FDA approval of the first non-medication device for ADHD leaves us with more questions than answers.


Will this device mark the transformation of ADHD treatment?

This week, USA Today announced the FDA’s approval of the first-ever device to treat ADHD. Prior to this, only medication has been FDA approved for treatment of attention deficit hyperactivity disorder. Like medication, this device comes with a unique set of potential side-effects. In addition, it is only approved for patients ages 7-12 years who are not taking prescription medication for ADHD.

It’s ironic that the device requires a screen - as you may have seen recent articles referencing the increase in ADHD symptoms or behavioral issues for young children who have been exposed to more than 2 hours of screen time per day. However, I’m curious to see where this 62-patient 4-week study for the Monarch device from NeuroSigma leads us in terms of alternative treatment options. Like brain training and neurofeedback, what I long to see is data for 2+ years post-treatment/use. Per the FDA, the study was performed as a monotreatment, which means that the patients were receiving no other type of treatment for ADHD. (see article HERE)

I know you're wondering if I would I give it a go with my own kiddos? Perhaps, but not without a lot more data. You know me, I like to dig into the details. I’d need to better understand the device and treatment protocols, parent training for at-home use, etc. I would be curious to know how well it works as part of a multi-modal treatment plan that includes therapy, coaching, parent training, and/or education. These details would help me formulate my decision.

In the interim, I took a look at the device details available. Here’s what the Monarch eTNS entails:  

  • How it works: The device is designed for at-home use under adult supervision. A screen/device is attached to electrode pads that are placed on the patient’s forehead. The device sends low electric impulses that stimulate the trigeminal nerve, targeting areas of the brain responsible for regulating attention, emotion, and behavior.

  • Potential Benefits: Statistically significant improvements seen in the ADHD-RS-IV Scale(p=0.005) and CGI-I assessment(p=0.003) when compared to the control group.

  • Potential side effects: include drowsiness, an increase in appetite, trouble sleeping, teeth clenching, headache and fatigue.

I have so many questions. Why the age limit? Likely a result o the limited study, but on a broader sense, what led researchers to conduct the experiment on such a narrow age range? How much parent training and monitoring is necessary? What are the restrictions? How likely are the side effects to occur? How long do they last? What exactly are you stimulating in the trimgeminal nervous system? What if I put the electrodes in the wrong spot? How does this compare to increased time outdoors or mindfulness or good sleep hygiene?

NeuroSigma is a life sciences company developing bioelectronic technologies focused on TNS neuromodulation therapies for epilepsy and other neurological-based disorders such as ADHD. Based in California and licensed exclusively from UCLA, they have recently expanded into the Asian market as well.

There are other players in the non-medication device sphere of treatment that are at play. Also seeking FDA approval is Akili Interactive Labs, creator of the video-game AKL-T01 designed to improve attention and focus of ADHD. Akili has offices in both Boston and the San Francisco Bay area. You can read more about the game therapeutic pilot here: https://www.mobihealthnews.com/content/pilot-study-akilis-digital-adhd-therapy-feasible-well-liked-autistic-children-parents

Both treatments are intriguing. The studies that support their efficacy are small samples - a bit too small for my taste, but leading in the right direction.  As I tell any parent wo asks, when considering a new or non-medication treatment option, the choice is personal. I would like to see larger population samplings and longer study periods in both. And that will require time. I may have considered volunteering my child for the Monarch eTNS study, but since he is far beyond the age limit of 12 years it is a moot point. I would have jumped more readily into the Akili Pilot. I am still a little bothered by the screen time for both. I'm not sure how much more relief you get from either vs letting your child run wild in the woods for a few hours - I saw a lot of relief from restricting screens at the under 12 age range and increasing time playing independently in the back yard.