What is the efficacy of the Monarch external Trigonal Neural Stimulation (eTNS) system in treating Attention Deficit Hyperactivity Disorder (ADHD)?

From the Guidelines

The Monarch eTNS system should not be recommended as a primary treatment for ADHD due to the sparse and limited evidence supporting its efficacy and safety. The American Academy of Pediatrics clinical practice guideline for the diagnosis and evaluation of ADHD emphasizes the importance of FDA-approved medications and evidence-based behavioral interventions as the primary treatment options for adolescents with ADHD 1. While the Monarch eTNS system is an FDA-approved non-drug treatment option, the current evidence supporting its use is limited to a single 5-week randomized controlled trial with only 30 participants, which is insufficient to establish its long-term safety and efficacy 1.

Key points to consider when evaluating the Monarch eTNS system for ADHD treatment include:

• The device's mechanism of action involves delivering mild electrical stimulation to branches of the trigeminal nerve through a small patch placed on the forehead during sleep
• Clinical studies have shown improvements in ADHD symptoms after about 4 weeks of regular use, but these findings are based on limited evidence
• Potential side effects are generally mild and may include headache, fatigue, teeth grinding, or skin irritation at the application site
• The device requires a prescription and may not be covered by all insurance plans, with costs potentially including both the device itself and ongoing electrode patches

In contrast, FDA-approved medications and behavioral interventions have a strong evidence base supporting their effectiveness in reducing ADHD symptoms and improving function, with a strong recommendation (Grade A) from the American Academy of Pediatrics 1. Therefore, the Monarch eTNS system should not be considered a first-line treatment option for ADHD, and its use should be approached with caution until more extensive studies on its efficacy and safety are conducted.

From the Research

Monarch eTNS System and ADHD

• The Monarch eTNS system is not mentioned in the provided studies, therefore, there is no direct evidence to support its use in treating ADHD.
• However, the studies do discuss various treatments for ADHD, including pharmacological options such as methylphenidate and atomoxetine 2, 3, 4.
• Methylphenidate has been shown to be effective in reducing hyperactivity and inattention in children and adolescents with ADHD 2, 3.
• Atomoxetine has also been found to be effective in reducing inattention and hyperactivity in children and youth with ADHD 2.
• The studies also highlight the importance of considering the pharmacokinetic properties of different medications, as well as individual patient needs and dosing preferences, when selecting a treatment for ADHD 5, 6.

Treatment Options for ADHD

• Methylphenidate is a commonly used medication for ADHD, and has been shown to be effective in reducing symptoms in both children and adults 2, 3, 4.
• Atomoxetine is another medication that has been found to be effective in reducing symptoms of ADHD 2.
• The choice of medication and dosing strategy should be individualized based on patient needs and response to treatment 5, 6.
• Flexible dosing strategies, which allow for adjustments to be made based on patient response and tolerability, may be associated with improved efficacy and acceptability 6.

Limitations of Current Evidence

• The quality of evidence for many ADHD treatments is low or very low, highlighting the need for further research in this area 2.
• There is a lack of data on the long-term effects of using high doses of stimulants in clinical practice 6.
• More research is needed to fully understand the effects of different treatments and dosing strategies on ADHD symptoms and patient outcomes.