FDA approves first medical device for treating ADHD in children

[clozareal]

What do you all think about this?

FDA signs off on first medical device for treating ADHD in children

As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of ADHD could soon hit the market.

www.usatoday.com

Called the Monarch external Trigeminal Nerve Stimulation (eTNS) System, the prescription-only device is for children ages 7 to 12 who are not taking ADHD prescription medication.

The Monarch eTNS – an instrument the size of a cellphone – is designed for use at home with adult supervision. It connects via wire to a small patch placed on the forehead of the patient, generating a low-level electrical pulse to the brain.

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[Old&InTheWay]

It’s interesting but I don’t really care until they compare it head to head with stimulants.

 

[Stagg737]

It’s interesting but I don’t really care until they compare it head to head with stimulants.

Eh, if they can show that it's legitimately efficacious then I'd consider it. I've already encountered plenty of parents who refuse to put their kids on stimulants, so having another valid option would be nice even if it's not as effective. I'd also be interested to see if this is more/as efficacious as the non-stimulants (atomoxetine, bupropion, etc) as well.

 

[WisNeuro]

I'd want to see the RCT data. Way too many things out there that are statistically significant, but not even close to the level of clinically significant. The FDA needs to hire people who actually know how to evaluate research and not rely on meaningless p-values.

 

[clausewitz2]

I'd want to see the RCT data. Way too many things out there that are statistically significant, but not even close to the level of clinically significant. The FDA needs to hire people who actually know how to evaluate research and not rely on meaningless p-values.

I mean biomedical research generally needs to get beyond the fetishization of significance testing. Even psychology, where I think these issues are much better understood, is not at that point yet based on what gets published.

 

[WisNeuro]

I mean biomedical research generally needs to get beyond the fetishization of significance testing. Even psychology, where I think these issues are much better understood, is not at that point yet based on what gets published.

Depends on the niche area, really. Some areas do much better than others with appropriate effect sizes and analyses. The FDA foes beyond ineptness with mere significance testing. Such as allowing clinical trials analyses that clearly violate the assumptions of the analyses several times over. All of science can do a better job, but the FDA should actually hold itself to a higher standard as its decisions directly affect the health and mortality of millions. Not too mention, billions depending on the product that is being shilled. Lots of FDA approved placebos out there have made tens of billions.

 

[SourceOfDenial]

Couldn’t the kid just put their face against the TV or microwave? Save the family some money?

 

[thoffen]

Like many approved devices, seems impossible to blind, thus we can never know how much of its effects are placebo. But, yeah, if it helps and isn't cost prohibitive, it's nice to have the option.

 

[WisNeuro]

I did a cursory lit search for blinded, sham control trials, and all I can find are some articles looking at qEEG as an outcome measure. Anyoen have a citation for this that uses something that is actually validated as an outcome? Or know where to find the FDA trial data?

 

[clausewitz2]

Get ready for the flood of copy cats via the 501(k) process.

 

[theduderino]

There is a sham controlled single site RCT published in the orange journal. There was evidence of a reasonable effect size compared to sham over a five week period. They also included a one week discontinuation period in the study - both arms deteriorated at about the same rate so there are questions about the durability of treatment.

 

[clozareal]

The two industry-sponsored studies came out of the ADHD research group at UCLA and I've linked them below. I agree with theduderino above in that there's a reasonable effect size compared to sham. The effective size of eTNS (cohen d of 0.5) is similar to non-stimulants (atomoxetine has a cohen d of 0.4-0.6) which isn't too far from the effect size of stimulants (cohen d of 0.7-0.9).

An eight-week, open-trial, pilot feasibility study of trigeminal nerve stimulation in youth with attention-deficit/hyperactivity disorder - PubMed

TNS therapy for youth with ADHD appears to be both feasible and without significant risk. Subjective improvements on rating scales and laboratory measures of cognition suggest a potential role for TNS in treating ADHD that merits further investigation. Future research in anticipation of...

www.ncbi.nlm.nih.gov

Double-Blind, Sham-Controlled, Pilot Study of Trigeminal Nerve Stimulation for Attention-Deficit/Hyperactivity Disorder. - PubMed - NCBI (the orange study journal theduderino cited above)

 

[WisNeuro]

I'm a little concerned about the sham condition. In one study, it seems that it was just the device, with no active current. And, their Early Impression Questionnaire does not actually directly ask about whether or not they think they are in sham or active, and also should have been asked at intervals throughout the RCT period. I'm not convinced that the blinding was actually achieved here, which raises the chances of just seeing a placebo effect.

 

[Par4thecourse]

What do you all think about this?

FDA signs off on first medical device for treating ADHD in children

As diagnosis rates of ADHD among children skyrocket, a new medical device for the treatment of ADHD could soon hit the market.

www.usatoday.com

"While the exact mechanism of eTNS is not yet known, neuroimaging studies have shown that eTNS increases activity in the brain regions that are known to be important in regulating attention, emotion and behavior." FDA
Parents apply the device used while sleeping and observe and record behavior. So, the testing isn't double blind.

I'd try it if I was 7. Wait, is that chronological or maturation
age?