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FDA Approves New Medical Device For Kids with ADHD »

ADHD (Attention Deficit and Hyperactivity Disorder) is a psychological and biological condition that affects thousands of children.  ADHD is defined by the Attention Deficit Disorder Association as “a highly genetic, brain-based syndrome that has to do with the regulation of a particular set of brain functions and related behaviors.”

As of 2016, The National Survey of Children’s Health reported: 

Approximately 9.4% of children 2-17 years of age (6.1 million) had been diagnosed with ADHD.

    • Ages 2-5: Approximately 388,000 children
    • Ages 6-11: Approximately 2.4 million children
    • Ages 12-17: Approximately 3.3 million children

Treatment and therapy for children with ADHD has been an ongoing study. Currently, there are specialists or therapists who can help teach the parents and the child various methods to handle the behaviors.  There are also many medications available designed to help with minimizing the symptoms in order to afford the child a fairly healthy and successful life.  Sadly, those medications may create mild to severe side effects which can drastically affect the child’s mental and emotional state, as well as some physical ramifications. 

Scientists and pharmaceutical companies have been trying to find a treatment that doesn’t have these negative effects on children.  In April of 2019, the FDA announced their approval of a new device for kids with ADHD.  It is called the Monarch e-TNS System. This is the first ever medical device approved for the treatment of ADHD.  The approval to market the device was granted to the company NeuroSigma.  

What is ADHD and its Symptoms? 

What many people may not realize is that there are 3 forms of ADHD.

1) ADHD Predominate Inattentive type:  This version was previously referred to as ADD or Attention Deficit Disorder.  That designation was removed in 1994.  These children do not demonstrate hyperactivity in their behavior.  They appear as the child who “lives in their own world” and can’t maintain focus or attention for long periods of time.  They tend to respond slower and process information slower.  This type is usually overlooked, as they aren’t overly active or impulsive.  Such behavior usually calls attention to oneself.

The symptoms include:

  • Trouble paying attention (easily sidetracked)
  • Doesn’t like or avoids long mental tasks (such as homework)
  • Trouble staying on task during school, at home, or even at play
  • Disorganized and seems forgetful
  • Doesn’t appear to listen when directly spoken to
  • Doesn’t pay close attention to details
  • Loses things often
  • Makes careless mistakes
  • Struggles to follow through with instructions

2) ADHD Predominately Hyperactive-Impulsive type:  This is the child who can’t sit still, who impulsively interrupts others when they are talking, who talks often, or who creates disturbances in the classroom because they are bored.  They may be more prone to higher frustration levels and angry outbursts. 

Symptoms include:

  • Blurting out answers before a question is finished
  • Constantly interrupting others
  • Trouble waiting his turn
  • Talks too much
  • Fidgeting, tapping, and squirming
  • Gets up when it’s not appropriate (such as when the teacher is talking or in the middle of dinner)
  • Running or climbing in inappropriate situations
  • Unable to play quietly

3) ADHD Combined Type:  This is the child who not only can’t sit still and impulsively acts and reacts to situations, but also cannot focus or maintain attention.  As the name suggests, they are the combination of the above two subtypes.

Diagnosis for any of the ADHD spectrum disorders requires the child to be under the age of 16 and have 6 or more of the above symptoms for at least 6 months.  It is 5 or more months if it is an older teen.  It should be understood that an adult can also be diagnosed with ADHD.  In the case of an adult, it is more likely they were undiagnosed children with ADHD as opposed to developing the condition at an adult age.  

Before a child is diagnosed with ADHD, other factors should also be considered and ruled out: 

  • Learning Disabilities: this could be a reason for difficulties at school
  • Major Life changes: a recent move, trauma, divorce
  • Other Psychological Disorders: anxiety, depression, or bipolar disorder
  • Behavioral Disorders: such as oppositional defiant disorder or conduct disorder
  • Medical Conditions: thyroid problems, epilepsy, or sleep disorders

Medication and Treatment for ADHD

Choosing your child’s treatment can be heart-wrenching for many parents.  The idea of placing a young child on medication with all of the potential side effects is not a decision many parents are comfortable with.  In contrast, learning behavior therapy to both handle the child as a parent as well as teach the child how to handle the symptoms themselves takes time, an open mind and a lot of patience – qualities that not everyone has.  For example, a single parent who needs to work two jobs may find that near impossible to handle.  Parents with multiple children also may have an extremely hard time managing it all.

On the positive side of using medication, the relief for your child can occur as soon as 4 weeks or less.  Being on medication, if effective, can aid the child in improving self-esteem, focusing better, earning better grades at school, having fewer issues at home, and more.  It can also buy some time for them to learn the behavior therapy skills in order to get off of the medication.

Let’s be clear, though; medication is only treating some of the symptoms.  It is not a cure.  They are designed to assist with the most prominent symptoms of hyperactivity, inattentiveness, and impulsivity.  Additional behavior therapy and other methods may still be required to assist with the other symptoms.

The medications which have been used the longest are stimulants.  Ironically, the brain of an ADHD child is actually less stimulated than the average.  Placing them on a stimulant actually increases their brain function, creating a decrease in the hyperactive, impulsive or inattentive symptoms.  The most commonly prescribed stimulants are Ritalin, Adderall, and Dexadrine.

Newer, non-stimulant medications have come out in recent years.  These include Strattera, certain anti-depressants and blood pressure medications.  Generally speaking, using these medications is only advised when the stimulants have not worked well enough or not at all, or when the side effects of stimulants were too severe.

The side effects of stimulants include: 

  • Feeling restless and jittery
  • Difficulty sleeping
  • Loss of appetite
  • Headaches
  • Upset stomach
  • Irritability, mood swings
  • Depression
  • Dizziness
  • Racing heartbeat
  • Tics

There are also mood or personality changes which may occur.  The person may exhibit symptoms of OCD (Obsessive Compulsive Disorder).  They may suddenly be withdrawn and listless.  Behaviors of aggression, anxiety, depression or paranoia may become worse.  Psychosis (delusions or hallucinations) is also possible, especially if there is a family history of depression, bi-polar or suicide.  

There have even been studies that have shown stimulants to cause sudden death for children or adults who may have had an undiagnosed heart condition.

The non-stimulant medications have various side effects as well which can affect mood and cause headaches, sleepiness, nausea, upset stomach and a host of other symptoms.

Behavior therapy is the best long-term option.  Even if you choose to place your child on medication, behavior therapy can not only assist with additional symptoms but also teach symptom management, which can allow the child to get off medication. These therapies can help the child learn to handle stress, anger, and impulsive behaviors.  It can also teach time management, social skills, organization, and goal creation.

In addition to behavior therapy and/or medication, it is highly recommended to ensure the child:

  • Exercises regularly
  • Eats a healthy diet with meals broken up to 6 times a day
  • Gets regular and good amounts of sleep
  • Stays positive in attitude

The Monarch e-TNS System

No one really wants their child on medication if it can be avoided.  As adults, we don’t even want to be on medication, which is what makes the new device, The Monarch e-TNS System, sound like a good potential option for the treatment of ADHD in children. 

The Monarch e-TNS System is approved for patients aged 7-12 who are not currently on medication.  It is intended to only be used under the care of a parent or caregiver and is applied during the child’s sleep time. It is the size of a cell phone and is connected through a wire to a small patch which is placed on the child’s forehead.  The device generates a low-level electrical stimulation to the branches of the trigeminal nerve, which sends signals to the part of the brain associated with ADHD.  The sensation should just feel like a tingling on the skin.

Studies have shown it may take up to 4 weeks to show a decrease in symptoms.  The trials did show that children using the device showed a significant decrease in attention or impulsive behaviors.  The most common side effects were increase in appetite, trouble sleeping, teeth clenching, headaches and fatigue.  

Children with certain medical conditions requiring a pacemaker would not be able to use this device.  All children should be evaluated by their physician to ensure it is safe for their use.

This stands to bring a lot of hope to parents and children with ADHD.  The closer we can get to treating this condition quickly and effectively without potentially dangerous medications, the better.




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