Trials recruiting subjects at UCLA and Seattle Children’s Hospital in the United States, and at King’s College London and the University of Southampton in the United Kingdom

Trials sponsored by the National Institutes of Mental Health (NIMH) in the U.S. and National Institute for Health Research (NIHR) in the UK

Combined trials seeking to enroll up to 375 children and adolescents with ADHD

LOS ANGELES, Nov. 08, 2022 (GLOBE NEWSWIRE) -- NeuroSigma, Inc., a Los Angeles-based bioelectronics company commercializing external trigeminal nerve stimulation (eTNS) technology for treating neurological and neuropsychiatric disorders, today announced that enrollment has commenced in two large, multicenter double-blind trials of eTNS for pediatric attention-deficit/hyperactivity disorder (ADHD).

The first trial, known as ADHD-GEMS and sponsored by the National Institutes of Mental Health (NIMH), is being conducted at UCLA and Seattle Children’s Hospital. Up to 225 children will be enrolled in a 4-week double-blinded phase followed by up to 1-year of open label follow-up.

The second trial, known as the ATTENS project, is sponsored by the UK’s National Institute for Health Research and is being conducted at King’s College London and the University of Southampton. This trial will enroll up 150 children and adolescents with ADHD for a 4-week blinded period and will obtain fMRI data in approximately 50 subjects to better understand the underlying eTNS mechanism of action.

“The start of enrollment in these two trials marks a major milestone for NeuroSigma and for advancing alternatives to medications to treat ADHD,” said Ian Cook, M.D., NeuroSigma’s Chief Medical Officer. “The data generated will significantly expand the evidence base for eTNS as a treatment for pediatric ADHD and, we believe, demonstrate the value of eTNS as a non-pharmaceutical alternative for treating this common condition. We are also excited to examine the fMRI neuroimaging data, which will enable us to demonstrate eTNS’ mechanism of action and the physiology of response."

"We are proud to support our world-class academic sponsors during the conduct of these important clinical trials,” added Colin Kealey, M.D., President and Chief Executive Officer of NeuroSigma. “The trials will produce a robust data set encompassing both children and adolescents with ADHD, as well as use of the device as an adjunctive therapy for patients already on medication. We believe this will set the stage for expanding our label into the adolescent and adjunctive populations, thereby adding tremendous value to the company.”

For Patients and Caregivers Interested in the Trials
If you are interested in learning more about how you or your loved ones can participate in these trials, please visit the websites below:
UCLA & Seattle Children’s Hospital
King’s College and University of Southampton

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.

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

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/

About the University of California Los Angeles, Semel Institute for Neuroscience and Human Behavior

The University of California Los Angeles is ranked the #1 public university by the US News and World Report for its sixth consecutive year. UCLA attracted record support for its wide-ranging research in the 2020–21 fiscal year, receiving $1.7 billion in research funding and now ranks sixth among all universities in total research expenditures. The largest funding agency is the National Institutes of Health, which awarded nearly $565 million to researchers in areas including AIDS, cancer, neurosciences, cardiovascular diseases, COVID-19 and mental health. Nearly $754 million, more than half of the total, was directed to the David Geffen School of Medicine at UCLA. This figure represents a record for the school and is $140 million higher than 2019. In addition, The Jane and Terry Semel Institute for Neuroscience and Human Behavior at UCLA was awarded $168 million.

The Jane and Terry Semel Institute for Neuroscience and Human Behavior is an interdisciplinary research and education institute devoted to the understanding of complex human behavior, including the genetic, biological, behavioral and sociocultural underpinnings of normal behavior, and the causes and consequences of neuropsychiatric disorders. In addition to conducting fundamental research, the institute faculty seeks to develop effective strategies for prevention and treatment of neurological, psychiatric and behavioral disorder, including improvement in access to mental health services and the shaping of national health policy.

Semel Institute

The Semel Institute is highly integrated with the UCLA David Geffen School of Medicine Department of Psychiatry and Resnick Neuropsychiatric Hospital; all three are devoted to research, teaching and patient care in psychiatry, neuroscience and related fields. The mission of this enterprise is threefold:

• Research — acquiring new knowledge about the factors that affect an individual’s social, psychological, intellectual and neurological health.
• Education— developing scholars and practitioners who contribute to the solution of problems related to mental health, mental retardation and diseases of the nervous system.
• Patient Care and Treatment — developing and utilizing the most effective techniques of diagnosing and treating these disorders.
  

About the UCLA and SCH Funding

This project, titled Efficacy of External Trigeminal Nerve Stimulation for Treatment of ADHD (NIH Grant Number 1R01MH126041), is funded by a NIH/NIMH (National Institutes of Health/National Institute of Mental Health) grant awarded to Principal Investigator, Dr. Sandra Loo, Professor in the UCLA Department of Psychiatry and Biobehavioral Sciences. Her Co-Principal Investigators on the project include Dr. James McGough, Professor of Clinical Psychiatry at the Semel Institute for Neuroscience and Human Behavior, and Dr. Mark Stein, Professor of Psychiatry and Behavioral Sciences at Seattle Children’s Hospital. For more information, please visit the grant’s NIH RePorter page or visit clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT05374187).

Contact:
Colin Kealey, M.D., President of NeuroSigma at CKealey@neurosigma.com