Have You Heard of the Monarch eTNS Device for ADHD?
ACN Report
New options for treating symptoms of Attention Deficit Hyperactivity Disorder (ADHD) are constantly being pursued. One of the latest developments gaining attention is Monarch eTNS®. External trigeminal nerve stimulation (eTNS) avoids the classic negative side effects associated with most ADHD medications. The System is a non-invasive, prescription-only medical device designed to treat pediatric ADHD in children aged 7 to 12 who are not currently taking prescription ADHD medications.
Most impressive is that it’s the first FDA-cleared device of its kind for ADHD treatment. Approved in 2019, it was developed by NeuroSigma, a California-based bioelectronic medical device company. In addition to ADHD, the company is pursuing indications for this device to include a wide spectrum of neurological and neuropsychiatric disorders, drug-resistant epilepsy, and depression.
How It Works
The Monarch eTNS System delivers low-level electrical pulses through a small patch placed on the child’s forehead, just above the eyebrows. These pulses stimulate the trigeminal nerve, which is connected to brain regions involved in attention, behavior, and emotion regulation. Using the trigeminal nerve as a conduit, neuroimaging studies suggest that eTNS increases activity in these brain areas, potentially improving ADHD symptoms.
Effectiveness Based on Clinical Studies
In a 4-week clinical trial involving 62 children with moderate-to-severe ADHD, the active treatment group using the Monarch eTNS System showed a significant reduction in ADHD symptoms compared to the placebo group.
ADHD Rating Scale IV scores (a scaled rating system that measures the severity of ADHD symptoms regarding inattention and hyperactivity/impulsivity) decreased more in the active treatment group, from 34.1 to 23.4 compared to 33.7 to 27.5 in the placebo group.
Usage Instructions
Monarch eTNS System is used at home during sleep, under the supervision of a caregiver, and shouldn’t disrupt the child. An adhesive pad is placed on the child’s forehead and is connected to a device about the size of a cell phone. While on, some have described the feeling as a light tingling sensation, but it is not painful.
Treatment typically lasts for several hours or overnight. It should be used every day for the best results, though users can take a few days off here and there without significantly losing the benefits.
Caregivers should follow the manufacturer’s instructions and consult with a healthcare provider to assess treatment effects after four weeks of use.
Safety and Precautions
This has been studied for children at least 7 years old. It is not suitable for individuals with implanted cardiac or neurostimulation devices, or those with certain other medical conditions. Common side effects reported include drowsiness, increased appetite, trouble sleeping, teeth clenching, headache, and fatigue. Caregivers should ensure it’s not used near sources of radiofrequency energy, such as MRI machines, cell phones, and certain medical equipment.
Availability
The Monarch eTNS System is available through prescription and is intended for use under the guidance of a healthcare provider. At this time, insurance coverage is not likely, though patients are encouraged to consult with their insurance provider and healthcare professional for more information. As of Spring 2025, Dr. Colin Kealey, President and CEO of NeuroSignma, indicated the current cost of the Monarch eTNS System, which comes with a 4-week supply of adhesive pads is $650. Additional pads can be purchased for $40 for a pack of 7. Costs may vary if purchased from a third-party provider.
Real-World Use
While the clinical trial results are encouraging, long-term effectiveness is still being studied. Some users report improvements in focus, behavior, and emotional regulation, while others may need to adjust the duration or consistency of use to achieve optimal results.
Caregiver feedback has generally been positive, especially for families looking for a non-pharmacological treatment option. Since the device is used at night (during sleep), it is relatively easy for children to use with minimal disruption to their daily routines.
For more detailed information, including device specifications and patient resources, visit the official website: Monarch eTNS System.
Overall Effectiveness
While it’s not a “one-size-fits-all” solution, the Monarch eTNS System can be effective for many children with ADHD, especially for those who are not responding well to traditional medications or prefer a non-medication-based approach. Though the studies are using a rating scale for efficacy, during a brief conversation with Dr. Kealey, it was suggested that it should be obvious if the child is responding to the treatment and the behavioral changes would be easy to see.
UCLA: New Multimillion-Dollar Study
Funded by a $350,000 grant from the National Institutes of Alcohol Abuse and Alcoholism, the pilot clinical trial UCLA will involve 30 children ages eight to 12 with exposure to alcohol during gestation. Parents will be provided a Monarch eTNS System developed by the Los Angeles-based company NeuroSigma, Inc. to be used nightly for four weeks. The parents will keep track of the child’s executive function, sleep habits, negative side effects, and any adverse events. Both parents and children will rate tolerability as well as their satisfaction with treatment.
If the treatment is determined to be feasible and effective, the study would proceed to a randomized crossover clinical trial. The NIAAA is set to provide up to $2.1 million for the three-year trial. Read more
Would you try the Monarch eTNS System with your child or have you already? We’d love to hear your feedback in the comments.
