FDA Approves a New Non-Medication Treatment for ADHD

Attention Deficit Hyper Disorder (ADHD) is one of the most commonly diagnosed neurological conditions in school-age children, affecting over six million children in the United States. Symptoms of ADHD include inattention, hyperactivity, and impulsivity. ADHD typically begins in childhood and can persist into adulthood, and may contribute to low self-esteem, depression, delinquent behaviors, and difficulty at school or work.

According to the Centers for Disease Control and Prevention (CDC), about three out of four children receive treatment for ADHD, be it medication, behavior treatment or a combination of the two. Deciding on a treatment plan for ADHD can be a difficult decision for parents, however, parents now have another option, as the FDA recently approved the first-ever non-stimulant medication as an effective alternative.

The Monarch eTNS (external Trigeminal Nerve Stimulation) is created by NeuroSigma, a California-based life sciences company that focuses on manufacturing TNS devices for neurological disorders. This system provides a safe, noninvasive new treatment option for ADHD – one that would avoid medication.

Monarch eTNS treats the symptoms of ADHD by sending gentle electrical pulses to the trigeminal nerve, which activates the neural pathway to other parts of the brain thought to be involved in ADHD. Neuroimaging studies have shown that eTNS increases activity in brain regions that are known to be important in regulating attention, emotion, and behavior.

Sandra Loo, co-principal investigator of the study and professor-in-residence of psychiatry and biobehavioral sciences at the David Geffen School of Medicine at UCLA and a member of the Jane and Terry Semel Institute for Neuroscience and Human Behavior, says, “A head-to-head study has not been done, so we can only compare how effective the treatments were in their own clinical trials. Trigeminal nerve stimulation performed better than other non-drug treatments, like behavior therapy, and is roughly equivalent to nonstimulant medications used to treat ADHD, such as guanfacine and atomoxetine.”

How Monarch ETNS Works

The Monarch eTNS System is meant to be used at home under the supervision of a parent or caregiver while the child is sleeping. The cell phone-sized device is loosely attached to the child’s pajamas and contains two wires that connect to an adhesive patch that is worn on the forehead, just above the eyebrow. These wires send low-level electrical pulses, described by patients as a tingling sensation, through a wire to the small patch affixed to the patient’s forehead. The therapeutic pulses stimulate the branches of the trigeminal nerve believed to be involved in ADHD.  According to Dr. Loo, “The direction we give parents is to turn it up until the child feels it, and then turn it down one step. It’s noninvasive and is nothing like electroconvulsive therapy. The device indirectly stimulates the brain through the cranial nerves, which then send signals to various areas in the brain that we think may be involved in ADHD.”

Parents are advised to have their child receive mild stimulation for eight hours nightly. Clinical trials suggest that a response to this form of treatment may take up to four weeks to become evident.

Who Would Benefit?

The FDA’s approval of Monarch eTNS is a breakthrough for many parents with children suffering from ADHD and would be highly desirable for parents seeking to avoid pharmacological treatment, especially following a new diagnosis. The device is also a safe alternative for children who did not respond positively to stimulants or experienced unwanted side effects from ADHD medication.

Available by prescription-only, The Monarch eTNS device is indicated for the treatment of pediatric ADHD as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.

Because there is currently no empirical way to predict if a child will respond to this treatment as opposed to another, the decision to use this form of treatment is based on the clinical expertise of the treating professional, along with the wishes of the parent.

Dr. Loo states, “Hopefully, future research will help us identify individual characteristics that predict which treatment will likely work for that person.”

Side Effects of the Monarch ETNS

No serious adverse events have been associated with using The Monarch eTNS, and the most common side effects observed include:

• Drowsiness
• Increase in appetite
• Trouble sleeping
• Teeth clenching
• Headache and fatigue.

During Dr. Loo and team’s first study of the device, parents reported significant improvements in their children’s sleep, however in the second clinical trial, they did not see any improvement or worsening of sleep in participants. That said, no one stopped treatment because of difficulty sleeping. Further analyses are being done to better understand the effect of TNS treatment on sleep.

Learn More About the Monarch ETNS

New products approved for the treatment of ADHD are not immediately reimbursed by patients’ insurance, however, the company is working diligently with insurance companies to try and obtain coverage for the system by as many plans as possible. The price for the Monarch eTNS System starter kit is $980, which includes everything needed to begin therapy including the controller unit and a 4-week supply of electric patches. Refill electric patches are sold in packages of 7, which cost $70.

Contact your child’s doctor or click here to see if the Monarch eTNS System might be appropriate for your child.

SOURCES

https://newyork.cbslocal.com/2019/04/23/adhd-treatment-electrical-shocks/
https://www.monarch-etns.com/
https://www.cdc.gov/ncbddd/adhd/data.html
http://newsroom.ucla.edu/stories/drug-free-treatment-adhd-children