With one in seven American children and teens now diagnosed with attention-deficit/hyperactivity disorder (ADHD) and psychostimulant medication (amphetamines such as Ritalin and Adderall) commonly used to treat the condition, often generating a range of adverse effects, the demand for alternative treatments has surged in recent years.
Mindful of that need, last Friday the FDA approved the first non-drug device to treat the disorder. Aimed at children aged 7 to 12, the prescription-only device—called the Monarch external Trigeminal Nerve Stimulation (eTNS) System—is described in an agency press release as “innovative, safe, and effective” in treating children who have difficulty staying focused and paying attention, two of the key criteria listed for a diagnosis of ADHD.
“While the exact mechanism of eTNS is not yet known,” the FDA acknowledges, “neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion, and behavior.”
