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The first FDA approved device for the treatment of ADHD



The management of ADHD has been a recipe for Adderall or Ritalin for decades. Now, children have another option: Monarch's External Trigeminal Nerve Stimulation System (eTNS), an ADHD treatment device that sends mild electrical stimulation bursts to the nervous system.

The Food and Drug Administration (FDA) has approved the device as a treatment for patients between the ages of 7 and 12 years. What you should know about the Monarch eTNS:

What is ADHD and how is it diagnosed?

Attention Deficit Hyperactivity Disorder is a common childhood disease that often starts with a difficult time. Symptoms include inattention, difficulty concentrating, impulsivity and high activity.

To be diagnosed with ADHD, a person must have persistent inattention and hyperactivity that is long-lasting and affects vital areas of life. An example of inattention is the failure to notice details about schoolwork, examples of hyperactivity are fidgeting, flaring or over-talking, and spontaneous moves such as jumping or running.

In addition, several symptoms must have occurred before the age of 1

2, and several symptoms must be present in several places. For example, a child may show inattention and hyperactivity at school and in the car.






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What is the Monarch eTNS system?

The Monarch eTNS is a newly released medical device attached to the forehead via a patch and a small cable. It sits just above the eyebrows and causes a slight tingling sensation on the skin, an effect of weak nerve stimulation.

The Monarch System was developed by Californian life science company NeuroSigma, which develops treatments and devices for neurological disorders.

How does Monarch eTNS work?

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

"This new device provides a safe, non-drug option for the treatment of ADHD in pediatric patients through the use of mild nerve stimulation, a premiere of its kind." Carlos Pena, director of the Department of Neurological and Physical Medical Devices of the FDA said in a statement.

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

The children who used the real device during the four-week trial showed a greater decrease in their symptoms than the children who used the placebo.

What are the side effects and is the application safe?

According to the authors of the 2019 study, a major benefit of the Monarch eTNS system is that there are obviously no serious health risks. The study finds that side effects include drowsiness, increased appetite, sleep disturbances, fatigue, headache and teeth grinding.

Although Monarch eTNS is marketed as extremely safe, it may only be used under the supervision of a janitor. In addition, treatment with the Monarch System takes about a month before the symptoms improve significantly. It is recommended that children using Monarch eTNS report to their doctor after four weeks to assess the effects of the treatment.

Children using the following should not use Monarch eTNS:

  • A pacemaker or other implanted device.
  • An insulin pump or other body worn medical device.
  • Prescription ADHD medications such as Adderall or Ritalin

How do 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 only available with a prescription that requires an ADHD diagnosis first.

In addition, children can only use Monarch eTNS if they are not currently using a prescription medicine to treat ADHD symptoms. It is also recommended that children with pacemakers, insulin pumps or other body devices do not use the Monarch System.

What does that mean for future ADHD treatments?

The FDA's approval of the Monarch eTNS sets a precedent for similar devices.

"This action creates a new regulatory classification with the consequence that the same type of equipment of the same use can go through the FDA's 510 (k) pre-market process whereby devices can be given a marketing authorization by having a marketing authorization substantiate substantial equivalence with a predicate, "the FDA wrote in its statement.

This precedent will allow similar devices to go through the FDA approval process much faster.

The information contained in this article is for educational and informational purposes only and is not intended to be used as a health or medical advice. Always ask a doctor or other qualified health care provider if you have questions about a medical condition or health goals.


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