Plug your kid in for the night: FDA's new electric pulse treatment for ADHD

This article will not deal with the validity of ADHD as a diagnosis. What it will address is the validity of a new treatment for ADHD, one which gained FDA approval

• after being tested on just 54 children,
• for only 8 weeks,
• and which involves putting young children to bed at night with electrodes strapped to their foreheads to subject them to almost continuous electrical current while they sleep.

‍

If you’re worried about drug side-effects, try this instead…

The innovative device that is now being promoted as a non-drug treatment for ADHD is called eTNS, which stands for external Trigeminal Nerve Stimulation. The FDA has licensed NeuroSigma to market its Monarch eTNS System for the treatment of children between the ages of 7 and 12 who are not taking any prescription ADHD medication. 

NeuroSigma, in its promotional literature, stresses the downsides of psychiatric drugs for children and claims to offer “another choice”:

Aside from perceived stigmas associated with ADHD, parents and caregivers may have concerns about psychotropic medication for their children. Now there’s another choice ... a noninvasive neuromodulation treatment device based on research funded by the National Institute of Mental Health (NIMH).

‍

Pulses of what?

NeuroSigma stresses the apparent simplicity of its device, and its ease of use:

This non-medication, minimal-risk monotherapy is used by parents or caregivers for at-home treatment of children ages 7 to 12 years who are not currently taking prescription medication for ADHD...

The Monarch eTNS System is convenient and easy to use. Just smooth the disposable patch onto your child’s forehead at bedtime. Turn on and adjust the device for overnight treatment. The pulsing effects are mild and not intrusive. Children have described the stimulation as a tingling sensation on the skin. The treatment works while your child is sleeping. In the morning, remove the patch when your child wakes up.

But what is it? What are these mysterious “pulses”? 

‍

If it looks like electric shock therapy and functions like it too… don’t worry! It is totally different

It may of course be mere happenstance, but it is nonetheless notable that NeuroSigma’s description of eTNS nowhere includes the word “electricity.” The closest it gets to mentioning where the pulses come from is a single sentence that describes,

A cell phone-sized device that connects to a disposable patch placed on the child’s forehead at bedtime...

Other sites that describe the treatment do, however, clarify that the forehead patches transmit electrical current.

Thus, the website of the United Brain Association explains that,

The cell phone-sized device is loosely attached to the child’s pajamas and contains two wires that connect to an adhesive patch that is worn on the forehead, just above the eyebrow. These wires send low-level electrical pulses, described by patients as a tingling sensation, through a wire to the small patch affixed to the patient’s forehead. The therapeutic pulses stimulate the branches of the trigeminal nerve believed to be involved in ADHD. 

They are also quick to add that that although this might sound like ECT—electroconvulsive therapy, which is still in wide use, contrary to what many people believe, it’s really not the same at all:

It’s noninvasive and is nothing like electroconvulsive therapy. The device indirectly stimulates the brain through the cranial nerves, which then send signals to various areas in the brain that we think may be involved in ADHD.

‍

Critics silenced

Monarch eTNS actually is distinct from ECT (also known as electric shock therapy) in that ECT uses currents of up to 1,000 milliamps, whereas eTNS only goes up to 10 milliamps. The two treatments are also distinct in that ECT is a concise series of short, sharp shocks whereas eTNS is administered over around 8 hours, virtually continuously. 

As for the claim that eTNS is “noninvasive,” however, this is simply a marketing gimmick, according to Jessica Baron, writing in Forbes:

While it’s true that the electrodes don’t penetrate your head, they must produce enough current to reach the brain in order to have any effect at all. Calling these products “noninvasive” is merely a marketing technique and a misleading one if you ask me.

Baron’s article has been removed from Forbes’ site; all cached snapshots have been redirected to a “page removed” notice. Her words endure on the CCHR site, which is not precisely mainstream.

‍

Even after decades of experiments, no one knows how it works

What do ECT and eTNS have in common? Both are touted as being beneficial for “treatment-resistant” depression, and both have been around for decades (although eTNS has only recently been approved). And, in both cases, no one really knows how they work.

‍

That hasn’t stopped scientists from using lots of complex terms to describe what eTNS might be doing:

Nearly 5 decades ago, the effect of trigeminal nerve stimulation (TNS) on cerebral blood flow was observed for the first time. This implication directly led to further investigations and TNS’ success as a therapeutic intervention. Possessing unique connections with key brain and brainstem regions, TNS has been observed to modulate cerebral vasodilation, brain metabolism, cerebral autoregulation, cerebral and systemic inflammation, and the autonomic nervous system...

At a mechanistic level, TNS is thought to stimulate the nucleus tractus solitarius, which relays signals to cortical and subcortical structures such as the thalamus, hypothalamus, amygdala, locus coeruleus, reticular activating system, anterior cingulate and insula...

‍

Electrodes for your brain are ‘like glasses for your eyes’

NeuroSigma, by contrast, makes its new product sound extremely simple and straightforward:

The Monarch eTNS System helps to regulate the brain areas linked to ADHD symptoms via the trigeminal nerve, the body's thickest nerve. The trigeminal nerve has branches that terminate close to the skin's surface, just above the eyebrows. This nerve is a significant pathway to critical brain regions associated with attention, mood, and self-control.

Using mild stimulating pulses delivered to the nerve through the skin, the Monarch eTNS System increases activity in these key brain regions. Brain imaging studies have documented these effects.

Their description draws away attention from the multifaceted impact of applying electrical current to the brain, and implies that eTNS’ effect is focused on and confined to the parts of the brain supposedly implicated in ADHD:

Treatment for ADHD is designed to help refocus the brain, much like glasses are used to help near-sighted children see better. [emphasis added.]

Nonetheless, it’s clearly not the case that eTNS is an ADHD-focused treatment, because the same principle has been used (in trials) to treat migraine, epilepsy, depression, PTSD, fibromyalgia, SAD, cognitive/balance dysfunction, pediatric ADHD, PVS, SAH, and secondary issues due to mTBI. In fact, NeuroSigma itself is currently conducting trials on eTNS for PTSD, depression, and epilepsy.

‍

But the FDA approved eTNS. What did its regulators say?

The system delivers the low-level electrical stimulation to the branches of the trigeminal nerve, which sends therapeutic signals to the parts of the brain thought to be involved in ADHD. 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 [emphasis added].

‍

If 92% of kids reported ‘trouble concentrating,’ is it really effective?

Two trials were submitted to the FDA by NeuroSigma. The first, the “feasibility study,” enrolled 24 children (aged between 7 and 14) who were described as having “moderate to severe ADHD"). There was no control group — all the children used the device, for eight weeks. 3 of them dropped out during the trial with no reason for this being supplied.

13 adverse events were reported during the 8 weeks, including 4 cases of headaches, 1 case of eye-twitching, and 1 case of “tingles in the head.” 

Many “side effects” were also reported which were not classified as adverse events by NeuroSigma’s investigators, even though the children reporting them called them either “moderate” or “severe.” Although they were being treated for ADHD, and the FDA considered the treatment effective, 92 percent of the children reported that they had “trouble concentrating” during the trial period. 71 percent reported that they had “trouble sitting still.” 58 percent reported feeling “nervous or hyper,” and 46 percent said that their memory was poor.

21% of the children mentioned experiencing nightmares during the study and a similar number felt drowsy, sleepy, and weak.

The FDA apparently decided that symptoms such as “hyperventilation” and “rapid heartbeat” were also minor side effects and not serious adverse events. They summed up the results as follows:

No serious adverse events were reported, and the treatment was well tolerated...

Individualized study reports are not available. Instead, the efficacy of the treatment is summed up with a table showing sharp drops in ADHD scores, and the following graph:

So, it was all-systems-go for the next stage in the approval process. 

‍

To be continued...

‍

‍

‍

_{Disclaimer: The information contained in this article is for educational and information purposes only and is not intended as health, medical, financial or legal advice. Always consult a physician, lawyer or other qualified professional regarding any questions you may have about a medical condition, health objectives or legal or financial issues.}