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What is Monarch eTNS® System for ADHD?

The Monarch eTNS® (External Trigeminal Nerve Stimulation) System is the first FDA-approved non-invasive medical device used as a treatment for pediatric attention-deficit/hyperactivity disorder (ADHD).

ADHD is a common mental health disorder characterized by the inability to focus (attention deficit), excessive movement or activity (hyperactivity), and impulsivity (acting without thinking things through). It is a chronic debilitating condition that can cause academic difficulties and problems with developing social skills in children and adults.

Monarch eTNS® System works by delivering low-level electrical stimulation to the trigeminal nerve, which is a major nerve in the face. This stimulation is thought to modulate brain activity in areas associated with ADHD symptoms, such as attention regulation and impulse control.

Indications for Monarch eTNS® System

Monarch eTNS® system is indicated for the treatment of ADHD in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

Contraindications for Monarch eTNS® System

Monarch eTNS® system is contraindicated for use in:

  • Patients with metal implants in the head, neck, or upper body region
  • Patients with active implantable devices, such as cardiac pacemakers, defibrillators, or neurostimulators
  • Patient with a history of seizures or epilepsy
  • Children under 7 years old
  • Patients with uncontrolled medical conditions, such as cardiovascular disorders or severe neurological conditions
  • Individuals with skin conditions, such as open wounds, dermatitis, or other skin irritations

How Does Monarch eTNS® System for ADHD Work?

The Monarch eTNS® system consists of a small patch that is placed on the forehead, typically above the eyebrows. This patch contains electrodes that deliver electrical stimulation. The electrical pulses delivered by the device target the trigeminal nerve, which is responsible for transmitting sensory information from the face to the brain. By stimulating this nerve, the device influences neural activity in specific brain regions associated with ADHD symptoms. The stimulation is believed to modulate neural networks involved in attention regulation, impulse control, and other cognitive functions affected by ADHD. It is thought to promote neuroplasticity, which is the brain's ability to reorganize and form new connections, potentially leading to improvements in ADHD symptoms. The Monarch eTNS® System is typically used during sleep. The device is worn overnight, and the stimulation is delivered continuously during this time. This sleep-based treatment approach is designed to maximize the impact of stimulation on brain function, as sleep is a crucial period for neural plasticity and consolidation of learning.

After Treatment Phase

After using the device for a period of time, follow-up evaluations may be conducted to assess the response to treatment. This may involve evaluating changes in ADHD symptoms, cognitive function, and overall well-being. Treatment parameters, such as the intensity and duration of stimulation, may be adjusted based on individual responses and feedback from healthcare providers. The duration of treatment can vary depending on individual needs and response to the therapy.

Side Effects of Monarch eTNS® System

The most common side effects observed with Monarch eTNS® system use include:

  • Drowsiness
  • Increase in appetite
  • Trouble sleeping
  • Headache
  • Fatigue
  • Teeth clenching
  • Skin irritation at the patch site

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For informational purposes only, a link to the federal Centers for Medicare and Medicaid Services (CMS) Open Payments web page is provided here. The federal Physician Payments Sunshine Act requires that detailed information about payment and other payments of value worth over ten dollars ($10) from manufacturers of drugs, medical devices, and biologics to physicians and teaching hospitals be made available to the public.

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