Clinical Trial of NeuroSigma’s Monarch eTNS System for ADHD at King’s College London Completes Enrollment

• ATTENS (ADHD trial of external trigeminal nerve stimulation) Project, led by Professor Katya Rubia at the Institute of Psychiatry, Psychology & Neuroscience is a multicentre, double-blind, placebo-controlled randomized controlled trial investigating the effect of eTNS therapy on ADHD symptoms in children and adolescents.
• Trial now fully enrolled, with 150 subjects, ages 8 – 18, randomized 1:1 to receive either active or sham eTNS therapy, final patient visit in March of 2025.
• Data will include fMRI neuroimaging, clinical and cognitive testing, and autonomic nervous system function measurements.

LOS ANGELES, Jan. 13, 2025 (GLOBE NEWSWIRE) — NeuroSigma, Inc., a Los Angeles-based bioelectronics company, announced today that the ATTENS trial, a double-blind randomized multicenter placebo-controlled trial of NeuroSigma’s Monarch® eTNS System for treating attention-deficit/hyperactivity disorder (ADHD), has completed enrollment. The trial is being funded by an Efficacy and Mechanism Evaluation grant from the United Kingdom’s National Institute for Health and Care Research (NIHR) and the Medical Research Council (MRC) and is being led by Professor Katya Rubia of the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London (King’s).  

One-hundred fifty subjects, ages 8 – 18 with a diagnosis of ADHD, were enrolled at King’s and the University of Southampton (with Professor Samuele Cortese as the Southampton site lead) to receive four weeks of either active or sham therapy using the Monarch eTNS System. The trial’s primary endpoint is the improvement in ADHD symptoms after treatment as measured by the ADHD-RS-V scale, a clinically validated, gold standard scale commonly used in clinical trials of ADHD therapies. The study is supported by King’s Clinical Trial Unit.

“Completing enrollment in a timely manner is a significant milestone for the ATTENS project,” said Professor Rubia. “Throughout the trial, recruitment and retention of subjects has been extremely robust. We believe this speaks to the public’s interest in non-pharmaceutical ADHD treatments, for which there is an urgent unmet medical need. We look forward to publishing our data after the trial’s completion in March of 2025.”

“NeuroSigma would like to extend our gratitude to Professor Rubia, her colleagues at King’s, the University of Southampton, the NIHR, and the MRC for conducting and funding this important clinical trial,” added Colin Kealey, M.D., President and CEO of NeuroSigma. “The ATTENS trial is the largest clinical trial of the Monarch eTNS System to date.   In addition to significantly increasing the size of our clinical dataset, the ATTENS trial will provide unprecedented insight into our therapy’s mechanism of action. We look forward to the study’s completion and publication of results.   Globally, interest in NeuroSigma’s eTNS platform has never been greater, and the ATTENS trial is a critical part of building our pharmaceutical-grade data set to advance this therapy. We are thrilled to have partnered with leaders in the field at King’s and University of Southampton on this important endeavor.”

About NeuroSigma
NeuroSigma is a Los Angeles, California-based bioelectronic medical device company developing technologies to transform medical practice and patients’ lives. The company’s lead product is the Monarch eTNS System, which is the first non-drug treatment for pediatric ADHD cleared by the FDA. Pipeline indications for the Monarch eTNS System include neurodevelopmental disorders such as autism spectrum disorder (ASD), learning disabilities, and epilepsy. NeuroSigma has received Breakthrough Device Designation for the Monarch eTNS System from the FDA in drug-resistant epilepsy. For more information about NeuroSigma, please visit www.neurosigma.com. For more information on the Monarch eTNS System, please visit www.monarch-etns.com.

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

King’s College London is amongst the top 35 universities in the world and top 10 in Europe (THE World University Rankings 2023), and one of England’s oldest and most prestigious universities.

With an outstanding reputation for world-class teaching and cutting-edge research, King’s maintained its sixth position for ‘research power’ in the UK (2021 Research Excellence Framework).

King’s has more than 33,000 students (including more than 12,800 postgraduates) from some 150 countries worldwide, and some 8,500 staff. The Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s is a leading centre for mental health and neuroscience research in Europe. It produces more highly cited outputs (top 1% citations) on psychiatry and mental health than any other centre (SciVal 2021), and on this metric has risen from 16th (2014) to 4th (2021) in the world for highly cited neuroscience outputs. In the 2021 Research Excellence Framework (REF), 90% of research at the IoPPN was deemed ‘world leading’ or ‘internationally excellent’ (3* and 4*). World-leading research from the IoPPN has made, and continues to make, an impact on how we understand, prevent and treat mental illness, neurological conditions, and other conditions that affect the brain.

www.kcl.ac.uk/ioppn | Follow @KingsIoPPN on Twitter, Instagram, Facebook and LinkedIn

For more information on the trial, please visit ISRCTN – ISRCTN82129325: Effects of external trigeminal nerve stimulation in ADHD and mechanisms of action.

https://sites.google.com/view/kcl-attens/home

https://www.kcl.ac.uk/research/attens-project

www.kcl.ac.uk/ioppn @KingsIoPPN

About the Funding

NIHR and MRC

The study was funded by an NIHR and MRC 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. They 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 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/

Contact: Colin Kealey, M.D., President & CEO NeuroSigma CKealey@neurosigma.com