The latest data suggests that as many as one in seven children (and teens) in the United States has been diagnosed with attention-deficit/hyperactivity disorder (ADHD) and received prescription psychostimulant medication for treatment. In addition, the data says that the proliferation of the most common of these medications—namely Ritalin and Adderall—could be contributing to a new generation of adverse effects. And these side effects have increased public concern over the safety of these medications, which in turn have increased demand for alternatives.
With that in mind, then, it makes sense that the FDA has been looking to approve new treatments that could help treat ADHD in children between the ages of 7 and 12. This is actually the first non-drug intervention aimed at treating the disorder; with a medical device. It is called the Monarch external Trigeminal Nerve Stimulation System (eTNS) and has been described as an “innovative, safe, and effective” for treating children who experience difficulty with paying attention and staying focused. These, of course, are two hallmarks of ADHD diagnosis.
The eTNS device is only about the size of a cell-phone and its purpose is to send a low-level electrical pulse to specific parts of the brain that scientists believe are involved with “selective maintenance of attention.” The device emits a signal to the brain through a small patch that simply adheres to the forehead to produce a “tingling sensation on the skin.”
While the FDA has definitely approved this device, they are still not sure why or how it works. For now, though, studies continue to show that “eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior,” says the FDA.
The study is limited, however, analyzing data from only 62 children between the ages of 8 and 12. These children were either given an active eTNS treatment or a placebo TNS treatment during sleep for four straight weeks. And even in this study, it was determined that “only slightly more than half of those receiving therapy [experienced] clinically meaningful improvement.”
This, of course, shows promises but also raises more questions about overall efficacy and safety, particularly in a more long term objective.
The result of this study will appear in the upcoming issue of the Journal of the American Academy of Child & Adolescent Psychiatry.