FDA Approves Device for Children with ADHD

FDA Approves Device for Children with ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is a mental health disorder that most often occurs in children. In fact, according to The A.D.D. Resource Center, there are 6.4 million American children aged 4-17 diagnosed with ADHD today. This disorder affects children of all races, genders, and ages in all 50 states, and across all socio-economic thresholds. Diagnoses are on the rise in recent years, and finding treatments other than prescription drugs has become a priority.

 

Nerve-Stimulating Medical Device to Treat ADHD

This safe, non-drug option for treating ADHD is called Monarch external Trigeminal Nerve Stimulation (eTNS) System, a product of NeuroSigma. According to the April 19, 2019 FDA News Release, this new device is intended for patients ages 7 to 12 who currently take no prescription ADHD medication.

 

How It Works:

  • It is intended to be used in the home under caregiver supervision.
  • The cell phone-sized device connects with a patch that adheres to the child’s forehead.
  • Low-level electrical pulses move through the device and stimulates the trigeminal nerve, sending therapeutic signals to the parts of the brain affected by ADHD.
  • The stimulation feels like tingling on the skin.
  • In up to four weeks parents may see effects of treatment, including changes in attention, emotion, and behavior.

 

The Clinical Trial: What We Know

The study, involving 62 children with moderate to severe ADHD took place over four weeks of Monarch eTNS System use. Children were either given the eTNS device or a placebo device for the four weeks of use. At the end of the trial, the active group decreased significantly in ADHD symptoms. The placebo group decreased only slightly.

 

Side Effects and Counterindications

There were no serious side effects or events associated with eTNS use during the clinical trial. Common side effects did occur and can include drowsiness, appetite increase, difficulty sleeping, teeth clenching, headache, and fatigue.

 

This device is not safe or intended for use in children younger than six years. Patients with implantable pacemaker or active implantable neurostimulators should not use eTNS. The device should no be used in the presence of radio frequency energy (MRI, cell phones)

 

What This Means for You

Since the FDA granted marketing authorization, it is possible to obtain the Monarch eTNS System for your child. Talk with your doctor about this treatment or check out Monarch’s website for more information [http://www.monarch-etns.com/get-monarch#top].

 

 

FDA Approves Device for Children with ADHD

Meet the Author:

Rachel Ashworth


Rachel Ashworth is originally from the Midwest, her expertise is writing research-based articles about health and wellness. Specific interests include mental health and addiction. Rachel has written on a wide range of topics including parenting, fitness, health, fire safety, home maintenance, medical insurance, and dental care. She spends her time writing, volunteering with her church and community, and teaching her children.


Rachel Ashworth is originally from the Midwest, her expertise is writing research-based articles about health and wellness. Specific interests include mental health and addiction. Rachel has written on a wide range of topics including parenting, fitness, health, fire safety, home maintenance, medical insurance, and dental care. She spends her time writing, volunteering with her church and community, and teaching her children.