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The first FDA-approved device for treating ADHD is explained

For decades, the management of ADHD has resulted in recipes for Adderall or Ritalin. Now children have another option: Monark External Trigeminal Nerve Stimulation System (eTNS), an ADHD treatment device that works by sending mild electrical stimulation shocks to the nervous system. The Food and Drug Administration gave the unit clearance to be marketed as a treatment for patients between 7 and 12 years of age. 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 begins in childhood and is often difficult to handle. Symptoms include inattention, severity, impulsivity and high level of activity. To be diagnosed with ADHD, a person must exhibit persistent obscurity and hyperactivity that is prolonged and disturbed important parts of life. An example of inattention fails to pay attention to details of school assignments, while examples of hyperactivity include fidgeting, blurting out or excessive speech and spontaneous movements, such as jumping or running. In addition, several symptoms must have been present before the age of 1 2, and several symptoms must be present in more than one site. For example, a child can show attention and hyperactivity in school and in the car. Playing now:Watch this:AI in health care: the future of medicine 05:21 What is the Monarch eTNS system? Monarch eTNS is a newly released medical device that attaches to the forehead via a patch and small thread. It sits just above the eyebrows and gives…

For decades, the management of ADHD has resulted in recipes for Adderall or Ritalin. Now children have another option: Monark External Trigeminal Nerve Stimulation System (eTNS), an ADHD treatment device that works by sending mild electrical stimulation shocks to the nervous system.

The Food and Drug Administration gave the unit clearance to be marketed as a treatment for patients between 7 and 12 years of age. 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 begins in childhood and is often difficult to handle. Symptoms include inattention, severity, impulsivity and high level of activity.

To be diagnosed with ADHD, a person must exhibit persistent obscurity and hyperactivity that is prolonged and disturbed important parts of life. An example of inattention fails to pay attention to details of school assignments, while examples of hyperactivity include fidgeting, blurting out or excessive speech and spontaneous movements, such as jumping or running.

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

2, and several symptoms must be present in more than one site. For example, a child can show attention and hyperactivity in school and in the car.


Playing now:
Watch this:

AI in health care: the future of medicine

05:21

What is the Monarch eTNS system?

Monarch eTNS is a newly released medical device that attaches to the forehead via a patch and small thread. It sits just above the eyebrows and gives a light tingling sensation to the skin, an effect of the low nerve stimulation.

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

How does Monarch eTNS work?

The electrical pulses from this mobile size unit interact with the trigeminal nerve, which then sends therapeutic signals to the brain parts thought to be responsible for ADHD symptoms.

“This new device offers a safe alternative for treating ADHD in children using mild nerve stimulation, a first of its kind,” Carlos Pena, director of the FDA’s division of neurological and physical medical devices, said in one statement.

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

The children who used the actual device for a four-week trial showed a greater reduction in their symptoms than the children who used placebo.

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

According to the authors of 2019, a major advantage of the Monarch eTNS system is the apparent lack of serious health risks. The study notes that side effects include sleepiness, increased appetite, sleep disorders, fatigue, headaches and teeth.

Although marketed as extremely safe, the Monarch eTNS is only intended for use under the supervision of a healthcare provider. Treatment with the monarch system also takes about a month before the symptoms are visibly improved. It is recommended that children using Monarch eTNS check in with their doctor after four weeks to evaluate treatment effects.

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 drugs such as Adderall or Ritalin.

How can I get the Monarch eTNS?

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

Monarch eTNS is only available with prescriptions, which first require an ADHD diagnosis.

In addition, children can only use Monarch eTNS if they do not use prescription drugs to manage ADHD symptoms. It is also recommended that children with pacemakers, insulin pumps or other body parts do not use the monarch system.

What does this mean for future ADHD treatments?

The market approval of the Monarch eTNS from the FDA is a precedent for similar entities to follow.

“This measure creates a new regulatory classification, which means that subsequent units of the same type with the same intended use can go through the FDA’s 510 (k) pre-market process, whereby entities can obtain market authorization by displaying very similarity to a prediction scheme, the FDA wrote. in its statement.

This precedent will allow similar entities to move through the FDA approval process much more quickly.

The information in this article is intended for educational and informational purposes only and is not intended for health or medical care. a doctor or other qualified caregiver regarding any questions you may have about a medical condition or health goal.

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