The first device approved by the FDA to treat ADHD, explained

For decades, managing ADHD meant getting a prescription for Adderall or Ritalin. Now, children have another option: the Monarch External Trigeminal Nerve Stimulation System (eTNS), an ADHD treatment device that works by sending light electrical stimulation shocks to the nervous system.

The Food and Drug Administration has authorized the device to be marketed as a treatment for patients aged 7 to 12 years. Here's what you need to know about Monarch eTNS.

First, what is ADHD and how is it diagnosed?

Attention-Deficit Hyperactivity Disorder is a common condition that starts in childhood and is often difficult to manage. Symptoms include inattention, difficulty concentrating, impulsivity and intense activity.

To be diagnosed with ADHD, a person must show persistent inattention and persistent hyperactivity that interferes with important aspects of life. An example of inattention is the fact of not paying attention to the details of school work, while the hyperactivity includes agitation, excessive blur or speech and spontaneous movements, such as jumping or jumping. run.

In addition, several symptoms must have been present before the age of 12 and several symptoms must be present at more than one place. For example, a child may be careless and hyperactive in school and in the car.

What is the Monarch eTNS system?

The Monarch eTNS is a newly launched medical device that attaches to the forehead via a patch and a small wire. It is just above the eyebrows and provides a slight tingling sensation on the skin, an effect of low level nerve stimulation.

The Monarch system comes from California-based life sciences company NeuroSigma, which develops treatments and devices for neurological disorders.

How does the Monarch eTNS work?

The electrical impulses of this cell-phone-sized device interact with the trigeminal nerve, which then sends therapeutic signals to parts of the brain believed to be responsible for the symptoms of ADHD.

"This new device provides a safe and non-drug option for the treatment of ADHD in pediatric patients through a mild nerve stimulation, a first of its kind," said Carlos Pena, director of the division's Disease Devices Division. physical and neurological medicine of the FDA. declaration.

The FDA has approved Monarch eTNS for the management of ADHD symptoms after reviewing a double-blind, randomized, controlled trial of 62 children with moderate-to-severe ADHD. The details of the essay were published in the Journal of the American Academy of Child and Adolescent Psychiatry in January. In the study, 32 children with ADHD used the Monarch eTNS device every night and 30 children with ADHD used a placebo device.

Children who used the true device during the four-week test period experienced a greater reduction in their symptoms than children who used the placebo.

What are the side effects and is it safe to use?

According to the authors of the 2019 study, one of the great advantages of the Monarch eTNS system is the apparent lack of serious health risks. The study notes that side effects include drowsiness, an increase in appetite, sleep disturbances, fatigue, headaches and screeching of the teeth.

Although marketed as extremely safe, Monarch eTNS is intended to be used only under the supervision of a manager. In addition, treatment with the Monarch system takes about a month before the symptoms visibly improve. It is recommended that children who use Monarch eTNS consult their doctor after four weeks to evaluate the effects of treatment.

Children who use the following software should not use Monarch eTNS:

• A pacemaker or other implanted device.
• An insulin pump or other medical device worn on the body.
• Medications prescribed for the treatment of ADHD, such as Adderall or Ritalin.

How can I get the Monarch eTNS?

Monarch eTNS is already available in Canada, Australia and Europe for the treatment of epilepsy and depression. There is no US release date yet.

Monarch eTNS is available only with a prescription, which requires a diagnosis of ADHD.

In addition, children may only use Monarch eTNS if they are not currently using prescription medication to manage ADHD symptoms. It is also recommended that children with pacemakers, insulin pumps or other bodily devices do not use the Monarch system.

What does this mean for future ADHD treatments?

The marketing approval of Monarch eTNS by the FDA sets a precedent for similar devices to follow.

"This action creates a new regulatory classification, which means that the following devices of the same type with the same intended use can go through the FDA's 510 (k) pre-market marketing process, whereby the devices can obtain a marketing authorization by demonstrating substantial equivalence to a predicate device, "The FDA wrote in its statement.

This precedent will allow similar devices to follow the FDA approval process much more quickly.

The information in this article is for educational and informational purposes only and does not constitute medical or health advice. Always consult a doctor or other qualified health professional for any questions regarding a health problem or health goals.