NeuroSigma gets FDA stamp of approval

Last week, a company called NeuroSigma announced that the FDA has cleared their monotherapy technology, the Monarch eTNS System, which is the first treatment alternative to ADHD medications.

How It Works

The Monarch device is placed on top of the largest cranial nerve on the forehead. This nerve sends signals to areas of the brain that are involved in conditions such as ADHD. The Monarch system provides mild electrical stimulation to this nerve while the child is sleeping, under the supervision of a parent/guardian.

The Research

The research study conducted involved 62 participants, ages 7-12, with moderate to severe ADHD. After 4 weeks of wearing the device while sleeping, the participants showed significant improvements compared to the control group. The FDA considers this a low to moderate risk device as the side effects stated were things like drowsiness and increased appetite.

What This Means

With the rising number of people diagnosed with ADHD each year, it is encouraging to see an alternative treatment option for this disorder. We love to see that parents/guardians and clinicians have options when choosing the right treatment for their particular child, and this has opened the door for many more non-drug treatment options to enter the market. No one treatment fits all, so it is critical for caretakers to have options to choose from. 

At the time of publication of this blog, the device is not yet available for purchase in the United States. 

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