The American Academy of Pediatrics offers the current standard of treatment for ADHD in children, as a combination of medication, behavioral therapy, parent training and educational support. The quest to create and demonstrate the benefits of non-medication treatments for ADHD is not new. Practitioners in many cities today offer EEG biofeedback, for example, to treat ADHD absent strong research support. Ongoing research has raised questions about who might be the right candidate for such treatments, what benefits can be expected and how much treatment is required. Other practitioners have touted the benefits of over the counter pills and potions, meditation, yoga and mindfulness training. Many of these treatments may hold promise and continue to be researched. In the Journal of Attention Disorders, the peer reviewed scientific journal for which I am the Editor-in-Chief, we have accepted and published multiple articles examining these treatments. However, it is my opinion that thus far we have yet to demonstrate that any of these non-prescribed medication treatments have proven sufficient efficacy to replace medication in either children, adolescents or adults. Only one of these alternative or complementary treatments has been cleared for safety but not necessarily approved by the U.S. Food and Drug Administration (FDA) for efficacy.
This past April, however, the FDA provided clearance and efficacy for a device touted to treat ADHD specifically in a limited age range of children. The external Trigeminal Nerve Stimulation (eTNS) system is proposed to offer an alternative treatment option for the more than six million children in the United States diagnosed with ADHD.
The eTNS system is designated at this time for children between the ages of seven and twelve years. It is to be administered under the supervision of a parent or other caregiver. It is a small electronic device that delivers low-level electrical stimulation to the brain’s trigeminal nerve. Each night electrodes are applied to the forehead as the child sleeps over an eight-hour period. The device delivers low-level electrical stimulation. This treatment has been studied as a potential aide for depression, epilepsy and even Post Traumatic Stress Disorder in adults. In a single clinical trial, the eTNS system has been shown to produce a statistically significant reduction in ADHD related symptoms. This research was published earlier this year in the Journal of the American Academy of Child and Adolescent Psychiatry (interested readers can find this article in Volume 58(4), 2019). In providing the FDA’s clearance, Carlos Penã, Director of the FDA’s Division of Neurological and Physical Medicine Devices, stated, “This device offers a safe but non drug option for treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a first of its kind.” The FDA’s approval was based on a single study of sixty-two children, ages eight to twelve years of age with moderate to severe symptoms of ADHD. Each child received four weeks of at home treatment using either eTNS system or a placebo device that appeared similar but was inactive.
Compared with the placebo, children who used the eTNS device showed statistically significant improvement in ADHD symptoms with a 30% drop in symptom scores. It is important to note, however, that children receiving the placebo or non-treatment experienced an average decrease of nearly 18% in symptom scores over the same period of time. Approximately half of the children receiving the actual intervention appeared to demonstrate a clinically meaningful improvement. When the group of children receiving actual treatment were evaluated utilizing electroencephalography (EEG), they displayed a significant increase in electrical activity in the middle and right frontal regions of the brain. Interestingly, treatment effect size, or the actual benefit, appeared similar to non-stimulant medications that are used for ADHD such as Strattera and Tenex, but less pronounced than the effects of stimulant medications such as Ritalin and Adderall. It is also important to note that more than half of the children using the eTNS unit experienced side effects, including fatigue, headache and increased appetite. They also demonstrated significant changes in weight and pulse with an average gain of about two and a half pounds and an increase of ten beats per minute after four weeks. The authors of the single study used by the company manufacturing eTNS in applying for their FDA approval interpreted these changes as the device being relatively safe. However, it is clear these preliminary results with a small number of children raise additional questions. The need for further research comparing the eTNS treatment in larger samples of children and in those receiving research demonstrated medication and non-medication to treatments.
Readers interested in further exploring this eTNS system, now branded as “Monarch eTNS System” can find additional information at www.neurosigma.com. As far as I am aware, the device is still not officially marked to consumers. I typically hear from companies marketing alternative treatments given the size of our clinic in Salt Lake City. I have yet to hear from a sales person in regards to this system. Though it is likely the system is not harmful, I am concerned that the FDA decided to endorse this treatment with only a single, small research study absent even a second confirmatory study. Many other alternative and complementary treatments for ADHD can boast the same but have not received such approval. As is always the case, consumers, especially parents of children struggling with ADHD, should do their homework and understand the risks and benefits of whatever treatments they choose for their children. Parents must make every effort to avoid the many scams to be found on the World Wide Web to treat ADHD.
