NeuroSigma Announces New Clinical Trial of Monarch eTNS System for Treatment of ADHD in Children with Fetal Alcohol Syndrome at UCLA
By GlobeNewswire Published on April 30, 2025, 20:00 IST Trial to be conducted at UCLA and funded by a grant from National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First phase of trial will enroll up to 30 children ages 8 – 12 with exposure to alcohol during gestation to receive treatment with the Monarch
Upon successful completion of Phase I, investigators will proceed with a larger, double-blind randomized crossover trial
LOS ANGELES, April 30, 2025 (GLOBE NEWSWIRE) — NeuroSigma, Inc. , a Los Angeles-based bioelectronics company commercializing the Monarch external Trigeminal Nerve Stimulation (eTNS) device for treating ADHD , today announced a new clinical trial of the Monarch for treating symptoms of ADHD in children with fetal alcohol syndrome (FAS). The 2-year trial will be led by Professor Joseph O'Neill , Adjunct Professor of Psychiatry at UCLA, and is being funded by an initial $350,000 grant from the National Institute of Alcohol Abuse and Alcoholism (NIAAA) . Monarch devices and supplies for the trial will be provided by NeuroSigma.
Repeated exposure to alcohol during gestation is associated with a significantly increased risk of learning and behavioral problems during childhood. These children tend to develop symptoms similar to ADHD such as hyperactivity, impulsivity, and executive function deficits. Children with FAS also tend to be less responsive to conventional ADHD therapies, such as stimulant medications, which can lead to worse outcomes, and increases the need for new approaches to treating this vulnerable population.
In its first phase, the trial will enroll up to 30 children ages 8 – 12 with exposure to alcohol during gestation and exhibiting symptoms of ADHD. The children will receive nightly therapy with the Monarch for 4 weeks, and parents will keep track of their children's ADHD symptoms, sleep habits, adverse events, and tolerability of the therapy during the 4-week treatment period. The primary goal of Phase I is to demonstrate feasibility. If successful, investigators will proceed with a larger, double-blind randomized crossover trial.
'NeuroSigma is thrilled to work with leading medical professionals and scholars in the field of child psychiatry to expand the indications for our proprietary Monarch eTNS therapy. We are grateful to Professor O'Neil and his colleagues for commencing this innovative and important clinical trial,' commented Colin Kealey, M.D., President and CEO of NeuroSigma, adding, 'We would also like to thank the NIAAA for their generous grant that will support this work. According to the CDC, up to 1 in 20 school aged children may suffer from fetal alcohol spectrum disorders, and our goal is that the Monarch will provide patients, caregivers, and healthcare providers with a new option for treating this underserved population.'
Families interested in participating in the clinical trial may email the study at [email protected] , call at (310) 267-2710, or fill-out an online screener to determine eligibility .
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 include neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), learning disabilities, and 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 .
Contact:
Colin Kealey, M.D., President of NeuroSigma at [email protected]
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time Business News
2 hours ago
- Time Business News
When to Choose Strattera Over Adderall
Attention-Deficit/Hyperactivity Disorder (ADHD) affects millions of people worldwide, leading to difficulties with focus, impulsivity, and hyperactivity. While stimulant medications like Adderall are often the first line of treatment, non-stimulant options such as Strattera (atomoxetine) can be a more appropriate choice in certain situations. Understanding when to choose strattera vs adderall involves evaluating factors such as the patient's medical history, potential side effects, risk of substance abuse, and overall treatment goals. When managing depression and anxiety, selecting the appropriate medication is crucial for effective treatment. Both medications in question are popular SSRIs that help balance serotonin levels in the brain, improving mood and emotional stability. In the middle of this discussion, Lexapro vs zoloft often arises as a common comparison due to their similar uses but distinct side effect profiles and dosing schedules. While some patients respond better to one, others may experience fewer adverse effects or more rapid relief with the alternative. Consulting a healthcare provider is essential to tailor the choice to individual needs and medical history. Strattera and Adderall are both approved by the FDA for treating ADHD but function in very different ways. Adderall is a stimulant composed of amphetamine salts that work by increasing the levels of dopamine and norepinephrine in the brain. This results in improved attention, reduced impulsivity, and greater overall concentration. On the other hand, Strattera is a selective norepinephrine reuptake inhibitor (NRI), which means it primarily boosts norepinephrine without significantly impacting dopamine levels. Unlike Adderall, Strattera is not a controlled substance and carries a much lower risk of abuse. One of the primary reasons to choose Strattera over Adderall is when there's a concern about substance misuse or a history of addiction. Adderall is a Schedule II controlled substance due to its high potential for abuse and dependency. For individuals with a history of substance use disorder, Adderall may pose a serious risk. Strattera, being non-stimulant and non-addictive, offers a safer alternative. It allows for effective ADHD management without the risk of reinforcing addictive behaviors, making it particularly useful in populations vulnerable to stimulant misuse. Many individuals with ADHD also suffer from comorbid mental health conditions like anxiety or depression. In such cases, Strattera may be a better option than Adderall. Stimulants like Adderall can exacerbate anxiety symptoms in some patients, leading to increased restlessness, jitteriness, or panic attacks. Strattera, on the other hand, has shown some efficacy in improving symptoms of anxiety and may also provide mild antidepressant effects due to its norepinephrine-enhancing properties. Choosing Strattera can help manage both ADHD and accompanying mood or anxiety disorders without worsening either condition. Adderall, especially the immediate-release version, has a relatively short duration of action, requiring multiple doses throughout the day. Even the extended-release versions may wear off by late afternoon or evening. In contrast, Strattera is taken once daily and offers 24-hour symptom coverage. This can be particularly advantageous for individuals who need consistent control over their ADHD symptoms throughout the day and into the evening. Students, working professionals, or parents managing multiple responsibilities might find this steady effect preferable to the peaks and troughs associated with stimulant medications. While stimulants are effective for many people, they also come with a host of potential side effects, including insomnia, appetite suppression, irritability, increased heart rate, and elevated blood pressure. For some individuals, these side effects can be intolerable or even dangerous, particularly if they have underlying cardiovascular issues. Strattera generally has a milder side effect profile and is not associated with the same degree of appetite suppression or cardiovascular stimulation. Although it has its own set of side effects, such as nausea or fatigue, these are often more manageable and tend to lessen over time. In some clinical scenarios, a non-stimulant medication like Strattera is the preferred first-line treatment. For example, in younger children (especially those under six years of age), stimulants may not be recommended due to potential side effects and lack of data on long-term safety. Pediatricians may opt for Strattera as a gentler initial approach. Additionally, parents who are concerned about the stigma or potential long-term effects of stimulant use may feel more comfortable starting their child on a non-stimulant option. Stimulants such as Adderall can interfere with sleep, especially if taken later in the day. Sleep disturbances are a common complaint among stimulant users and can contribute to irritability, mood swings, and worsening of ADHD symptoms. Strattera is less likely to cause sleep disruption and may even help improve sleep quality for some patients. For individuals who already struggle with insomnia or erratic sleep patterns, Strattera may be the better treatment choice. One of the key differences between Adderall and Strattera is how quickly they take effect. Adderall typically produces noticeable results within hours, making it ideal for patients seeking immediate symptom relief. Strattera, however, requires several days to weeks to build up in the system and reach full therapeutic effect. For patients and clinicians willing to adopt a slower, more gradual treatment approach, this delayed onset can be worthwhile, especially given Strattera's longer-term stability and lower side effect profile. Because Adderall is a controlled substance, it comes with regulatory burdens such as limited refills, stricter prescribing rules, and potential stigma. Some patients or caregivers may prefer a treatment that does not involve these complications. Strattera, being non-controlled, can be prescribed more freely and refilled more easily. This can improve medication adherence and reduce the hassle associated with frequent doctor visits or pharmacy restrictions. In some cases, clinicians may not be completely certain whether a patient's symptoms are primarily due to ADHD or another condition such as anxiety, depression, or trauma-related disorders. Since stimulants can exacerbate certain psychiatric symptoms or produce euphoria, starting with a non-stimulant like Strattera can be a safer way to assess a patient's response without clouding the diagnostic picture. If symptoms improve with Strattera, it may confirm that norepinephrine imbalance plays a role in the condition, guiding future treatment decisions. Choosing between Strattera and Adderall requires a personalized approach that considers the individual's medical history, lifestyle, comorbid conditions, and treatment preferences. While Adderall remains highly effective for many, Strattera presents a viable and often safer alternative for those with substance abuse risks, anxiety, sleep disturbances, or cardiovascular concerns. It is also a strong option for patients seeking all-day symptom coverage or those who prefer to avoid controlled substances. Consulting with a knowledgeable healthcare provider is crucial in determining which medication best aligns with the patient's needs and long-term goals. TIME BUSINESS NEWS
Yahoo
2 hours ago
- Yahoo
Maine has fifth-highest rate of emergency department visits nationwide
Editor's Note: The following story first appeared in The Maine Monitor's free health care newsletter, Health Monitor, that is delivered to inboxes every other Thursday. Sign up for the free newsletter to stay informed of Maine health care news. Maine has the fifth-highest rate of emergency department visits in the country, which hospital officials say could get worse with cuts to Medicaid and further contraction of services. Hospitals in the state saw 555 emergency department visits per 1,000 people in 2023, according to recent data from the American Hospital Association analyzed by KFF. The only states with higher rates were West Virginia with a rate of 596 per 1,000 people, North Dakota with a rate of 591, Louisiana with a rate of 589 and Mississippi with a rate of 567. Nevada had the lowest rate of 226, followed by Alaska at 258 and Arizona at 281 visits per 1,000 residents. Steven Michaud, president of the Maine Hospital Association, said Maine has had a high rate of emergency department visits for decades, which he said is largely because it is one of the most rural states and has limited access to primary care doctors, which can drive Mainers to the emergency department if they can't get timely access to primary care. 'A lot of it is not an emergency,' he said. 'They're using it as their primary care, which you just don't want to do because it's inefficient, it's expensive and all that.' While the trend is not new, this all comes at a time when Maine hospitals are merging, reducing services and even closing. Northern Light Inland Hospital in Waterville stopped its services on May 27. A California-based nonprofit announced plans to take over three hospitals through its purchase of Central Maine Healthcare. Northern Light Health reported a $156 million loss last year. Mount Desert Island Hospital announced it would close its birthing unit in July. MaineGeneral planned to end its pediatric psychological services last month. And on May 29, two Aroostook County hospitals said they would merge their management for a year to 'remain viable.' Michaud said these are 'unprecedented times,' and that these closures are happening across the state, even in smaller communities where they don't grab as much attention. For example, he said Penobscot Valley Hospital also had to end behavioral health services due to financial losses and paused payments after lawmakers failed to initially pass the supplemental budget. All these closures may not be the primary driver of the trend of emergency visits, but they're definitely a factor, he said. 'What happens when people get into a behavioral health crisis? Where do they go? The emergency departments,' Michaud said. Hospitals have tried to address the issue by creating walk-in clinics, he said, but that requires additional staff. Dr. Jay Mullen, CEO of BlueWater Health and a practicing emergency physician with experience in hospitals around the state, agreed with Michaud that the highest use of emergency departments is in the 'most rural areas where access to primary care, dental care and urgent care services are the most limited.' He added that Maine has a higher proportion of older adults and people with chronic conditions, which can contribute to emergency department visits. High use of emergency departments can strain resources, leading to longer wait times and potentially delayed care, Mullen said. 'For patients, this can mean fragmented care and less continuity, especially when (emergency department) visits are used in place of primary care,' he said. 'However, it's important to note that (emergency departments) in Maine are doing their best to meet these needs — often serving as the only accessible point of care for vulnerable populations.' And in some communities, Mullen said there can be benefits. High rates of emergency department visits can actually be a 'financial stabilizer' for rural hospitals by providing critical revenue to support broader hospital operations. 'Rural (emergency departments) operate with high fixed costs — staffing, infrastructure, and compliance requirements remain constant regardless of patient volume,' he said. 'When visit volumes are low, these fixed costs are spread across fewer encounters, making each visit disproportionately expensive. But when volume increases, even modestly, it helps offset those fixed costs and improves the financial viability of the department.' Both Mullen and Michaud said another factor contributing to high rates of ED visits is that many Mainers have coverage from MaineCare, the state's version of Medicaid. Nearly a third of all Mainers were enrolled in MaineCare last year, including two-thirds of nursing home residents and half of all children. This isn't limited to rural areas, Mullen said. Urban areas with a lot of people on MaineCare also see higher rates of emergency department visits, suggesting 'that both geographic and socioeconomic factors are at play.' People on MaineCare often struggle to find primary care providers who will accept them due to low reimbursement rates, Michaud said. As a result, they might end up in the emergency department. Michaud said expected federal cuts to Medicaid will only make this worse: 'Any time you reduce coverage, you exacerbate this.' U.S. House Republicans narrowly forwarded a bill last week that would reduce Medicaid spending by at least $600 billion dollars over 10 years and is expected to reduce enrollment by about 10 million Americans. Another factor impacting emergency department visits is that Maine sees high numbers of visitors, many of whom don't have doctors, so hospitals in destination towns along the coast often see surges in the summer, Michaud said. While Maine's rural nature may explain its high ranking for emergency department visits per capita, there were some rural states that had low rates. In particular, Michaud said he was surprised to see Alaska among the lowest rates. And Massachusetts, which has near-universal healthcare, still had the 14th highest rate of emergency department visits. Michaud said there are many factors that contribute to these trends and it's difficult to tell what might explain each state's ranking. It might be that some states have robust public health networks, unlike Maine, which has only two city public health departments in Portland and Bangor. 'Hospitals in Maine serve as the public health infrastructure,' he said.
Yahoo
2 hours ago
- Yahoo
HCLTech Grant Americas second edition awards $1 million to three NGOs to create scalable solutions to combat climate change
NEW YORK and NOIDA, India, June 5, 2025 /CNW/ -- HCLTech (NSE: (BSE: a leading global technology company, announced Osa Conservation as the winner and Daily Acts and Ocean Wise as the two runners-up of the second edition of the HCLTech Climate Action Grant in the Americas. The three non-government organizations (NGOs) will be awarded a total of $1 million to help build scalable, sustainable solutions to drive climate action across the Americas. In the second year, applications increased by more than 70%, and after several rounds of review and rigorous due diligence, HCLTech selected Osa Conservation to receive $500,000 and Daily Acts and Ocean Wise to receive $250,000 each. This year's registrations increased by 34% from the 10 eligible countries across the Americas, including Argentina, Brazil, Canada, Colombia, Costa Rica, Guatemala, Mexico, Panama, Peru and the U.S. Osa Conservation, based in Costa Rica, will focus its grant award on Climate Lifeboat corridors, which help species migrate and thrive amid climate change. By reconnecting fragmented tropical habitats, the project supports climate adaptation while safeguarding ecosystems across millions of acres. California-based Daily Acts will use its grant for its community-powered climate resilience initiative. The project blends government strategy with grassroots action to advance water management, stormwater mitigation and social infrastructure across neighborhoods in Petaluma, Calif. and beyond. Canada-based Ocean Wise will dedicate its grant to its kelp forest restoration project on the Pacific coast. By managing urchin overpopulation and combining advanced technology and ecological research, the project aims to strengthen marine biodiversity and support coastal communities. "We are excited to support this year's recipients of the HCLTech Grant Americas as they expand their innovative projects to reconnect natural habitats, boost community resilience and rejuvenate marine ecosystems across the Americas," said Dr. Nidhi Pundhir, Senior Vice President, Global CSR, HCLTech. "This year, we saw a substantial increase in applications, highlighting the urgency of mitigating the adverse effects of climate change and the importance of supporting initiatives that pave the way for a sustainable future." In its inaugural year in 2023, HCLTech Climate Action Grant in the Americas committed $5 million in grants over five years to support sustainable solutions to fight the climate crisis across the Americas. The Grant in the Americas builds on HCLTech and the HCLFoundation (HCLTech's CSR arm) focus on continuous global sustainability commitment with a total investment of over $175 million in CSR programs to date. HCLTech is consistently recognized for its commitment to making a positive difference in the environment. Through our technology and collective expertise, HCLTech was recognized as an Industry Mover by S&P Global Sustainability Yearbook 2023 for sustainable business practices and continues to partner with leading U.S.-based organizations, including Feeding America and Girl Up, to serve the broader community. For more information on HCLTech Climate Action Grant in the Americas, its mission and the application process, please visit About HCLTech HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, High Tech, Semiconductor, Telecom and Media, Retail and CPG and Public Services. Consolidated revenues as of 12 months ending March 2025 totaled $13.8 billion. To learn how we can supercharge progress for you, visit For further details, please contact: Meredith Bucaro, Americasmeredith-bucaro@ Elka Ghudial, James Galvin, Nitin Shukla, Indianitin-shukla@ Logo - View original content to download multimedia: SOURCE HCLTech View original content to download multimedia: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
