approval to Commence Largest Clinical Trial of eTNS for Pediatric ADHD to Date


Double-blind randomized controlled trial of eTNS for pediatric ADHD will enroll up to 150 participants at two sites in London and Southampton

NeuroSigma’s Monarch eTNS System and electric patches to be used in the trial


LOS ANGELES and LONDON, April 07, 2022 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a bioelectronic medical device company, today announced that a team at the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London received approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) to commence the largest trial of external Trigeminal Nerve Stimulation (eTNS) ever conducted. The clinical trial will be led by Professor Katya Rubia, a Professor of Cognitive Neuroscience at King’s IoPPN, and is funded by a £1.9 million award from a partnership between the UK’s National Institute for Health Research (NIHR) and the Medical Research Council (MRC). The multicenter trial will enroll up to 150 children with moderate to severe ADHD and randomize them to receive active or sham eTNS for a four-week blinded period. Participants’ response to treatment will be assessed via parent, and teacher rating scales, as well as cognitive tests. A subgroup of approximately 58 children will receive functional magnetic resonance imaging (fMRI) at baseline and after four weeks of therapy.


“We would like to thank Professor Rubia and her team at King’s IoPPN who led these efforts, as well as the UK’s NIHR and MRC for providing funding, and the MHRA for approval to commence enrollment,” said Dr. Colin Kealey, President of NeuroSigma. “This will be the largest clinical trial of eTNS ever conducted that will be able to test the safety and efficacy of eTNS for pediatric ADHD.”


ADHD is one of the most common neurodevelopmental disorders affecting approximately 7% of children worldwide. It is typically treated with medication, most commonly stimulants, but these often carry significant side effects and don’t work for all patients. In 2019, NeuroSigma’s Monarch eTNS System became the first-ever non-pharmaceutical treatment to receive FDA clearance as a treatment for pediatric ADHD. To deliver therapy with the Monarch, patients place an adhesive electric patch on their forehead. The patch is then connected to a handheld pulse generator that delivers a mild electrical current to the V1 division of the trigeminal nerve that is located just beneath the surface of the skin.


“I am very excited to soon start enrolling patients in this clinical trial,” commented Professor Katya Rubia. “There is a clear need for safe and effective non-drug treatments for ADHD. This will also be the first clinical trial of eTNS to use fMRI to better understand the therapy’s mechanism of action. If successful, this trial will dramatically expand the evidence base supporting use of eTNS in this patient population and also help us better understand how the therapy exerts its effect. Such data could be used to predict which patients might respond prior to initiating therapy as well as other potential indications for eTNS.”


About NeuroSigma


NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients' lives. The company is developing therapies to treat a wide spectrum of neurological and neuropsychiatric disorders, including ADHD, drug-resistant epilepsy, and depression. The company is currently commercializing the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com. For more information on the trial, please visit ISRCTN - ISRCTN82129325: Effects of external trigeminal nerve stimulation in ADHD and mechanisms of action.


About King’s College London and the Institute of Psychiatry, Psychology & Neuroscience


King's College London is one of the top 35 UK universities in the world and one of the top 10 in Europe (QS World University Rankings, 2020/21) and among the oldest in England. King's has more than 31,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and 8,500 staff. King's has an outstanding reputation for world-class teaching and cutting-edge research. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is the premier centre for mental health and related neurosciences research in Europe. It produces more highly cited outputs (top 1% citations) on mental health than any other centre (SciVal 2019) and on this metric we have risen from 16th (2014) to 4th (2019) in the world for highly cited neuroscience outputs. World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness and other conditions that affect the brain.

www.kcl.ac.uk/ioppn @KingsIoPPN


About the funding:


MRC and NIHR


The study was funded by an MRC and NIHR partnership created to support the evaluation of interventions with potential to make a step-change in the promotion of health, treatment of disease and improvement of rehabilitation or long-term care.


1. The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

  • Funding high quality, timely research that benefits the NHS, public health and social care;

  • Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;

  • Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;

  • Attracting, training and supporting the best researchers to tackle complex health and social care challenges;

  • Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;

  • Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.


2. The Medical Research Council is at the forefront of scientific discovery to improve

human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers’ money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed. Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation. https://mrc.ukri.org/

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